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There is no specific diet for people with rheumatoid arthritis (RA). However, scientists believe that some foods may help ease the swelling that causes pain and stiffness.

This article explains what RA is and looks at some of the foods that might help relieve the symptoms. It also investigates whether some foods make RA worse and highlights some other ways that people can manage their symptoms.

RA is an autoimmune condition. This means that a malfunction of the immune system causes it.

More specifically, RA occurs when the bodys natural defenses attack the joints. This leads to painful swelling called inflammation. RA usually affects the joints in the hands, wrists, and knees. Sometimes, it can affect several joints at once.

The symptoms include painful aching or stiffness in the joints. People may feel extremely tired and weak, and occasionally, the condition can cause a low grade fever. Over time, RA can damage the joints permanently.

RA is a chronic, long-term condition, and there is currently no cure. Most people will have periods of remission, during which they have few or no symptoms. Other times, their symptoms will get worse. Doctors call these periods flare-ups.

People with RA can usually manage the condition by taking medications and making certain lifestyle changes.

Some experts believe that diet can help prevent flare-ups and manage the symptoms of RA. There is no specific diet that research has shown to help people with RA, but some foods may help control the painful swelling and support the immune system.

According to the Arthritis Foundation, many of these foods are part of the Mediterranean diet. They include:

Salmon, tuna, sardines, and anchovies are all rich in omega-3 fatty acids. According to the Arthritis Foundation, these fat molecules help fight the inflammation that causes joint pain in RA.

Fruits and vegetables are rich in antioxidants, which support the immune system. The fiber in fruits and vegetables may also help reduce inflammation.

Some of the best sources of antioxidants include blueberries, blackberries, cherries, strawberries, spinach, kale, onions, and broccoli.

Olive oil contains antioxidants, polyphenols, oleuropein, and oleocanthal. According to preclinical studies, these compounds have anti-arthritic and anti-inflammatory properties.

Nuts and seeds are useful for fighting inflammation. Walnuts, pine nuts, pistachios, and almonds are great sources of monounsaturated fat, protein, and fiber.

Experts recommend eating around one handful of nuts and seeds per day.

Beans are packed with antioxidants and anti-inflammatory compounds, including:

People with RA could try adding pinto beans, black beans, red kidney beans, or chickpeas to their diet.

Fiber is very important for heart and gut health. It can also help lower inflammation.

Some food sources of fiber include:

The Arthritis Foundation note that fats play a role in inflammation. As a result, people with RA should try to avoid trans fats. These are often present in baked goods, margarine, and fried foods.

Fats that people with RA should try to limit include:

Processed foods such as some ready-made meals, fast food, and cookies are often high in these fats. It is best to avoid these food items as much as possible.

The Arthritis Foundation also recommend that people with RA remove nightshade vegetables from their diet for 2 weeks to see whether or not they notice any difference in their RA symptoms.

Nightshade vegetables include eggplant, tomatoes, peppers, and potatoes. However, scientists need to do more research to investigate this theory before drawing any conclusions.

The Centers for Disease Control and Prevention (CDC) offer the following advice to people living with RA.

Many community and patient advocacy groups offer RA self-management courses and workshops. These tend to be free or inexpensive to attend.

During these workshops, people usually learn ways to manage pain, exercise safely, and stay in control of their condition.

When a person has RA, getting regular physical activity eases pain and helps the joints work better. It can also help people with the condition stay healthier for longer.

The CDC recommend getting at least 150 minutes of moderate intensity physical activity every week.

Having excess weight places pressure on the joints. In turn, this can make RA pain worse and prevent people from being active.

Losing just 1 pound (lb) (0.45 kilograms [kg]) of body weight will take 4 lb (1.8 kg) of pressure off the knee joints, for example.

The best way to lose weight and keep it off is by eating a healthful, balanced diet and exercising regularly.

People with RA should speak with a healthcare provider regularly. There are lots of treatment and management strategies available.

By working with their doctor, people with RA can usually maintain a high quality of life.

There is currently no cure for RA. It is a long-term condition that causes painful swelling in the joints.

Some scientists believe that certain foods can help with the symptoms. This is because some foods contain antioxidants, which support the immune system. Others contain compounds that may fight inflammation.

Some other ways to manage the symptoms of RA include staying active and maintaining a moderate weight.

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What is the best diet for rheumatoid arthritis? - Medical News Today

Patients with early, undifferentiated arthritis may benefit from milder or stronger treatments, depending on the number of their risk factors for developing rheumatoid arthritis, researchers say.

If the finding is borne out by further research, clinicians could consider treating some of these patients with hydroxychloroquine, steroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) rather than methotrexate, said Pascal de Jong, MD, PhD, a rheumatologist at Erasmus Medical Center in Rotterdam, the Netherlands

"Maybe those patients with fewer risk factors should get less intensive treatment," he told Medscape Medical News. The study by de Jong and colleagues was published online January 23 in Rheumatology.

The European Alliance of Associations for Rheumatology recommends starting treatment with methotrexate for patients who are at risk for persistent arthritis, which it says is "factually synonymous" with rheumatoid arthritis.

But these recommendations are based on studies involving patients with established rheumatoid arthritis, de Jong said.

In an earlier study, he and his colleagues found that hydroxychloroquine can be just as effective as methotrexate for patients newly diagnosed with rheumatoid arthritis who dont have autoantibodies. This led them to wonder whether their findings might apply to some subgroups of patients with early arthritis.

As an initial test of this idea, they identified 130 patients from the Rotterdam Early Arthritis Cohort (tREACH) trial who had at least one swollen joint but who did meet the diagnostic criteria for rheumatoid arthritis.

They sorted the patients into groups on the basis of the number of risk factors for persistent arthritis. The risk factors were autoantibody positivity (rheumatoid factor and/or anticitrullinated protein antibody), polyarthritis (more than four swollen joints), erosive disease, and elevations in levels of acute-phase reactants.

Thirty-one patients had none of these risk factors, 66 patients had one risk factor, and the remaining 33 patients had at least two risk factors.

After 2 years of follow-up, 74% of the patients who had had no risk factors had recovered from their arthritis and had not taken disease-modifying antirheumatic drugs (DMARDs) for at least 6 months (DMARD-free remission). Among the patients who had had one risk factor, 48% achieved DMARD-free remission.Among those who had had two risk factors, 45% achieved DMARD-free remission. The differences between the group that had had no risk factors and the other two groups were statistically significant (P < .05).

The researchers found that those patients who had been experiencing their symptoms for fewer than 6 months were more likely to achieve disease-free remission.

They also sorted patients into different groups on the basis of the treatments they received. One group of 30 comprised all patients who had been initially treated with methotrexate and included patients who had also received other drugs. One group of 40 received hydroxychloroquine initially, and one group of 60 comprised patients who had received no DMARDs initially and included those who had received NSAIDs or glucocorticoids.

There was no statistically significant difference in DMARD-free remission rates among the treatment groups. However, among those patients who were not treated initially with DMARDs, the chance of sustaining DMARD-free remission for more than a year was lower in comparison with the patients who received methotrexate initially (odds ratio, 4.28; 95% CI, 1.34 13.72; P < .05).

Those patients who had fewer baseline risk factors were more likely to have their medication dosages tapered, and they were at lower risk for flares. Patients with more risk factors were more likely to require an intensificiation of treatment, such as with the use of biologicals.

Methotrexate is more likely to cause side effectssuch as nausea, fatigue, and hair loss than hydroxychloroquine, de Jong said. "If the medication is better tolerated, it also influences the compliance of the patient," he said.

The study could help rheumatologists determine which patients need the most aggressive treatment, agreed Kevin Deane, MD, PhD, associate professor of medicine, Division of Rheumatology, the University of Colorado Anschutz Medical Campus, Aurora, Colorado. "That's a common clinical problem," he said. "Somebody comes in with sort of mild arthritis, and you don't quite know what it is yet."

But he added that more research is needed to understand what treatment works best for those patients whose arthritis has not yet been differentiated. Primary care physicians who suspect inflammatory arthritis should refer their patients to rheumatologists and should test for rheumatoid factors and anticyclic citrullinated peptide, Deane said.

The authors and Deane have disclosed no relevant financial relationships.

Rheumatology. Published online January 23, 2021. Full text

Laird Harrison writes about science, health and culture. His work has appeared in magazines, newspapers, and online publications. He is at work on a novel about alternate realities in physics. Harrison has taught writing at San Francisco State University, UC Berkeley Extension, and the Writers Grotto. Visit him at lairdharrison.comor follow him on Twitter: @LairdH.

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Patients With Early Arthritis May Need Tailored Treatments - Medscape

One of the most common ailments afflicting modern society is the presence of joint pain, largely in knees but also experienced in hips and shoulders. While much of this discomfort can be attributed to repetitive motion compression brought on by either weight or gravity (e.g., repetitive running, weightlifting), a new perspective is offered in potentially alleviating the symptoms of bursitis or arthritis.

To understand how to deal with the joint pain, stiffness or soreness associated with arthritis, one first needs to recognize what is going on, or how the problem started. Multiple forms of arthritis exist, with osteoarthritis (OA) developing due to age and wear and tear within the joint, versus rheumatoid arthritis (RA), which is considered an autoimmune disease.

The symptoms of arthritis generally include stiffness and joint pain. The treatments commonly selected for nonprescription use are either the analgesics (aspirin or acetaminophen based) or are of a category of agents known as nonsteroidal anti-inflammatory drugs (NSAIDs). Topical applications with pharmaceutical compounds are also deployed to provide topical relief through transdermal action. In certain acute cases, corticosteroids are deployed either orally or by direct injection into the affected site where the pain is isolated.

New development in the past few years centers on disease-modifying anti-rheumatic drugs (DMARDs) designed to reduce a hyperactive immune or inflammatory process. The latest approach, which seems to have achieved wider acceptance, is the concept of introducing platelet-rich plasma (PRP) in regenerative medicine into the affected joints.

In addition to promising PRP therapies, research of natural products has yielded some very positive results. Studies indicate Terminalia chebula, collagen, curcumin and vitamin D show promise for joint health.

To read this article in its entirety, check out the Joint health across the life span digital magazine..

Mark A. LeDoux is founder, chairman and CEO of Natural Alternatives International Inc.,an organization established in 1980 with facilities in the U.S. and Switzerland engaged in the research, design and manufacture of nutritional supplement programs and products for multinational clients. He is a proud member and leader of many industry organizations.

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Fresh perspective in dealing with arthritis - Natural Products INSIDER

STEAMBOAT SPRINGS If you suffer from arthritis, its probably no surprise that cold weather can make it worse. But why does this happen? And what can you do about?

Dr. Nicole Cotter, a rheumatologist with UCHealth Rheumatology Clinic in Steamboat Springs, answers those questions and more below.

Arthritis, by definition, is inflammation of the joints, Cotter said. But there are probably more than a hundred different kinds of arthritis.

One main type is osteoarthritis, in which wear and tear breaks down the cartilage that cushions a joint, resulting in pain.

There are also various types of arthritis that are caused by abnormalities in the immune system. Rheumatoid arthritis, for instance, often strikes when someone is in their 30s or 40s.

Theres a misconception that arthritis is just a natural part of getting old, Cotter said. So many people come into my office and say, Im too young to be here, but unfortunately, theyre the perfect age to be there because of the type of arthritis they have.

If you experience joint stiffness and pain, see your health care provider. Early treatment can result in better long-term outcomes, and various treatments can help reduce pain.

Listen to your body, Cotter said. If you think that somethings not right, somethings probably not right.

Most of the time when people have arthritis, cold weather makes them feel worse, Cotter said. There are a lot of different theories as to why.

Cold weather is often preceded by a drop in barometric pressure, which can cause tissues to expand and pain to increase.

When temperatures drop, the fluid in the joint actually becomes thicker, which could worsen pain.

People also tend to be less active in cold weather, and joint pain is typically worse when people are more sedentary.

Its actually not an old wives tale that people with arthritis know when they weathers going to change, Cotter said. Its not clear why, but certainly, cold weather makes arthritis worse.

Cotter recommends three strategies to help decrease arthritis pain due to cold weather stay active, stay warm and stay healthy.

Staying active helps you increase blood flow and reduce stiffness.

For most people with arthritis when they wake up first thing in the morning or get up after being in a car, they feel stiff, Cotter said. By staying active, you help combat that stiffness.

Its also important to keep your body warm. Simply staying warm helps, Cotter said. When your joints are warmer, theres more blood flow to the joint and muscles are more relaxed.

Keep your home warm, use a heating blanket and wear appropriate clothing, including layers, gloves and warm socks. People with arthritis in their hands may find that paraffin wax treatments bring relief.

And you do your best to stay healthy. By getting enough sleep, eating a healthy diet, maintaining an optimal level of vitamin D and getting a flu shot, you will support your immune system, which in turn can help decrease pain.

Remember to be careful on the snow and ice.

If people have arthritis, their balance might not be optimal as joint pain here and there can affect your gait, Cotter said. The last thing we want is for somebody to fall on the ice, so just be cognizant of that.

The good news is that by staying active, warm and healthy, you can make a difference in your pain level in cold weather.

Lifestyle modifications can help to manage those symptoms in a cold environment, Cotter said.

Susan Cunningham writes for UCHealth Yampa Valley Medical Center. She can be reached at cunninghamsbc@gmail.com.

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Monday Medical: Arthritis and cold weather | SteamboatToday.com - Steamboat Pilot and Today

Dr. Sal Iaquinta

A friend says she doesnt do any strenuous exercise in order to keep her hip and knee joints like new for old age. She doesnt want to get arthritis and plans on going to the grave with all her original parts.

I give her credit for being amusing, but does her plan have any merit? Does exercise contribute to arthritis? And does anyone care what you go to the grave with?

When the time comes, the replacement parts Im buried with will be the least of my worries.

It would seem like exercise does contribute to arthritis. We all know the former football player with a bad knee from those years in high school or college. One of the most famous medical studies of all time actually looked at exercise and arthritis, but most people dont know it.

The Framingham study started in 1948 in Framingham, Massachusetts. This longitudinal study of just around 5,200 residents is most well known for its observations on heart disease and stroke. This study showed the risks of cigarette smoking, high cholesterol, high blood pressure and obesity. This landmark study is still going today and one of the things being followed is exercise and its effects. The participants reported exercise and injuries, and even had knee X-rays at the beginning of the study and then later points.

Over the decades, some of the group developed knee arthritis. There was no link between exercise (specifically jogging and walking) and arthritis in both symptoms and radiologic findings on follow-up X-rays. Jogging wasnt worse than walking. Obesity was found to be a risk factor for arthritis, but the more active overweight subjects didnt get arthritis any more than more slender active patients.

What about the flip side is strenuous exercise actually good for joints? An Australian study of about 300 adults found the participants who did the most vigorous weight-bearing (not swimming) exercise had the thickest knee cartilage with one exception those who had injuries.

Taking it another step forward, another study of more than 430 avid runners found no evidence that running caused arthritis throughout 20 years of observation. What they did find was that the runners had less musculoskeletal disabilities than the non-runners. And the runners had a mortality rate 39% lower than the non-runners. These studies have been repeated with college athletes and have not found exercise, even strenuous repetitive exercise, as a risk factor.

So, why is there so much knee arthritis? Injuries. Old injuries have been found to be a leading cause of joint arthritis. Getting back to the old football player, it was the trauma the sprains or cartilage tears or even fractures that contribute to arthritis. Another problem is age. Cartilage loses its ability to heal as you get older.

Your parents might be part of the problem. People inherit the growth pattern of their parents, this includes minor abnormalities in how bones are shaped and how they can lead to arthritis. Being female, women unfortunately are more likely to develop arthritis as they get older.

Lastly, as previously mentioned, being overweight adds a disproportionate amount of pressure on the knees. Every extra pound of weight adds 3 pounds of weight to the knees.

Once you have arthritis is when you switch to the exercises that improve muscle strength without significant weight impact. Walking and swimming are great, and even yoga and tai chi help with balance and flexibility.

So is my friend right? Probably not. Not exercising does not seem to help and another study found that weakness of the leg muscles around the knee seems to be its own risk for arthritis. The cardiovascular and other musculoskeletal benefits of exercise outweigh the risk for arthritis as long as you do it safely.

Having all your original parts in the grave doesnt seem worth it if you never really live. Take a hike theres a whole world out there.

Dr. Salvatore Iaquinta is a head and neck surgeon at Kaiser Permanente San Rafael and the author of The Year They Tried To Kill Me. He takes you on the Highway to Health every fourth Monday.

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Does exercise contribute to arthritis? Heres what research says - Marin Independent Journal

Objectives:Peripheral ulcerative keratitis (PUK) is a severe corneal condition associated with uncontrolled rheumatoid arthritis (RA). Tocilizumab (TCZ) is used to control RA, however, episodes of paradoxical ocular inflammation have been reported in TCZ-treated patients. We report a case series of PUK in TCZ-treated RA patients with ophthalmological and systemic findings and discuss the potential underlying mechanisms.

Methods:Four patients (6 eyes), aged 47-62 years were included. At the onset of PUK, the median duration of RA was 13 years (3-13), and the median treatment with TCZ was 9 months (3-14). Two patients had active disease (DAS 28 > 3.2) and the disease was controlled in 2 patients (DAS 28 3.2).

Results:TCZ was initially replaced by another immunomodulatory treatment in all patients and later reintroduced in 2 patients without PUK recurrence. Corneal inflammation was controlled in all cases with local and systemic treatments, with severe visual loss in one eye.

Conclusion:To summarize, PUK may occur in patients with long standing RA after a switch to TCZ and can be interpreted, depending on the context, as insufficient efficacy or a paradoxical manifestation. These cases highlight the urgent need for reliable biomarkers of the efficacy/paradoxical reactions for biologics.

Keywords:Peripheral ulcerative keratitis; paradoxical manifestations; rheumatoid arthritis; tocilizumab.

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Peripheral Ulcerative Keratitis in Rheumatoid Arthritis Patients Taking Tocilizumab: Paradoxical Manifestation or Insufficient Efficacy? - DocWire...

If youre living with rheumatoid arthritis (RA), your primary care physician can monitor many of your day-to-day healthcare needs. For more comprehensive assessment and treatment, however, you may need to see a rheumatologist.

Rheumatologists are doctors internists or pediatricians who receive special training in diagnosing and treating musculoskeletal disease and systemic autoimmune conditions like RA.

Known collectively as rheumatic diseases, these conditions can cause pain, swelling, stiffness, and deformities in your:

Becoming a rheumatologist requires completing 4 years of medical school, where they receive training as a medical doctor or osteopath. Thats followed by 3 years as a medical resident specializing in internal medicine, pediatrics, or both.

To complete their formal education, a rheumatologist spends 2 to 3 years in a rheumatology fellowship, learning about chronic musculoskeletal and autoimmune conditions and how to treat them.

Once theyve completed the fellowship, the rheumatologist must pass a certification exam administered by the American Board of Internal Medicine.

Rheumatologists must take a recertification exam every 10 years. Theyre also required to take continuing medical education classes to retain their board certification.

A rheumatologist can treat any of the more than 100 known rheumatic diseases and musculoskeletal conditions and injuries, including:

A rheumatologist will gather your complete medical and family history, perform a physical examination, and run certain types of testing.

Rheumatologists commonly test people for the presence of excessive antibody production for suspected autoimmune disorders. To assess musculoskeletal problems, they may order:

All of this information helps them work with you to develop the right treatment plan for you.

Treatment may include:

Rheumatologists also can talk with you about:

Muscle and joint pain are not uncommon, but if you have pain that lasts for more than a few days, visit your primary care physician.

Your doctor can evaluate whether youre experiencing temporary pain from an injury or other inflammatory causes, or if an underlying rheumatic condition may be involved that requires a referral to a rheumatologist.

If the pain youre experiencing gets worse over a short period of time, thats a good indicator that you should see a rheumatologist.

Likewise, if your symptoms decrease with initial treatment, like pain medication, but return once the treatment stops, it may be time to seek out a specialist.

You may want to schedule an appointment with a rheumatologist if you:

Many rheumatic conditions are hereditary, so you should also let your doctor and rheumatologist know if you have any family history of autoimmune or rheumatic disease.

If you have persistent joint, bone, or muscle pain, dont delay seeking treatment. Joint stiffness that lasts more than 30 minutes, especially if its worse in the morning after long periods of inactivity, or any joint swelling should also be promptly evaluated by a doctor.

Rheumatic diseases can lead to permanent damage over time if not addressed in a timely manner. Outcomes improve when these conditions are treated earlier, even for chronic and progressive diseases.

Rheumatologists and orthopedists both treat rheumatic diseases, but in different ways.

Generally speaking, rheumatologists treat rheumatic diseases with nonsurgical interventions, whereas orthopedists perform surgeries to improve function and quality of life.

You may want to see an orthopedist if you:

A good rule of thumb: Unless you have suffered a traumatic injury that requires surgery, see a rheumatologist before you consult an orthopedist.

Rheumatologists specialize in treating RA and other rheumatic conditions. They receive extensive training and education to assess and treat people with these conditions. They can also offer counseling for how to cope with diseases like RA.

You should see a rheumatologist if you have chronic joint or musculoskeletal pain that does not go away on its own or reoccurs after short-term treatment.

Your primary care physician may refer you to a rheumatologist. People with rheumatic diseases typically see rheumatologists for treatment rather than orthopedists, unless they have an acute injury requiring surgery or a chronic condition that does not respond to nonsurgical treatment.

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What Is a Rhuematologist and When Should You See One? - Healthline

MANHASSET, N.Y.--(BUSINESS WIRE)--The burgeoning scientific field of bioelectronic medicine, which features the use of electronic devices to stimulate nerves to treat disease, has shown great promise in alleviating serious health conditions. In a Lancet Rheumatology editorial published, Feinstein Institutes for Medical Research president and CEO Kevin J. Tracey, MD, discussed a recent clinical study that used a hand-held battery-operated electronic device to treat patients suffering from moderate to severe rheumatoid arthritis (RA).

Researchers in a multicenter, uncontrolled, open-label study led by Marsal S, Corominas H, et al., published their findings in Lancet Rheumatology which observed the effects of daily up to 30 minutes of sensory branch stimulation therapy of the vagus nerve. The results showed significant changes in the disease activity and ultrasound and magnetic resonance imaging (MRI) revealed significant improvements. The authors conclude that this alternative treatment should be evaluated in larger controlled studies for RA.

In a thorough review of the research paper, Dr. Tracey, who has been heralded as the founding father of bioelectronic medicine for his discovery of the bodys inflammatory reflex, weighed in on the new findings. Some points raised include the need to better understand what part of the body this stimulation activated and the need for larger controlled clinical trials to answer important questions, including the intensity of the stimulation and optimal length.

initial evaluation of evolving breakthroughs should not be based on what we do not know, but rather on whether the clinical trials are well defined and described, and whether others can replicate the results using appropriate statistics and analytics, notes Dr. Tracey in the Lancet Rheumatology editorial. Important new data from basic science and clinical trials can accelerate the pace of its evolution from alternative quackery to clinical adoption.

The Feinstein Institutes for Medical Research is known as the global scientific home of bioelectronic medicine. Bioelectronic medicine combines molecular medicine, neuroscience, and biomedical engineering to develop innovative therapies to treat various diseases and conditions through targeted stimulation of nerves, including paralysis, arthritis, pulmonary hypertension, and inflammatory bowel disease.

Feinstein Institutes researchers recently discovered that a small cluster of neurons within the brain is responsible for controlling the bodys immune response and the release of cytokines, which leads to inflammation in the body.

About the Feinstein Institutes

The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer in New York State. Home to 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health innovations and outcomes, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us on LinkedIn.

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Study Supports Bioelectronic Medicine to Treat Rheumatoid Arthritis - Business Wire

Regenerative therapies such as stem cells and platelet-rich plasma already play an important role in managing osteoarthritis (OA). Nonetheless, veterinarians have found that response to even these therapies is less than ideal in many cases, prompting researchers to continuously seek novel therapies for this all-too-common musculoskeletal disorder. One of the newest to be unveiled is called bone marrow mononuclear cell (BMNC) therapy. One researcher who presented at the 2020 American Association of Equine Practitioners Convention, held virtually, reported that the equine industry is in critical need for therapies that resolve joint inflammation but preserve tissue healing, and BMNC appears a promising candidate.

Much more than stem cells classically sought for cartilage healing, bone marrow is rich in macrophage progenitor cells, explained James B. Everett, DVM, MS, previously of the Virginia-Maryland College of Veterinary Medicine, who now works at the Equine Surgical Center at ThorSport Farm,in Murfreesboro, Tennessee. Macrophages are a type of white blood cell that play a role in tissue repair and cartilage integrity, and produce the anti-inflammatory mediators, including interleukin-10 (IL-10).

Everett said macrophages in the synovial (joint) membrane are essential for joint health, clearing aggressors, secreting key molecules required for optimal joint function, and forming a shield that protects tissues undergoing repair, similar to a wound scab. However, when the amount of tissue damage overwhelms these housekeeping functions, macrophages stimulate inflammation as a means of recruiting more cells, especially more macrophages, to cope with increased demands for repair.

If this response is efficiently accomplished, macrophages then produce, among other things, high concentrations of IL-10 and resolve the inflammatory process, returning the joint to a healthy state, he said.

Everett emphasized that not all inflammation is bad. This acute inflammation is essential to establish a resolving response, and anti-inflammatory therapies can negatively interfere.

As presented by Everetts colleague Bruno Menarim, DVM, PhD, in a separate session, studies show that BMNCs promote the endogenous resolution of experimentally induced inflammation. To see if these promising features translated to naturally occurring inflammation in live horses, Everetts research team studied 19 horses, dividing them into three treatment groups:

The selected horses were diagnosed with OA in a single joint, and the team injected those joints once with the saline, triamcinolone, or BMNCs. The BMNCs were autologous, meaning veterinarians collected them from each patients own bone marrow aspirate. They processed the aspirate in-house, and the isolated mononuclear cells, composed predominantly of macrophages, were ready to inject into the affected joint within three hours of aspiration.

We found that while objectively assessed lameness (via Lameness Locator) decreased in all three groups, it was only significant in the BMNC-treated horses, said Everett. Further, the treatment was well-tolerated with no adverse events appreciated in this study.

He said that using BMNCs can help reduce the need for chronic use of non-steroidal anti-inflammatory drugs and corticosteroids, which produces potentially harmful consequences. Further, BMNCs preserve the production of molecules such as interleukins and cytokines that are essential for restoring joint homeostasis. Corticosteroids often inhibit these molecules.

The researchers noted that these results support a larger clinical trial using BMNCs in clinical cases of equine OA.

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Novel Bone Marrow 'Ingredient' To Help Arthritic Horses The Horse - TheHorse.com

Arthritis is a condition that causes swelling in the joints. It generally occurs in older adults and has different treatments as per the type of it. So, here are the causes, symptoms and risk factors of this joint ailment.

Arthritis is the swelling of one or more of your joints. Severe joint pain is associated with this condition that becomes worse as we age. Osteoarthritis and rheumatoid arthritis are the two most common types of this condition. The first one causes cartilage to break down and the second one is a disease where the immune system attacks the joints. Treatments of arthritis depend on its type and the main goal of the treatments is to reduce the symptoms.

Symptoms and causes of arthritis

Symptoms of arthritis:

Pain.

Stiffness.

Swelling.

Redness.

Causes of arthritis

Osteoarthritis is caused by the damage in the joints cartilage and it affects the entire joints. It also causes changes in the bones and damages tissues. This disease also causes inflammation in the joint lining.

Rheumatoid arthritis is caused when the immune system attacks the lining of the joint capsule. This lining then becomes swollen and inflamed.

Risk factors of arthritis

A person who is already havinga family history of this condition.

Older adults are more prone to having this disease.

Women are at a greater risk of having rheumatoid arthritis and men are prone to have gout, another type of arthritis.

Any previous injury in the joint may cause this issue.

Obesity is also responsible for this condition as your joints have to take a lot of stress of your body weight.

Some early signs of arthritis:

These subtle signs can tell you if you are about to get diagnosed with this condition:

Fatigue.

Morning stiffness.

Joint pain and stiffness.

Minor joint swelling.

Fever.

Numbness and tingling.

Eye discharge.

Dry mouth.

Difficulty in sleeping.

Loss of appetite.

Weight loss.

Note

Arthritis may make it tough for you to do your daily tasks. So, whenever you see these symptoms persistently, consult your doctor right away.

Also Read:Colon Cancer: THESE are the symptoms, causes and risk factors of this chronic disease

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Arthritis: Symptoms, causes and risk factors of this joint ailment - PINKVILLA

TORONTO, Feb. 1, 2021 /CNW Telbec/ - Celltrion Healthcare Canada Limited announced today that Health Canada has granted a notice of compliance (NOC) for Remsima SC (CT-P13 SC) in Canada for the treatment of adult patients with rheumatoid arthritis (RA).

Rheumatoid arthritis is the most common chronic inflammatory joint disease and approximately 374,000 Canadians over the age of 16 live with rheumatoid arthritis.1

Remsima SC is approved in Canada for use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. Remsima SC should be usedas maintenance therapy after the completion of an induction period with intravenous infliximab.2The Health Canada NOC issued for Remsima SC is based on clinical evidence that showed the clinical response to Remsima subcutaneous (SC) formulation was comparable to CT-P13 IV up to 1 year. It was also shown that switching people with RA from the IV formulation to RemsimaTM SC at Week 30 was comparable to maintaining RemsimaTM SC up to Week 54 (up to Week 64 for safety profile).2,3

"Remsima SC has been shown to have a similar efficacy and safety profile to CT-P13 IV. Remsima SC may also enhance treatment options for the use of infliximab by providing high consistency in drug level and exposure," said Professor Edward Keystone, Professor of Medicine, University of Toronto, Toronto, Canada. "The approval of Remsima SC in Canada provides patients the opportunity to administer the treatment at home, giving physicians and patients more control over their treatment."

With the availability of the subcutaneous formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option. Remsima SC can be injected by patients themselves, which has the potential to save time since it will not require in-clinic administered IV treatment.

As part of Celltrion's strategy to expand its global presence and build a direct sales network, Celltrion Healthcare has established an entity in Canada to manage sales and marketing activities for Remsima SC.

"We are delighted to bring the first subcutaneous form of infliximab to patients, payers and clinicians in Canada. We are proud that RemsimaSC will be the first product to enter the Canadian market under our new direct sales marketing strategy. We plan to strengthen our presence in Canada and support the company's growth,"said Jovan Antunovic, Senior Vice President and Commercial Director at Celltrion Healthcare Canada.

Celltrion has applied for patent protection, until 2038, for Remsima SC in approximately 100 countries throughout North America, Europe and Asia.

Notes to Editors:

About CT-P13 (biosimilar infliximab)4-6

CT-P13 is developed and manufactured by Celltrion, Inc. and was the world's first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra. CT-P13 is approved in more than 94 countries (as of January 2021) including the US, Canada, Japan and throughout Europe.

CT-P13 IV is usually given as 3 mg per kg/body weight in RA and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options: via a pre-filled pen (auto-injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

CT-P13 SC has received EU marketing authorization for the treatment of people with RA and IBD in November 2019 and July 2020, respectively. In the United States, Remsima SC will be reviewed through the new drug pathway by the U.S. Food and Drug Administration (FDA) with the outcome expected by 2022.

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the U.S. FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us

References

1.

Government of Canada. Available at:https://www.canada.ca/en/public-health/services/publications/diseases-conditions/rheumatoid-arthritis.html.

2.

Remsima SC Product Monograph. Celltrion Healthcare Canada Limited, January 28, 2021.

3.

Westhovens R et al. Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial. Rheumatology (Oxford) 2020 Nov 23;keaa580: doi: 10.1093/rheumatology/keaa580.

4.

European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf. Last accessed January 2021.

5.

Yoo DH, Jaworski J, Matyska-Piekarska E et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019.

6.

Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170). Presented at EULAR 2019.

SOURCE Celltrion Healthcare

For further information: Media Relations Contact: [emailprotected], [emailprotected]

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Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the...

SetPoint Medicals march toward getting its bioelectronic platform across the finish line obtained a huge boost this week through a financing.

The Valencia, CA-based company announced it had raised $64 million in a preferred stock financing to help in the development of its bioelectronic platform to treat rheumatoid arthritis (RA).

This financing was led by New Enterprise Associates (NEA) and included returning investors Action Potential Venture Capital, Boston Scientific, Topspin Fund, Morgenthaler, Euclidean Capital, and an undisclosed strategic investor.

New investors including ShangBay Capital, Richard King Mellon Foundation, Ascendum Capital, Asahi Kasei, Catalio Capital Management, BPC Fund, Midas Capital, Revelation Partners, Aethan Capital, Citta Capital, and SVE Capital also participated in this round. William Dai, Founding Managing Partner at ShangBay Capital, has joined SetPoint Medicals Board of Directors in conjunction with this financing. The financing included the conversion of approximately $21M in outstanding convertible debt.

This financing sets us up to start the pivotal trial, which will begin [soon], Murthy Simhambhatla, PhD, president and CEO of Setpoint, told MD+DI. The data from this pivotal trial, which will be from 250 patients at 40 sites, will be used to support a PMA submission.

Simhambhatla added, the pivotal trial is important in generating high-quality data. It is a double-blind sham-controlled trial. Its in patients that have failed one or more biologic drugs or are intolerant of them. Its a second-line therapy. Its not for patients that have failed methotrexate, but patients that have been exposed to at least one biologic drug and have had an inadequate response.

The company is forecasting three years before it can file a PMA submission.

SetPoints device, which is about the size of a coffee bean, won breakthrough device designation in October of 2020. The foundation of the technology is based on impacting the Inflammatory Reflex, a mechanism discovered by SetPoint co-founder Kevin Tracy, said David Chernoff, MD, SetPoints CMO.

The Inflammatory Reflex regulates the immune system by way of the central nervous system. By activatingthe Inflammatory Reflex with targeted electrical pulses to the vagus nerve, the body produces a systemic anti-inflammatory response.

SetPoint isnt stopping with RA and will explore using the platform to treat other disease states.

The same feedback loop that can potentially help patients with rheumatoid arthritis can potentially help patients with Inflammatory Bowel Disease, he said. Weve run a clinical trial in Crohns Disease where we saw reductions in disease activity that are comparable to best-in-class approved drugs.

Simhambhatla added, the immediate priority is to get Rheumatoid Arthritis across the finish line. Once we do that, well turn our attention to Crohns Disease, potentially ulcerative colitis, potentially Multiple sclerosis.

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SetPoint Gives a Jolt to RA Pivotal Trial with New Financing - Medical Device and Diagnostics Industry

Pfizers Xeljanz, an oral JAK (Janus kinase) inhibitor rheumatoid arthritis treatment, has failed to catch up with the TNFi (tumor necrosis factor inhibitor) during a post-marketing study, reigniting the debate over its safety.

The post-marketing safety study, dubbed ORAL Surveillance, compared the safety of taking 5mg and 10mg of Xeljanz twice daily with TNFi in about 4,300 patients with rheumatoid arthritis aged 50 years or older with at least one cardiovascular risk factor.

The company set a co-primary endpoint of the study as the non-inferiority of Xeljanz compared to TNFi regarding major adverse cardiovascular events (MACE) and malignancies, excluding non-melanoma skin cancer. The results showed that the company failed to meet the prespecified non-inferiority criteria for the co-primary endpoints.

Analyzing 4,362 subjects, the number of patients with significant cardiovascular events was 135 (98 in the Xeljanz group and 37 in the TNFi group), and that of patients with malignant tumors was 164 (122 in the Xeljanz group and 42 in the TNFi group).

As Xeljanz failed to provide evidence that it was not inferior to TNFi in both cardiovascular and cancer risk, local industry officials expressed concerns that the U.S. Food and Drug Administration may put further restrictions on the drug or pressure the company to withdraw the drug from the market.

In 2019, the FDA had slapped a boxed warning on Xeljanz 10 mg's product label, cautioning against a higher risk of pulmonary embolism, a blood clot in the lungs that can be fatal. The European Medicines Agency also followed a few months later with a warning that patients with a high risk of blood clots should take caution with any dose of Xeljanz.

"Full study results, beyond the co-primary endpoints, including, but not limited to, secondary endpoints such as pulmonary embolism and mortality as well as efficacy data, are not yet available," Pfizer said. "We are working with the FDA and other regulatory agencies to review the full results and analyses as they become available."

Pfizer's study has also raised safety issues for other JAK inhibitors -- Lily's Olumiant and Abbvie's Rinvoq.

All JAK inhibitors publish boxed warnings regarding the occurrence of this blood clot on their product labels.

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Safety debate reignited over Pfizer's arthritis treatment Xeljanz - Korea Biomedical Review

Both Dr. Lisbet Haglund and Shawn Robbins have earned operating grants worth approximately $300,000 over three years

Dr. Lisbet Haglund and Shawn Robbins have both been awarded strategic operating grants from the Arthritis Society. These grants provide funding for projects that have great potential for improving the diagnosis, prevention and treatment of arthritis.

Both researchers are working on projects related to osteoarthritis. Dr. Haglund, Associate Professor of Surgery, Faculty of Medicine and Health Sciences, is studying therapies that may lead to the first disease-modifying drugs for osteoarthritis of the spine. Robbins, Associate Professor, School of Physical and Occupational Therapy, is conducting a randomized clinical trial aimed at identifying the most effective knee implants for patients with osteoarthritis.

These researchers and these projects hold great promise for the future of arthritis diagnosis, care and prevention, says Dr. SinBevan, Chief Science Officer at the Arthritis Society. We look forward to how this important work will help us solve the unanswered challenges of arthritis.

In 2019-20, the Arthritis Society committed over $4.5million to arthritis research and the development of researchers and clinicians.

Dr. Haglunds project, Senolytic drugs to treat back pain from spine OA, received $300,000 in funding over three years.

World-wide, low back pain due to osteoarthritis (OA) of the spine is the single largest cause of years lived with disability. Current treatments like physiotherapy or medication may reduce pain and slow degeneration of the intervertebral discs in the spine but do not stop the progression of the disease. Senolytic therapy destroys senescent (or arrested) cells that cause inflammation in old tissues, leading to rejuvenation and slower progression of many age-related conditions. Dr. Lisbet Haglund will study two promising senolytic therapies, a natural compound, o-Vanillin, and an approved drug, RG-7112. This study may lead to the first disease modifying drugs for low back pain resulting from OA of the spine.

Robbins project is titledThe effectiveness of medial pivot knee arthroplasty implants at improving gait and clinical outcomes in patients with knee osteoarthritis: A randomized controlled trial. It received $298,723 over three years.

Over 67,000 knee replacements are performed annually in Canada for knee arthritis and 20 per cent of patients remain unsatisfied after surgery. New implants have been designed, called medial pivot implants, which claim to more closely mimic normal knee movements. There has been limited testing of these implants, so their effectiveness and safety are not clear. Dr. Shawn Robbins will compare knee movement before and after surgery for walking and stair climbing, pain, and physical function between patients who had medial pivot or traditional knee replacement implants. A better understanding of the most effective knee implants will help to maximize patient outcomes, minimize negative side effects, and decrease demands on the healthcare system.

See the Arthritis Societys competition results page.

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McGill researchers receive grants from Arthritis Society - McGill Reporter - McGill Reporter

In patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure, a combination of filgotinib and MTX significantly improves signs and symptoms and physical function; however, filgotinib monotherapy is not superior to MTX monotherapy in achieving a 20% improvement in American College of Rheumatology criteria (ACR20), according to study results published in Annals of the Rheumatic Diseases.

Previous studies have reported that treatment with small-molecule Janus kinase (JAK) inhibitors, including baricitinib, upadacitinib, and tofacitinib, can significantly improve clinical signs and symptoms of RA and radiographic progression in patients with no prior MTX exposure. However, the safety profile and risk for adverse events should be considered.

The objective of the current study was to determine the efficacy and safety of JAK-1 inhibitor filgotinib in patients with active RA with limited or no prior MTX exposure.

The 52-week, multicenter, double-blind, phase 3 study (FINCH 3; ClinicalTrials.gov Identifier: NCT02886728) included 1252 patients with RA (mean age, 53 years, 77% women) who were randomly assigned to receive 2:1:1:2 filgotinib 200 mg with MTX (n=416), filgotinib 100 mg with MTX (n=207), filgotinib 200 mg monotherapy (n=210), or MTX monotherapy (n=416), respectively.

The primary study outcome was percentage of patients achieving ACR20 at week 24.

At week 24, compared with 71% of patients who received MTX only, 81% who received filgotinib 200 mg with MTX and 80% who received filgotinib 100 mg with MTX achieved an ACR20 response (P <.001 and P =.017, respectively). A total of 78% of patients who received filgotinib 200 mg monotherapy achieved an ACR20 response, which was not significantly different from those who received MTX monotherapy (71%; P =.058).

Researchers noted a significant improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) at week 24; the least-squares mean of the treatment difference in change in HAQ-DI from baseline vs MTX was -0.20 (95% CI, -0.27 to -0.12; P <.001) and -0.13 (95% CI, -0.23 to -0.03; P =.008) for filgotinib 200 mg with MTX and filgotinib 100 mg with MTX, respectively.

The percentage of patients who achieved 28-joint Disease Activity Score with C-reactive protein less than 2.6 was significantly higher for patients who received filgotinib 200 mg with MTX (54%) and filgotinib 100 mg with MTX (43%), compared with patients who received MTX monotherapy (29%; P <.001 for both) at week 24.

Overall, both filgotinib doses were well tolerated with an acceptable safety profile. Adverse event rates through week 52 were comparable between all treatments.

The study had several limitations, including the inability to adjust for MTX dose due to the study design, lack of a placebo group, and low progression rate of structural damage that compromised the ability to demonstrate a benefit between the filgotinib arms compared to MTX.

Filgotinib in combination with MTX could be considered as a treatment option for patients with moderately or severely active [RA] who have limited or no previous exposure to MTX, the researchers concluded.

Disclosure: This clinical trial was supported by Gilead Sciences. Please see the original reference for a full list of authors disclosures.

Westhovens R, Rigby WFC, van der Heijde D, et al. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. Published online January 15, 2021. doi:10.1136/annrheumdis-2020-219213

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Assessing the Safety and Efficacy of Filgotinib in Combination With Methotrexate or as Monotherapy in RA - Rheumatology Advisor

NORTH CHICAGO, Ill., Jan. 25, 2021 /PRNewswire/ --AbbVie (NYSE: ABBV), today announced that the European Commission (EC) has approved RINVOQTM (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. RINVOQ is also indicated for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.1 The EC approval is supported by data from the three pivotal clinical trials SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1, demonstrating RINVOQ's efficacy across multiple measures of disease activity.* 4-6

"Psoriatic arthritis and ankylosing spondylitis have a significant impact on many aspects of life for those living with these conditions," saidTom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. "We are proud to provide RINVOQ as a new treatment option to patients with PsA and a first-in-class treatment option to those living with AS. These approvals are important milestones in our commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases."

"Psoriatic arthritis and ankylosing spondylitis are multi-faceted diseases that can cause severe pain, restricted mobility, and lasting structural damage," said Iain McInnes, Professor of Medicine and Versus Arthritis Professor of Rheumatology at University of Glasgow, UK. "In clinical trials, RINVOQ demonstrated improvements across multiple manifestations of these diseases. The approvals of RINVOQ for the treatment of PsA and AS offer physicians in the European Union an important new therapeutic option and for their patients a new opportunity to find meaningful relief from their debilitating symptoms."

In both Phase 3 clinical trials, SELECT-PsA 1 and SELECT-PsA 2, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo in adults with active PsA who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs, respectively.4,5RINVOQ also achieved non-inferiority to adalimumab# (40mg, every other week) for ACR 20 at week 12.4Patients receiving RINVOQ experienced greater improvements in physical function (as measured by HAQ-DI at week 12) and skin symptoms (as measured by PASI-75 at week 16), and a greater proportion achieved minimal disease activity (MDA) compared to those receiving placebo at week 24.4,5

RINVOQ also met the primary endpoint of Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 14 versus placebo in SELECT-AXIS 1, a Phase 2/3 study in adult patients with AS who were nave to biologic DMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).6 Additionally,RINVOQ achieved statistical significance across several multiplicity adjusted key secondary endpoints versus placebo, including ASAS partial remission (PR) at week 14 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at week 14.6

Safety results from SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1 have been previously reported and were consistent with those observed in rheumatoid arthritis, with no new significant safety risks identified.3-6 Integrated safety data for SELECT-PsA 1 and SELECT-PsA 2 through week 24 show that Serious Adverse Events occurred in 4.1% of the patients in the RINVOQ 15 mg group compared to 3.7% in the adalimumab group and 2.7% in the placebo group.7,8 The most common adverse events reported with RINVOQ 15 mg were upper respiratory tract infection, nasopharyngitis, increased blood CPK, ALT increase and AST increase.3-5 In SELECT-AXIS 1, Serious Adverse Events were reported in 1% of the patients in both the RINVOQ 15 mg and placebo group. The most common adverse events reported with RINVOQ 15 mg included blood CPK increase, diarrhea, nasopharyngitis, headache and nausea.3,6

The Marketing Authorization means that RINVOQ is approved in all member states of the European Union, as well as Iceland, Liechtenstein and Norway. RINVOQ is already approved for the treatment ofadults with moderate to severe active rheumatoid arthritis.2

About Psoriatic Arthritis and Ankylosing Spondylitis

Psoriatic arthritis and Ankylosing spondylitis are debilitating diseases that can cause severe pain, restricted mobility and lasting structural damage.9-11 Despite treatment advances, many people with AS and PsA often do not achieve their treatment goals.12,13

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including skin and joints.14 In psoriatic arthritis, the immune system creates inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.10,14

Ankylosing spondylitis is a chronic, inflammatory musculoskeletal disease primarily affecting the spine and characterized by debilitating symptoms of pain, limited mobility and structural damage.16

About SELECT-PsA 12,4

SELECT-PsA 1is a Phase 3, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg, adalimumab 40 mg EOW or placebo at baseline. At week 24, placebo patients were switched to either RINVOQ 15 mg or RINVOQ 30 mg.

The primary endpoint was the percentage of subjects receiving RINVOQ 15 mg or RINVOQ 30 mg who achieved an ACR20 response at 12 weeks of treatment versus placebo. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16 and proportion of patients achieving minimal disease activity (MDA) at week 24. These are not all of the secondary endpoints. The trial is ongoing and the long-term extension will provide data on the long-term safety, tolerability and efficacy of RINVOQ in patients who have completed the placebo-controlled period.

Top-line results from SELECT-PsA 1were previously announced in February 2020. More information on this trial can be found atwww.clinicaltrials.gov(NCT03104400).

About SELECT-PsA 22,5

SELECT-PsA 2is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one biologic (bDMARD). Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.

The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24. These are not all of the secondary endpoints. The trial is ongoing and the long-term extension will provide data on the long-term safety, tolerability and efficacy of RINVOQ in patients who have completed the placebo-controlled period.

Top-line results from SELECT-PsA 2were previously announced in October 2019. More information on this trial can be found atwww.clinicaltrials.gov(NCT03104374).

About SELECT-AXIS 12,6

SELECT-AXIS 1is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with activeankylosing spondylitis who are bDMARD-nave and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs.

Key ranked secondary endpoints included proportion of subjects achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 and ASAS partial remission (PR) at week 14, as well as change from baseline in Ankylosing Spondylitis Disease Activity Scores (ASDAS), MRI Spondyloarthritis Research Consortium ofCanada(SPARCC) score (spine) and Bath Ankylosing Spondylitis Functional Index (BASFI) at week 14. Period 2 is an open-label extension period to evaluate the long-term safety, tolerability and efficacy of RINVOQ in subjects who completed Period 1.

Results from SELECT-AXIS 1were previously announced in November 2019. More information on this trial can be found atwww.clinicaltrials.gov(NCT03178487).

About RINVOQ(upadacitinib)

Discovered and developed by AbbVie scientists,RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.3,17-27 InAugust 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. InDecember 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.17, 20-27

Important Safety Information about RINVOQ (upadacitinib)1

RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

Use in combination with other potent immunosuppressants is not recommended.

Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or travelled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients 65 years of age, caution should be used when treating this population.

Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.

Viral reactivation, including cases of herpes zoster, were reported in clinical studies. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.

The use of live, attenuated vaccines during, or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines.

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including non-melanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy.Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Absolute neutrophil count <1000 cells/mm3, absolute lymphocyte count <500cells/mm3, or haemoglobin levels <8g/dL were reported in<1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with these haematological abnormalities observed during routine patient management.

RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.

Upadacitinib treatment was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.

Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation. If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

The most commonly reported adverse drug reactions (ADRs) were upper respiratory tract infections, bronchitis, nausea, blood creatine phosphokinase (CPK) increased and cough. The most common serious adverse reactions were serious infections.

Psoriatic arthritis: Overall, the safety profile observed in patients with active psoriatic arthritis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. A higher incidence of acne and bronchitis was observed in patients treated with upadacitinib 15 mg (1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%, respectively). A higher rate of serious infections (2.6 events per 100 patientyears and 1.3 events per 100 patientyears, respectively) and hepatic transaminase elevations (ALT elevations Grade 3 and higher rates 1.4% and 0.4%, respectively) was observed in patients treated with upadacitinib in combination with MTX therapy compared to patients treated with monotherapy. There was a higher rate of serious infections in patients 65 years of age, although data are limited.

Ankylosing spondylitis: Overall, the safety profile observed in patients with active ankylosing spondylitis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. No new safety findings were identified.

Please see the full SmPC for complete prescribing information atwww.EMA.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Rheumatology

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTubeand LinkedIn.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties, including the impact of the COVID-19 pandemic on AbbVie's operations, results and financial results, that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits of the Allergan acquisition, failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the Allergan acquisition, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (SEC). AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

* Key domains include: Patient's global assessment of disease activity; Pain; Function; Inflammation# Superiority for RINVOQ 15 mg to adalimumab could not be demonstratedIn patients with 3% BSA psoriasis at baseline

References

SOURCE AbbVie

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European Commission Approves AbbVie's RINVOQ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis - PRNewswire

BY KEITH ROACH, M.D.

DEAR DR. ROACH: If I have the beginnings of arthritis of the knee, is an elliptical machine better to use than a treadmill? M.D.

ANSWER: If you had an inflammatory arthritis like rheumatoid arthritis, there are powerful medicines that can dramatically slow or stop progression of the disease. So Im going to assume you have osteoarthritis, which is by far the most common arthritis of the knee.

No treatment is known to stop the progression of osteoarthritis. But exercise is one of the most effective treatments to reduce pain and especially to increase function. This is counterintuitive to many people even many doctors are loath to prescribe exercise because for years osteoarthritis was considered a wear and tear injury of the joint. Research shows this not to be the case. Although joint injury can lead to development of osteoarthritis, regular exercise does not. Many studies have shown that a graded exercise program (starting slow and easy, and gradually building up) can lead to better function and endurance.

Unfortunately, many people with severe osteoarthritis have such pain that exercise seems impossible. People write to me that they just cant do any exercise, and indeed, it can get to the point where any movement is so painful that joint replacement becomes the only viable option. But for people with early arthritis, like you, and even moderate arthritis, exercise is a powerful tool.

Elliptical machines put less impact pressure on the joint and will be better tolerated by people with more-advanced arthritis. Pools provide the most support for your joints. However, you can do whatever exercise feels best to you. Both treadmills and elliptical machines are an investment (so is a gym membership, once the pandemic is under control), but brisk walking is cheap and effective.

DEAR DR. ROACH: In regard to your recent column on COVID-19 exposure, though it may seem logical to advise the person to avoid playing tennis that night with a contact of a COVID case, the person who was the contact was described as having not seen his son for at least one week before the diagnosis. In fact, the recommended look-back time for defining contact is 48 hours before the onset of symptoms or before a positive sample was collected in someone who is asymptomatic. According to the Centers for Disease Control and Prevention, a close contact is someone who was within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period starting from 2 days before illness onset (or, for asymptomatic patients, 2 days prior to test specimen collection) until the time the patient is isolated.

Stating that the father of the son needs to quarantine would lead to many more people quarantining than is currently recommended. Though that might truly be useful, current efforts are aimed at contacts of known cases whose exposure was within the period when the risk of transmission was most significant. M.K.

ANSWER: I appreciate Dr. M.K., who is a professor of medicine and an infectious disease specialist, for writing. I wrote my answer to be as cautious as possible, but Dr. M.K.s point is correct that the last exposure to the son was several days before the son developed symptoms and presumably several days before the son had the positive COVID test, though the submitted question implied the test was earlier than the symptoms. The father would not currently be recommended to quarantine by the CDCs guidelines. However, a person should consider their own risk of severe complications should they become infected when planning activities.

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What's best for arthritis: elliptical or treadmill? | News, Sports, Jobs - The Express - Lock Haven Express

Looking to the rheumatology space, UK-based digital health company Ampersand Healthis rolling out a new product called My Arthritis DTxto support patients with inflammatory arthropathies.

Patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis can use the tool to self-managetheir condition. It provides users with educational resources and courses, and can connect to their clinical team if their UK National Trust uses the tool. Patients can asynchronously communicatewith their care teams.

Patients using the tool can tap into cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness services. The tool also lets users track their arthritis over time, as well as monitortheir physical health, mental health and sleep.

HIMSS20 Digital

Currently, the product is in clinical trials. This marks Ampersand Health's second digital product. Its first product, My IBD Care, focuseson helping individuals with Crohn's disease or ulcerative colitis.

WHY IT MATTERS

Inflammatory arthropathies are very common. In fact, more than 54 million people in the U.S. have arthritis, according to the CDC.

The agency says that age increases the likelihood of the condition, as well as obesity. Patients can manage the condition through education programs, activities and losing weight, according to the agency.

THE LARGER TREND

Several digital health companies are working on products to support arthritis patients. In June, SidekickHealthpartnered with Pfizerto launch an appaimed at helping patients with diseases including rheumatoid arthritis manage their conditions from home. The deal is thought to be worth more than $8 million.

The interest in the space has long a history. In 2018,MyHealthTeams announced a deal to join forces with UCB to add a new spondyloarthritis social network. UCB has also worked with Garmin on a wellness program for rheumatoid arthritis patients.

Swedish startup Joint Academy raised $23 million in Series Bround of funding in September 2020 for its clinical evidence-based digital treatment for chronic joint pain, which connects patients with licensed physical therapists. Formerly calledArtho Therapeutics,its total funding raise comes to $34.2 million.

The rest is here:
UK-based Ampersand Health rolls out My Arthritis DTx - Mobihealth News

Introduction

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by persistent synovitis, systemic inflammation and the presence of autoantibodies. Uncontrolled active RA causes joint damage, disability, decreased quality of life, and cardiovascular and other comorbidities.1 Current recommendations state that therapy with disease-modifying antirheumatic drugs (DMARDs) should be started as soon as the diagnosis of RA is confirmed.2

Adherence can be defined as the process by which patients take their medications as prescribed. This process includes initiation of the drug, implementation of the prescribed regimen and discontinuation of the drug.3 Lack of adherence contributes to an inadequate response or failure to treatment, worsening or disease relapse, and unnecessary treatment changes.4 It has been stated that compliance declines over time.5 This is important because a lack of adherence to pharmacologic therapy is a prevalent issue in the treatment of chronic diseases such as RA.

Adherence has not been widely examined for most rheumatic conditions.6 The ability of physicians to recognize nonadherence is poor, and interventions to improve adherence have had mixed results.7 Currently, a gold standard for the measurement of adherence is not available.7,8 The use of patient questionnaires, an indirect method to measure adherence, is an inexpensive and useful method due to its simplicity.7 A compliance questionnaire in Rheumatology (CQR) was developed to measure compliance to treatment and to identify factors that contribute to suboptimal adherence in patients suffering from RA, polymyalgia rheumatica and gout.9 This 19-item measure has been proven to be useful to predict compliance and identify barriers that interfere with it.9,10 Recently, the Korean and the Spanish versions of CQR, sCQR, for patients with RA have been validated.11,12 They showed high reliability with good testretest results and a high predictive value suggesting that they could be used as screening instruments. In addition, the use of sCQR could also help to identify reasons for nonadherence.12

Increased knowledge of the impact of therapeutic adherence of patients with RA, and identification of possible predictors of adherence will allow to develop strategies to promote adherence. The main objective of this work was to describe the prevalence of treatment adherence in patients with RA in Spain using the sCQR. Secondary objectives were to detect possible differences in adherence in patients receiving biologic DMARDs (bDMARDs) compared to conventional DMARDS (cDMARDs) and/or glucocorticoids, in patients receiving intravenous therapies compared to other routes of administration and in patients treated in Rheumatology specific day hospitals versus polyvalent day hospitals. Another secondary objective was to identify potential predictors of adherence.

We performed an observational, cross-sectional, multicenter study in outpatient clinics of Rheumatology Departments from 41 centers in Spain.

Patients were invited to participate in the study during a routine visit to the rheumatology outpatient departments. In case of agreement, the sCQR was completed by the patient in the waiting room before seeing the rheumatologist and deposited in a box. In no case, the rheumatologist had access to the answers. If respondents did not understand any specific question or had trouble reading it, it could be read aloud to them verbatim, in any case, this would induce patients to respond in a certain way. Demographic and disease data were collected during the visit. No diagnostic or therapeutic interventions other than those required by the routine practice were performed. Available data at the moment of the visit were obtained to ensure reflecting real-world practice with no interference.

Adult patients that fulfilled the 1987 American College of Rheumatology (ACR) criteria for RA or RA diagnosis given by a rheumatologist, attending routine visits, were recruited on a consecutive basis. They had to be treated with glucocorticoids, cDMARDs (methotrexate, leflunomide, sulfasalazine, antimalarials) and/or bDMARDs (infliximab, adalimumab, etanercept, certolizumab, golimumab, tocilizumab, rituximab, abatacept) for at least 3 months and give their informed consent in order to participate in the study. Patients had to have the ability to complete the questionnaire or have someone who could help them in its completion.

To calculate sample size, results obtained in the preliminary study of the transcultural adaptation of sCQR were considered, where a 78% adherence to treatment was established.12 Estimating a similar proportion of therapeutic adherence and having in mind that the prevalence of RA in Spanish population is 0.5%13 and Spanish population is 46,439,864 inhabitants, for an alpha error of 5% and an accuracy of 3% it was estimated that the necessary sample would be 730 patients. Assuming a loss percentage of 15%, a total population of 859 patients was determined to be necessary.

To achieve a representative sample, centers were selected across the Spanish geography according to population density and public health spending. Approximately 40 centers were estimated to be necessary. At least one region was randomly selected from each of the four groups, created according to stratification criteria, depending on population and health expenditure (supplementary Figure 1).

An effort was made to include as many regions and centers in the study. In each region, second- and third-level centers participated so that the sample was as representative as possible. The geographic variability of the recruited centers also contributed to guarantee this. The established minimum number of centers being selected in each group depended on the population of each of the groups.

The compliance questionnaire in rheumatology (CQR) is a 19-item questionnaire that encompasses various aspects of adherence (Box 1). Spanish validated version was used in this study. Items indicating greater adherence (questions 13, 57, 10 and 1318) were scored from 3 to 0 (3, strongly agree; 2, agree; 1, little agreement; 0, completely disagree). Items indicating poorer adherence (questions 4, 8, 9, 11, 12 and 19) were scored from 3 to 0 (0, strongly agree; 1, agree; 2, little agreement; 3, completely disagree). To adjust its weight, a coefficient was applied to each item, to generate a Z score (ZK): ZK = a + W1X1K + W2X2K + + W19X19K, where ZK is the discriminant Z score for patient K, a is a constant, Wi is the discriminant weight for item i and patient K. A cutoff point allowed classifying patients into those with satisfactory compliance or unsatisfactory compliance.12

Box 1 Compliance Questionnaire in Rheumatology

The following data were collected: demographic data (age, sex, study level, civil status and cohabitation), data related to RA (disease duration, number of drugs used to treat RA, auxiliary drugs were not considered, eg folic acid or vitamin D, glucocorticoids use and route of administration, cDMARD use and route of administration, bDMARD use and route of administration), hospital infrastructure (specific day hospital versus polyvalent).

The study was approved by Santiago-Lugo Ethics Committee (Registry Code: 2017/296 dated 29/05/2018). All the procedures were performed in accordance with the requirements for studies involving human participants and followed the principles stated in the Declaration of Helsinki. Both informed and written consent were sought from each participant using a consent form before enrollment in the study. Survey confidentiality and anonymity were assured to all enrolled participants.

A descriptive analysis of all of the variables included in the study was performed. To identify if there were differences depending on the treatment received (bDMARDs versus cDMARDs), its route of administration or the area of origin, Chi2 was used. Likewise, in order to identify adherence predictive factors, a univariate and multivariate linear regression study adjusted for significant variables and for age and sex variables was performed. Values of statistical significance were considered at p < 0.05. In the regression analysis, the categorical variables included were the number of medications the patient was taking, steroid use, use of cDMARDs, routes of administration of cDMARDs, use of bDMARDs, routes of administration of bDMARDs, health area, sex, level education, marital status and cohabitation. Continuous variables included in the regression analysis were the age and disease duration. For the statistical analysis, Stata version14.0 (Stata/MP14.0 for Windows; StataCorpLP, College Station, TX) was used.

A total of 859 patients contributed by 41 centers were selected and included in the study. All patients answered the questionnaire, 729 patients completed the 19 items and 130 skipped at least one of them. For analysis purposes, we considered patients who completed the 19 items. Baseline patient characteristics are shown in Table 1. A total of 418 patients (48.7%) were being treated with bDMARDs and 682 (79.3%) were receiving cDMARDs. Five hundred and sixty-five patients (65.8%) were receiving more than one drug for the treatment of RA (glucocorticoids, cDMARDs and/or bDMARDs) at the time they filled the questionnaire.

Table 1 Baseline Characteristics of Patients

An adherence rate of 79.01% was established. As for the secondary objectives, no differences were determined in adherence among patients related to the type of drugs they were receiving, bDMARDs versus cDMARDs (p = 0.1442), among patients receiving intravenous therapies versus other routes of administration (p = 0.7453) and among patients treated in specific day hospitals versus polyvalent day hospitals (p = 2.6815). The use of bDMARD combined with cDMARD also showed no difference in adherence compared to bDMARD monotherapy administration (p=0.314).

The univariate analysis detected the number of drugs and cohabitation as predictors of adherence to treatment (Table 2). When performing the multivariate analysis adjusted for sex and age, the same two variables remained as predictors of adherence, determining that both, number of drugs and cohabitation, are independent predictors of adherence.

Table 2 Association of Study Variables with Treatment Adherence

To test for sensitivity, the same statistical analysis was performed including all of the 859 patients, without ruling out the patients who skipped questionnaire items, considering these patients as non-adherents. The univariate analysis detected the same variables, number of drugs and cohabitation, as predictors of adherence to treatment (supplementary table 1). Civil status and age were also significant. Multivariate analysis adjusted for sex and age confirmed the number of drugs as an independent predictor of adherence.

Finally, ANOVA analysis was performed to test for sex and age influence on adherence and no statistical significance was detected.

This study conducted in Spanish population shows that adherence to treatment occurred in 79% of patients with RA. Multivariate analysis, adjusted for age and sex, revealed that a number of drugs and cohabitation were independently associated with adherence in this population.

There are currently different methods to assess medication adherence. A lack of consensus exists when determining which is the best instrument.14 This study was conducted using a highly reliable and specific tool, being the only rheumatology-specific adherence measure,8,9 that has been recently validated for its use in Spanish RA population.12 It must also be stressed the special effort that was made when selecting centers to participate in the study, having into account geographical distribution and other variables, such as population density and public health expenditure for each region, in order to obtain a representative sample of Spain. Results obtained in this study can be extrapolated to the total Spanish population.

The adherence rate of 79% detected in this study is similar to rates observed in previous studies performed in Spanish population where an adherence of 79% was detected for patients being treated with oral antirheumatic drugs15 and 85% in the case of SC bDMARDs.16 Reported adherence rates in literature are highly variable, ranging from 30% to 80%.8 A systematic review of the literature estimated a 66% adherence to medication in patients with RA.17 Different definitions, methods, treatments and populations are behind this variability making it difficult to determine the magnitude of the problem. Optimal adherence depends on the type of drug and it remains to be determined in RA, if we understand optimal adherence as the relation between adherence level and disease flare. Independently of the definition of optimal adherence, we must be ambitious and try to ensure that patients follow treatment instructions rigorously. Nonetheless, adherence to treatment in RA patients is still suboptimal.8

The type of treatment did not determine the adherence rate in our study. No differences were detected in adherence among patients receiving bDMARDs versus cDMARDS and/or glucocorticoids. To our knowledge, this is the first study that studies the relationship between the type of therapy used to treat RA and adherence.

Our findings suggest that route of administration does not have an impact on adherence. This is in line with what has been shown in previous studies, where adherence and persistence rates appeared broadly similar for the different routes of drug administration in RA.18

The multivariate analyses determined that the number of drugs was an independent predictor of adherence. This fact is especially relevant, considering that treatment strategies in patients with RA rely heavily on the combined use of steroids, cDMARDs and bDMARDs. Contradictory results related to the impact of the number of medications on adherence have been reported.1922 Regimen complexity (multiple medications, multiple doses, specific dietary or time requirements) has been related to poorer adherence in chronic diseases.23 Less frequent dosing has been related to better compliance.5,16 Simpler, more convenient dosing regimens resulted in better compliance.24 Since using complex regimens requires a good communication between doctor and patient, patients have to understand the consequences of not following the instructions correctly. Prescription needs to be a shared decision process, in order to achieve a consensus. Patient empowerment may have a positive effect on adherence; however, highly empowered patients might believe that they can make treatment decisions. Intelligent non-adherence is becoming a common term. Patients have to be properly informed.

The second independent predictor of adherence in this study was the cohabitation status. Living alone has been previously associated with poor adherence.25,26 Social support seems to be an important factor contributing to proper compliance. Family support has been related to an improvement in adherence to bDMARD in RA.27

Duration of disease, civil status, education level, sex and age were not identified as predictors of adherence. These findings are in line with previous reports in which no evidence for any association with adherence was determined.14

The study has several limitations. The study design, being cross-sectional, has to be considered. Adherence is not stable over time, having a dynamic nature.8 To address this issue, the inclusion of patients was not determined by disease duration so that patients in different stages of disease were included (Table 2). Patients had to be treated for at least 3 months but no upper limit on treatment duration was established. Disease activity was not measured and this variable may have an impact on adherence. Study population was not selected based on disease activity, participants reflected real-life RA population treated in routine clinical practice. Another disadvantage is the use of a self-reported questionnaire to test for adherence, even though it is a highly specific method with a highly predictive value,12 this method is relatively insensitive, since patients may claim to be adherent to avoid caregiver disapproval.8 Despite this, the use of indirect methods as the one used in this study is a more simple and feasible way to evaluate adherence and due to its highly predictive value, it can be used as a screening instrument.12

Increased knowledge of the impact of therapeutic compliance on patients with RA, and the identification of possible predictors of adherence to treatment allows to develop strategies to favor adherence to treatments and avoid problems arising from lack thereof. In any case, prescription needs to be a shared decision process where clinicians and patients can discuss their concerns and expectations, in order to achieve a consensus that will favor adherence to treatment.

Alegre Sancho JJ, Almodovar Gonzalez R, Barbazan Alvarez C, Bernad Pineda M, Blanco Alonso R, Blanco Madrigal JM, Caliz Caliz R, Calvo Alen J, Calvo Catala J, Carrasco Cubero C, Castao Sanchez M, Chamizo Carmona E, De Toro Santos FJ, Delgado Beltran C, Eges Dubuc A, Escudero Contreras A, Fernandez Nebro A, Gamero Ruiz F, Garcia Aparicio A, Hernandez Cruz B, Guerra Vazquez JL, Hernandez Miguel MV, Lopez Lasanta M, Marenco de la Fuente JL, Muoz Fernandez Santiago, Navarro Blasco FJ, Nolla Sole JM, Ornilla Laraundogoitia E, Ortiz Garcia A, Pablos Alvarez JL, Perez Esteban S, Perez Garcia C, Roman Ivorra J, Romero Yuste S, Rosello Pardo R, Salvador Alarcon G, Tornero Molina J, Urruticoechea Arana A, Vela Casasempere P.

This study was financed by Roche Farma S.A. Spain.

Dr Manuel Pombo-Suarez reports grants from Roche Farma S.A. Spain, during the conduct of the study. The authors report no other conflicts of interest in this work.

1. Scott DL, Wolfe FHT. Rheumatoid Arthritis. Lancet. 2010;376:10941108.

2. Smolen JS, Landew R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76:960977. doi:10.1136/annrheumdis-2016-210715

3. Vrijens B, De Geest S, Hughes DA, et al. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012;73:691705. doi:10.1111/j.1365-2125.2012.04167.x

4. Shafrin J, Bognar K, Everson K, Brauer M, Lakdawalla DN, Forma FM. Does knowledge of patient non-compliance change prescribing behavior in the real world? A claims-based analysis of patients with serious mental illness. Clin Outcomes Res. 2018;Volume 10:573585. doi:10.2147/CEOR.S175877

5. De Klerk E, Van der Heijde D, Landew R, Van der Tempel H, Urquhart J, Van der Linden S. Patient compliance in rheumatoid arthritis, polymyalgia rheumatica, and gout. J Rheumatol. 2003.

6. Harrold LR, Andrade SE. Medication adherence of patients with selected rheumatic conditions: a systematic review of the literature. Semin Arthritis Rheum. 2009;38:396402. doi:10.1016/j.semarthrit.2008.01.011

7. Osterberg L, Blaschke T. Drug therapy: adherence to medication. N Engl J Med. 2005;353:487497. doi:10.1056/NEJMra050100

8. Van Den Bemt BJF, Zwikker HE, Van Den Ende CHM. Medication adherence in patients with rheumatoid arthritis: A critical appraisal of the existing literature. Expert Rev Clin Immunol. 2012;8:337351. doi:10.1586/eci.12.23

9. De Klerk E, Van Der Heijde D, Van Der Tempel H, Van Der Linden S. Development of a questionnaire to investigate patient compliance with antirheumatic drug therapy. J Rheumatol. 1999.

10. De Klerk E, Van Der Heijde D, Landew R, Van Der Tempel H, Van Der Linden S. The compliance-questionnaire-rheumatology compared with electronic medication event monitoring: a validation study. J Rheumatol. 2003.

11. Lee JY, Lee SY, Hahn HJ, Son IJ, Hahn SG, Lee EB. Cultural adaptation of a compliance questionnaire for patients with rheumatoid arthritis to a korean version. Korean J Intern Med. 2011;26:28. doi:10.3904/kjim.2011.26.1.28

12. Salgado E, Fernndez JRM, Vilas AS, Gmez-Reino JJ. Spanish transcultural adaptation and validation of the English version of the compliance questionnaire in rheumatology. Rheumatol Int. 2018. doi:10.1007/s00296-018-3930-7

13. Carmona L. The prevalence of rheumatoid arthritis in the general population of Spain. Rheumatology. 2002;41:8895. doi:10.1093/rheumatology/41.1.88

14. Pasma A, Vant Spijker A, Hazes JMW, Busschbach JJV, Luime JJ. Factors associated with adherence to pharmaceutical treatment for rheumatoid arthritis patients: A systematic review. Semin Arthritis Rheum. 2013;43:1828. doi:10.1016/j.semarthrit.2012.12.001

15. Marras C, Monteagudo I, Salvador G, et al. Identification of patients at risk of non-adherence to oral antirheumatic drugs in rheumatoid arthritis using the Compliance Questionnaire in Rheumatology: an ARCO sub-study. Rheumatol Int. 2017;37:11951202. doi:10.1007/s00296-017-3737-y

16. Calvo-Aln J, Monteagudo I, Salvador G, et al. Non-adherence to subcutaneous biological medication in patients with rheumatoid arthritis: A multicentre, non-interventional study. Clin Exp Rheumatol. 2017.

17. Scheiman-Elazary A, Duan L, Shourt C, et al. The rate of adherence to antiarthritis medications and associated factors among patients with rheumatoid arthritis: A systematic literature review and metaanalysis. J Rheumatol. 2016;43:512523. doi:10.3899/jrheum.141371

18. Fautrel B, Balsa A, Van Riel P, et al. Influence of route of administration/drug formulation and other factors on adherence to treatment in rheumatoid arthritis (pain related) and dyslipidemia (non-pain related). Curr Med Res Opin. 2017;33:12311246. doi:10.1080/03007995.2017.1313209

19. Treharne GJ, Lyons AC, Kitas GD. Medication adherence in rheumatoid arthritis: effects of psychosocial factors. Psychol Heal Med. 2004;9:337349. doi:10.1080/13548500410001721909

20. Van Den Bemt BJF, Van Den Hoogen FHJ, Benraad B, Hekster YA, Van Riel PLCM, Van Lankveld W. Adherence rates and associations with nonadherence in patients with rheumatoid arthritis using disease modifying antirheumatic drugs. J Rheumatol. 2009;36:21642170. doi:10.3899/jrheum.081204

21. Park DC, Hertzog C, Leventhal H, et al. Medication adherence in rheumatoid arthritis patients: older is wiser. J Am Geriatr Soc. 1999;47:172183. doi:10.1111/j.1532-5415.1999.tb04575.x

22. Kristensen LE, Saxne T, Nilsson J, Geborek P. Impact of concomitant DMARD therapy on adherence to treatment with etanercept and infliximab in rheumatoid arthritis. Results from a six-year observational study in southern Sweden. Arthritis Res Ther. 2006;54:600606. doi:10.1186/ar2084

23. Ingersoll KS, Cohen J. The impact of medication regimen factors on adherence to chronic treatment: A review of literature. J Behav Med. 2008;31:213224. doi:10.1007/s10865-007-9147-y

24. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23:12961310. doi:10.1016/S0149-2918(01)80109-0

25. Lorish CD, Richards B, Brown S. Missed medication doses in rheumatic arthritis patients: intentional and unintentional reasons. Arthritis Care Res. 1989;2:39. doi:10.1002/anr.1790020103

26. De Cuyper E, De Gucht V, Maes S, Van Camp Y, De Clerck LS. Determinants of methotrexate adherence in rheumatoid arthritis patients. Clin Rheumatol. 2016;35:13351339. doi:10.1007/s10067-016-3182-4

27. Morgan C, McBeth J, Cordingley L, et al. The influence of behavioural and psychological factors on medication adherence over time in rheumatoid arthritis patients: A study in the biologics era. Rheumatol. 2015. doi:10.1093/rheumatology/kev105

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[Full text] Adherence to Treatment in Patients with Rheumatoid Arthritis from Spai | PPA - Dove Medical Press

Introduction:Region-specific health-related quality of life (HRQoL) scores or utility values are representative and pivotal for economic evaluations as they are influenced by the value judgment of the local population. This study systematically reviewed and pooled EuroQoL-5 Dimension (EQ-5D) utility scores of rheumatoid arthritis (RA) across primary studies from Asia.

Methods:Studies reporting EQ-5D utility scores among adult RA patients from Asian countries were systematically searched in PubMed-Medline, Scopus and Embase since inception through February 2020. Selected studies were systematically reviewed and study quality assessment was performed. Meta-analysis was performed using a random-effect model with subgroup and meta-regression analysis to explore heterogeneity.

Results:Among 1391 searched articles, 37 studies with 31 983 participants were systematically reviewed and meta-analysis was conducted among 31 studies. The pooled EQ-5D scores and EQ-5D visual analog score were 0.66 (95% CI 0.63-0.69, I2= 99.65%) and 61.21 (50.73-71.69, I2= 99.56%) respectively with high heterogeneity. For RA patients with no, low, moderate and high disease activity based on Disease Activity Score (DAS)-28, the pooled EQ-5D scores were 0.78 (0.65-0.90), 0.73 (0.65-0.80), 0.53 (0.32- 0.74), and 0.47 (0.32-0.62), respectively. On meta-regression, age of patients (P < .05) was positively associated and use of glucocorticoids (P < .05) was inversely associated with utility values.

Conclusion:Lower EQ-5D scores were associated with severe disease activity, increasing age and female gender among RA patients. The study provides pooled EQ-5D scores for RA patients that are useful inputs for cost-utility studies in Asia.

Keywords:EQ-5D-3L health utility; EQ-5D-5L; rheumatoid arthritis.

Link:
Health-related quality of life in rheumatoid arthritis: Systematic review and meta-analysis of EuroQoL (EQ-5D) utility scores from Asia - DocWire News