StemCell Therapy

When I was a little girl, I had high-flying dreams and they had very little to do with my juvenile arthritis, a childhood illness similar to rheumatoid arthritis (RA). First, I wanted to be a ballerina and practiced dance moves on my parents' Persian rug. Then I watched Jacques Cousteau and his crew of marine biologists diving in waters all over the world and scuttled the dancing dream in favor of serving on his ship, the Calypso, and spending much of my life under water. But at age 16, I went home after a two-year hospital stay in a power wheelchair, trailing recommendations from my then-medical team to lower my expectations of life to those resembling a turnip's. Because of the disease, y'know.

It would be easy to dismiss this as a function of attitudes in a land and time far away from now. But these perceptions persist, if not in others, then certainly in ourselves. Its a strange thing, this shift in assumption and expectation. The minute you get a diagnosis of chronic illness, its as if the rug is pulled out from under you. Your future, which had just shone with possibility, now seems dull, hopeless, and framed in less-than.

Do you really have to give it all up and accept a life of sitting on the sidelines? No. Not by a long shot. The key is to adapt and change your approach. But more on that in a bit. First, lets take a look at the obstacles.

I've lived with RA for more than half a century and have learned that the only predictable thing about this condition is that you never know what it'll do next. Sometimes, you're lucky and find a medication that works, suppressing the symptoms so you can get back to your life. At other times, its all you can do to get dressed in the morning. And, of course, all the stages in between.

Fifty years ago, an American psychologist by the name of Martin Seligman did a study that led to a classic theory of depression. He divided dogs into two groups. Both would receive shocks, but one group of dogs would be able to escape, the other not. The dogs that had no control over the situation curled up in a ball, whimpering. Seligman developed a theory called learned helplessness, stating that when people have no agency (that is, no control), they are more likely to develop depression.

When you have no ability to predict how your RA will feel in the morningand therefore what you will be able to doyou can feel helpless. If youre feeling that kind of helplessness for weeks or months, it spreads into other areas of your life, making you feel depressed. It may even be accompanied by its bratty cousin, "Feel Like Giving Up." And that's OK. Because RA affects every part of your life and it's hard to re-learn how to be you. There's nothing wrong with having a moment (or 10) of intense frustration. But what's really important is to make sure it doesn't stick around.

So much of living with RA is about kicking that cousin out of your psyche. Again, your doctor can help, as can therapy, family and friends, and a community of others like you. Having support will help you fight back and find other ways of taking up the reins of your life.

The great thing about life is that there is no one way to do anything. Whether it's opening a jar, having a family, or building your own business, there are ways around that big boulder called RA in the middle of your path. These tips can help:

Talk to your doctor. Your rheumatologist is one of the most important members on your team. If your RA is getting in the way of you creating a life, call them. You might need to adjust your treatment so you can start the journey back to living first, with RA just muttering in the background. Many people also include diet, exercise, supplements, and alternative treatments in how they approach living with RA.

Give yourself extra time to achieve your goals. Maybe your RA diagnosis won't require a complete change in direction for your life. You might be able to stay on your current career path or even keep training for that big race you've been wanting to tackle, but it's probably going to take a little extra time to get there. Getting the right treatment working for you can take time, and flares don't respect your "to-do" list.

Don't expect to follow "normal" timelines when it comes to working toward big goalsRA is bound to get in the way. When it comes to dreams, pursuing them is what matters, not how you go about it. You are free to create your own path, one that respects and accommodates your RA. For instance, I used to work as a policy analyst, frequently working from home four days a week on research and writing tasks. This enabled me to work much more effectively, with fewer sick days.

When RA brings physical limitations, use your mental muscle instead. I will forever be grateful to my parents for the way they dealt with the lost teenager who came home from the hospital. They told me that although my body might not work very well, there was nothing wrong with my mind and they expected me to use it. This meant working hard in school so I could get to college. By then, I had realized the importance of focusing on what I was able to do (and not just because I couldn't swim, so working with Cousteau was a wash).

Finding alternate routes to getting where I wanted to go eventually became a bit of a hobby and by now, I can almost always find a way around an obstacle. Remember that although your condition might get in the way of you becoming a trapeze artist, you can absolutely find another way to be in the circus.

Go easy on yourself, but not too easy. Frustration about struggling with RA might get misdirected toward yourself. Try not to be angry at yourself or your body. It'll get you nowhere, except derailed, and it isnt something you would tolerate for anyone else. Be kind and understanding to yourself.

Human beings have a gift of adaptation, being able to live in almost any climate, under any conditions, and changing their approach to survive. Use that gift to create your life. Yes, with RA, but a life in which you tear down limits of low expectations.

Following your dreams is a process, sometimes a long one, with side tracks and pauses, and often infuriatingly so. But persevering, accommodating your own needs to move slower, to take pauses, but then reassessing and getting back to your path is possible. The only way to live with RA is to become as stubborn as a goat and refuse to stay down. You learn to withstand long periods of having to put your dream (and your life) on hold while you deal with your condition and its nonsense. During those times of flares and pain, you hone a single-minded focus by getting through each day. When it is over, when you are better and get your life back, you use that focus to pick up your dream and work on it some more.

After many years of attending university, with many challenges, I graduated with my masters degree in social work. After immigrating to Canada from Denmark, and with the offer of a government job in human rights, I thought of those doctors who'd had zero expectations of the girl with a chronic illness and disability. In that moment, I wanted very much to write them a letter, telling them how their assumptions of my inability had had the exact opposite effect: They had only spurred me on.

In my family, that's called the "Show the Bastards" gene. I'll bet you have one, too.

Read this article:
Rheumatoid Arthritis Will Change Your Life. It Doesn't Have to Ruin It. - HealthCentral.com

Genetics and weather are coming against Newfoundlanders and Labradorians who have the highest incidence of arthritis in Canada.

One in four Newfoundlanders and Labradorians suffer from one form of arthritis or another.

That from the Arthritis Societys Jennifer Henning. She says arthritis is an inflammation of the joint, but there are some 100 different types of the disease which is split into two major categories, inflammatory and degenerative.

Rheumatoid arthritis is an autoimmune attack on the joints by the bodys own immune system. It can happen at any time, and affect the entire body.

Osteoarthritis is the most common form and comes as the result of wear and tear, injury or the general aging process. It involves a degeneration of the cartilage between the bones of the joint.

Both types of arthritis result in significant pain and loss of mobility.

Henning says unfortunately, weather doesnt help.

She says in laymans terms, the body is tighter because its cold, and when its wet the tissues swell, causing a greater amount of pain and inflammation.

She says genetics also play a strong role especially in the inflammatory type of arthritis.

Rheumatoid arthritis is more common in women and is often triggered by a traumatic event like childbirth, injury or illness.

Originally posted here:
Genetics and Weather in NL Producing Highest Incidence of Arthritis in Canada - VOCM

Dear Doctor: Im a 66-year-old man whose right knee really hurts from arthritis. My sister keeps talking about something called prolotherapy. What is it, and can it help?

Dear Reader: Prolotherapy is an injection-based approach to treating pain in the soft tissues of the joint. Specifically, a small amount of a liquid irritant is introduced at the site where a tendon or ligament attaches to the bone. The idea is that the irritant will set off a localized inflammation reaction, which will then trigger the release of growth factors that promote the healing of soft tissues.

The roots of prolotherapy date back to the ancient Greeks, who believed that deliberately causing inflammation in a certain area of the body could stimulate the tissues to repair themselves. In the 1930s and 1940s, several physicians expanded on the concept. They experimented with various solutions and developed techniques sometimes referred to as needle surgery to target connective tissue in the joints.

Today, prolotherapy injections typically consist of sugar- or salt-based solutions to which a local anesthetic, such as lidocaine, is added. Patients seek the treatment to help with joint pain and stiffness resulting from injury, overuse or inflammatory conditions such as arthritis and degenerative disc disease. Areas of the body targeted by the practice include the knees, back, hips, ankles, shoulders and hands.

Treatment protocols usually consist of a series of three to eight injections given over weeks or months, depending on the specific case. The injections can be moderately painful, and patients often use Tylenol or stronger medications to manage localized aches and tenderness. Patients are advised to limit activity for several days after each injection, and they may be asked to supplement the therapy with specific exercises that focus on range of motion.

Since creating inflammation is the point of prolotherapy, the use of NSAIDs, or non-steroidal anti-inflammatories, to address the resulting pain and discomfort is not recommended. Possible side effects of the procedure include bleeding, bruising or swelling at the injection site. These can last for a week or more. Allergic reactions to the injected solution, infection and nerve damage are possible, but rare.

Does prolotherapy work? In some case studies, patients report improvement in pain and strength in the affected areas. But studies of the treatment have yielded mixed results. Some have argued that the studies showing benefit have been too small and not scientifically rigorous. The one area of agreement appears to be the need for large and scientifically rigorous studies.

Although prolotherapy is gaining in popularity, the National Institutes of Health identify it as a complementary and alternative medical treatment. And since its considered an experimental therapy, many insurance companies wont cover it. Costs can range from $400 to $1,000 per treatment, depending on the provider.

As with all alternative therapies, we think its wise for you to check with your doctor to see whether prolotherapy may be helpful for you.

Send your questions to askthedoctors@mednet.ucla.edu.

Originally posted here:
Ask the doctors: Arthritis pain may be relieved by prolotherapy - The Spokesman-Review

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Arthritis treatment safe for cats with kidney disease [Ask the Vet's Pets] - Reading Eagle

Millions of patients in England will be stopped from having an X-ray on their sore back, hernia repair surgery or scan of their knee to detect arthritis under controversial plans from NHS and doctors to ration unnecessary treatment.

The Guardian has seen a list of 34 diagnostic tests and treatments that in future patients will only be able to get in exceptional circumstances as part of a drive to save money and relieve the pressure on the NHS.

The sweeping changes they are set to propose include many forms of surgery, as well as ways of detecting illness including CT and MRI scans, and blood tests, for cancer, arthritis, back problems, kidney stones, sinus infections and depression. Three of the procedures have since been dropped from the list.

If implemented, the clampdown would involve an unprecedentedly radical restriction on patients right to access and doctors ability to recommend procedures, some of which have been used routinely for decades.

It would also see patients told to use physiotherapy or painkillers to dull the pain of an arthritic knee rather than undergo an exploratory operation called an arthroscopy. Kidney stones would no longer be removed in an operating theatre and instead would be treated with sound wave therapy to reduce the pain.

Similarly, in future adenoids would not be removed because evidence now shows that it is not necessary, doesnt work well and can cause problems like bleeding and infection, according to the rationale set out in the document for curtailing that procedure.

Disclosure of the list prompted fears that the move amounts to a major escalation of NHS rationing.

An NHS spokesperson said the document was out of date and had not been approved or implemented. They added there was strong support from senior doctors in the Academy of Medical Royal Colleges for action to eliminate wasteful interventions that dont benefit patients.

The Patients Association warned that if implemented the changes would force patients to either endure the pain of their condition or pay for private care to tackle it.

Putting barriers in the way of people expecting to have so many previously commonplace tests and treatments would lead to harm and distress, said Rachel Power, the associations chief executive.

Patients have seen the range of treatments offered by the NHS cut back over recent years, and the NHS has been upfront about this being to save cash. Often there are good reasons for not using these low value treatments as a first choice, but they are appropriate for some patients.

We are unhappy at any new barriers being erected between patients and the treatments they need.

This is of a piece with the restrictions on prescribing over the counter medicines [which NHS England brought in last year], and patients have told us of the harm and distress this broad programme of restrictions has caused them, she added.

As a result of this rationing, we know that patients who can afford to pay privately are doing so, while those who cant are going without and suffering. This is exactly what having an NHS is supposed to prevent.

The 50-page document is the result of months of detailed and until now secret discussions between four key medical and NHS bodies involved in the NHSs evidence-based interventions programme, which aims to identify procedures that do not work.

They are NHS England; the Academy of Medical Royal Colleges (AOMRC), which represents the UKs 220,000 doctors professionally; NHS Clinical Commissioners, which speaks for GP-led clinical commissioning groups; and the National Institute for Health and Care Excellence (Nice), which advises the government and NHS which treatments are effective and represent value for money.

They believe many of the interventions should be scrapped, or at most used very sparingly, because they could make patients anxious or even put them in danger. For example, they are suggesting that the prostate-specific antigen test, which is used to detect prostate cancer the commonest form of cancer in men is used much less often.

The document says: Blood tests to check your prostate are not needed except for very specific cases. Blood tests can lead to further investigation that may also be unnecessary and can cause anxiety.

The four medical bodies planned to put the proposals out to public consultation this month but had to delay because of general election purdah rules.

Hospitals would be told not to operate on patients to try to slow the progress of osteoporosis (brittle bone disease), or if they have sinusitis, or to remove a disc from the spine of someone suffering from crippling pain.

Dr Richard Vautrey, chair of the British Medical Associations GPs committee, said any changes should be based on the best available evidence and not cost-cutting.

In the current climate, NHS resources must be used wisely but any restriction on treatments must be based on up to date clinical evidence and not solely on cost.

Doctors must always be able to provide the best care possible and use their clinical expertise to refer patients for the most appropriate treatments when that is needed.

Prof Carrie MacEwan, chair of the AOMRC, defended the planned restrictions. Medicine continually evolves and its right that we dont carry out tests, treatments or procedures when the evidence tells us they are inappropriate or ineffective and which, in some cases, can do more harm than good.

The list is drawn up by medical experts and senior specialist clinicians who have reviewed the latest evidence from around the world and its absolutely right we act on that evidence in the best interests of patients and so that we can focus our resources on things that we know do work, she added.

Read more:
Revealed: NHS plans to ration 34 everyday tests and treatments - The Guardian

A new discontinuation strategy for infliximab in patients with rheumatoid arthritis, in which the biologic dose was determined by the serum level of tumor necrosis factor (TNF)-, was unsuccessful for sustained biologic-free remission, say researchers recently writing in Annals of the Rheumatic Diseases.

It is well known that proinflammatory cytokines such as TNF- play central roles in the occurrence and progression of rheumatoid arthritis. As the therapeutic effects of infliximab, an inhibitor of TNF-, plus methotrexate have been demonstrated in several clinical studies, the goal of rheumatoid arthritis treatment has expanded from the achievement of clinical remission to sustained remission without biological disease-modifying antirheumatic drugs (bDMARDs), out of concern for adverse events or treatment cost. Several studies have suggested that few patients with established rheumatoid arthritis can discontinue bDMARDs without losing remission, while those in sustained deep remission are more likely to be able to discontinue bDMARDs. Moreover, a significant interaction has been demonstrated between the infliximab dose and TNF- level in the clinical response, suggesting that serum levels of TNF- could be a key indicator for optimal dosing of infliximab to achieve a clinical remission and a sustained discontinuation of infliximab for the treatment of rheumatoid arthritis. However, this hypothesis has not been confirmed in a randomized controlled trial.

The aim of this study is to determine whether the programmed infliximab treatment strategy (for which the dose of infliximab was adjusted based on the baseline serum TNF-) is beneficial to induction of clinical remission after 54 weeks and sustained discontinuation of infliximab for oneyear, wrote the authors of the study, led by Yoshiya Tanaka, M.D., Ph.D., of the University of Occupational and Environmental Health in Kitakyushu, Japan.

This multicenter trial, dubbed RRRR, included 337 patients with infliximab-nave rheumatoid arthritis with inadequate response to methotrexate. Participants were randomized to receive either the programmed treatment of 3mg/kg infliximab until week six and after 14 weeks the dose of infliximab was adjusted based on the baseline levels of serum TNF- until week 54, or standard treatment with 3mg/kg of infliximab. Patients who achieved a simplified disease activity index (SDAI) 3.3 at week 54 discontinued infliximab. The primary endpoint was the proportion of patients who sustained discontinuation of infliximab at week 106.

At week 54, 39.4 percent of the programmed group and 32.3 percent the standard group attained remission (SDAI 3.3). At week 106, the one-year sustained discontinuation rate was 23.5 percent and 21.6 percent, respectively, representing a nonsignificant 2.2 percent difference (95%CI 6.6 percentto 11.0 percent; p=0.631).

In both arms, baseline SDAI <26 was a statistically significant predictor of sustained discontinuation at one year (OR=2.97 in the programmed arm and 2.83 in the standard arm), the authors wrote. This exploratory analysis implies that the success of sustained discontinuation of infliximab depends on disease activity at baseline, and that sufficient disease control by adequate dose ofmethotrexate is required before infliximab is administered.

There was no statistically significant difference in the proportion of deep remission (DAS28 <2.2), at the last administration of infliximab between the groups, which could result in failure of sustained discontinuation of infliximab. Still, the incidence rates of infections and other safety signals were comparable between the groups, suggesting that dose escalation was tolerated in the study.

Thus, the fine tuning of infliximab-dose based on serum levels of TNF represents a key factor for achievement of remission defined by SDAI and DAS28-ESR, but may not be related to deep remission.

If serum levels of rheumatoid factor are less than 45, serum levels of TNF- are higher than 1.65, or disease activity is controlled with less than 10mg/kg of methotrexate, standard treatment may be intense enough to achieve successful discontinuation of infliximab, the authors wrote.

In order to facilitate decision-making bypatients and rheumatologists, the authors suggested that more effort is needed to determine the patient profile most likely to benefit from discontinuation of bDMARDs.

"Taken together, the findings of the RRRR study (Remission induction by Raising the dose of Remicade in RA) reveal that the programmed treatment strategy using different doses of infliximab based on the baseline levels of serum TNF- did not increase the sustained remission rate 1year after withdrawal of infliximab treatment at week 106. However, in order to facilitate decision-making by patients and rheumatologists, more efforts are needed to determine the patient profile most likely to benefit from discontinuation of biological DMARDs," the authors wrote.

REFERENCE

Yoshiya Tanaka, Koji Oba, Takao Koike, et al. Sustained discontinuation of infliximab with a raising-dose strategy after obtaining remission in patients with rheumatoid arthritis: the RRRR study, a randomised controlled trial. Annals of the Rheumatic Diseases. October 19, 2019. doi: 10.1136/annrheumdis-2019-216169

Read this article:
Sustained Remission in RA Fails with Programmed Infliximab Treatment - Rheumatology Network

(Photo : pixabay)

Theresearchprovided by the Oregon State University provided the first complete cellular-level look at what goes on in joints that are affected by osteoarthritis, which is considered as a costly and debilitating condition that affects almost one-quarter of adults in America.

The study was published inNature Biomedical Engineering, and it gave an insight into how factors like drugs, diet, and exercise can affect the joint's cells, which is important because cells do the work of maintaining, developing and repairing the tissue.

Arthritis treatment

Theresearchdone by the OSU College of Engineering's Brian Bay and the scientists from the Royal Veterinary College in London and University College London created a sophisticated scanning technique to view joints of mice that have arthritis and joints of healthy mice.

Brian Bay said that the techniques for quantifying changes in arthritic joints had been constrained by a lot of factors. Restrictions on the length of scanning time and the sample size are two of them, and the level of radiation used in some of the techniques ultimately damages or destroys the samples that are being scanned. The nanoscale resolution of intact, loaded joints had been considered unattainable.

Brain Bay and scientists from 3Dmagination Ltd, the University of Manchester, Edinburgh Napier University, the Diamond Light Source, and the Research Complex at Harwell created a way to conduct nanoscale by capturing the images of bones and whole joints under precisely controlled loads.

The scientists enhanced the resolution without compromising the study's field of view, decrease the total radiation exposure to preserve the tissue mechanics, and to prevent movement during the scanning.

Brian Bay stated that with a low-dose of pink-beam synchrotron X-ray tomography and mechanical loading with nanometric precision, scientists could measure the structural organization simultaneously and functional response of the tissues. That means that scientists can look at the joints of the patient from the tissue layers down to the cellular level with a large field of view and high resolution without having to cut out the samples.

He also stated that the two features of the study make it helpful in advancing the study of osteoarthritis. By using intact joints and bones, all of the functional aspects of the complex tissue that is layering are preserved. The small size of the mouse bones leads to imaging that is seen on the scale of the cells that maintain, develop, and repair the tissues.

The effect of osteoarthritis on health

Osteoarthritis is the degeneration of joints, and according to the Centers for Disease Control and Prevention, it affects more than50 million American adults. Around 18% of men and 25% of women suffer from osteoarthritis.

As the senior population in America increases, the prevalence of arthritis will likely rise in the coming years. The CDC estimates that by 2040 there will be 78 million arthritis patients, more than one-quarter of the projected total adult population, two-thirds of those with arthritis are expected to be women. By 2040, 34 million adults in America will have limits in the activities that they do because of arthritis.

Brian Bay said that osteoarthritis will affect most of the adults during their lifetime to the point where a hip joint or a knee joint needs replacement with a difficult and costly surgery after years of pain and disability. This new treatment that OSU has to develop can prevent any severe arthritis from forming that could save millions of adults from having to go through the difficulties of arthritis.

See more here:
Oregon State University Has Provided a New Treatment for Athritis - Science Times

Despite recent advances in the treatment of rheumatoid arthritis(RA) attributed to biologic medications, only a minority of patients achieve andmaintain disease remission without the need for continuous immunosuppressive therapy.1Complicating the treatment of RA further is the development of tolerance over timeor failure of patients to respond to currently available therapies.1Thus, the development of new treatment strategies for RA remains a priority.

Nanotherapies for RA have received increasing attention in the past decade because they offer several potential advantages compared with conventional systemic therapies.2 Nanocarriers are submicron transport particles designed to deliver the drug at the site of inflammation the synovium thereby maximizing its therapeutic effect and avoiding unwanted systemic adverse effects.1 This targeted drug delivery approach also has the potential to minimize the amount of drug required to control joint inflammation3 and increase local bioavailability by protecting it from degradation in the circulation.1

In essence, nanotechnology enables the redesign of alreadyeffective rheumatologic medications into nanoformulations that may confer greaterspecificity, longer therapeutic effect, and more amenable safety profile.4Nanoencapsulated nonsteroidal anti-inflammatory drugs (NSAIDs),5 liposomaland polymeric preparations of glucocorticoids,6 and nanosystems thatdirectly inhibit angiogenesis are just several examples of nanotherapies that havebeen tested in experimental models of inflammatory arthritis.7

Despite the promising findings observed in studies to date, further development and subsequent integration of nanotherapies in the management of RA remains hampered by the lack of efficacy and toxicity studies in humans. In an interview with Rheumatology Advisor, Christine Pham, MD, chief of the Division of Rheumatology at the Washington University School of Medicine in St Louis, discussed the advantages and challenges of applying nanotherapies in RA.

RheumatologyAdvisor: How can nanotechnology be applied in the treatment of RA?

ChristinePham, MD: Nanotechnology is a multidisciplinary approach aimed at the deliveryof therapeutic agents using submicron nanocarriers. In RA, the vessels at the siteof inflammation are leaky, allowing passage of these nanocarriers from the circulationto specific target sites in the joint environment.

RheumatologyAdvisor: Which RA drugs are suitable forthis approach?

DrPham: Many conventionalantirheumatic drugs such as methotrexate, glucocorticoids, and NSAIDs have beensuccessfully delivered by nanocarriers to mitigate inflammatory arthritis in experimentalmodels.

RheumatologyAdvisor: Whatare the main advantages of using nanotherapy/nanocarriers, as opposed to systemictherapy, in the treatment of RA?

DrPham: The mainadvantages are selective drug delivery to desired sites of action through passiveor active targeting, which can lead to increased local bioavailability and potentiallycan reduce unwanted off-target side effects. In addition, nanocarriers may increasethe solubility of certain drugs and protect therapeutics against degradation inthe circulation.

RheumatologyAdvisor: Howfar has the medical community gotten in developing (and testing) nanotherapies forRA? Which nanotherapies have shown the most promise?

DrPham: A numberof nanotherapeutics have been developed and tested in animal models of RA. Mosthave shown disease mitigation, however, none has so far made it to the clinic.

RheumatologyAdvisor: Whatneeds to happen before nanotherapies can get fully integrated into clinical practiceand treatment of patients with RA?

DrPham: Insufficientdata regarding long-term toxicity and optimal therapeutic efficacy have hamperedtheir integration into clinical practice. Anticytokine biologics have been verysuccessful, so nanotherapeutics need to show clearly that they have higher efficacyand lower toxicity for pharmaceutical companies to invest in their development forthe clinic.

Rheumatology Advisor: Are any other promising treatment strategies for RA currently under investigation?

DrPham: RNA interference(RNAi) has recently emerged as a specific way to silence gene expression. The invivo delivery of small interfering RNA (siRNA), however, remains a significant hurdle,given the short half-life of the molecule in the circulation. We have used a self-assemblingpeptide-based nanosystem that protects the siRNA from degradation when injectedintravenously and which has shown to mitigate experimental RA.8,9 siRNAworks by knocking down NFkappaB p65, asubunit of NF-kappa-B transcription complex which plays acentral role in inflammation in general and in RA in particular. This platform promisesto have real translational potential.

References

1. Pham CTN. Nanotherapeutic approaches for the treatment of rheumatoid arthritis. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2011;3(6):607-619.

2. Dolati S, Sadreddini S, Rostamzadek D, Ahmadi M, Jadidi-Niaragh F, Yousefi M. Utilization of nanoparticle technology in rheumatoid arthritis treatment. Biomed Pharmacother. 2016;80:30-41.

3. Rubinstein I, Weinberg GL. Nanomedicine for chronic non-infectious arthritis: the clinicians perspective. Nanomedicine. 2012;8(Suppl 1):S77-S82.

4. Henderson CS, Madison AC, Shah A. Size matters nanotechnology and therapeutics in rheumatology and immunology. Curr Rheumatol Rev. 2014;10(1):11-21.

5. Srinath P, Chary MG, Vyas SP, Diwan PV. Long-circulating liposomes of indomethacin in arthritic ratsa biodisposition study. Pharm Acta Helv. 2000;74:399-404.

6. Metselaar JM, Wauben MH, Wagenaar-Hilbers JP, Boerman OC, Storm G. Complete remission of experimental arthritis by joint targeting of glucocorticoids with long-circulating liposomes. Arthritis Rheum. 2003;48:2059-2066.

7. Koo OM, Rubinstein I, nyuksel H. Actively targeted low-dose camptothecin as a safe, long-acting, disease-modifying nanomedicine for rheumatoid arthritis. Pharm Res. 2011;28:776-787.

8. Zhou H-F, Yan H, Pan H, et al. Peptide-siRNA nanocomplexes targeting the NF-kB subunit p65 suppress nascent experimental arthritis. J Clin Invest. 2014;124:4363-4374.

9. Rai MF, Pan H, Yan H, Sandell L, Pham C, Wickline SA. Applications of RNA interference in the treatment of arthritis. Transl Res. 2019;214:1-16.

Link:
Nanotherapies for Rheumatoid Arthritis: Advantages, Challenges, and Future Direction - Rheumatology Advisor

Osteoarthritis is a degenerative joint disease that is the most common type of arthritis. Usually, it occurs among people of advanced age. But it can begin in middle age or even sooner, especially if theres been an injury to the joint.

While there are treatments available exercise, braces or canes, loss of excess weight, various pain relievers and anti-inflammatory medicines these are no cures, and none of the treatments are predictably effective. In fact, often they dont work at all, or help only a little. Injected steroids or synthetic lubricants can be tried as well. When all else fails, joint replacement surgery can be highly effective. In fact, about a million joint replacements (mostly knees and hips) are performed each year in the US.

So, its no surprise that people with osteoarthritis will try just about anything that seems reasonably safe if it might provide relief. My patients often ask about diet, including anti-inflammatory foods, antioxidants, low-gluten diets, and many others. Theres little evidence that most of these dietary approaches work. When there is evidence, it usually demonstrates no consistent or clear benefit.

Thats why a new study is noteworthy: it suggests that curcumin, a naturally occurring substance found in a common spice, might work for osteoarthritis.

In the study, researchers enrolled 139 people with symptoms of knee osteoarthritis. Their symptoms were at least moderately severe and required treatment with a nonsteroidal anti-inflammatory drug (NSAID). For one month, they were given the NSAID diclofenac (50 mg, twice daily) or curcumin (500 mg, three times daily).

Why curcumin? Its a naturally occurring substance, found in the spice turmeric, that has anti-inflammatory effects. Its use has been advocated for cardiovascular health, arthritis, and a host of other conditions. However, well-designed studies of its health benefits are limited.

Heres what this study found:

Not so fast. Its rare that a single study can change practice overnight, and this one is no exception. A number of factors give me pause:

Studies of this sort are vitally important in trying to understand whether dietary changes can be helpful for arthritis. While this new study provides support for curcumin as a treatment for osteoarthritis of the knee, Id like to see more and longer-term studies in osteoarthritis and other types of joint disease, as well as more extensive testing of its safety, before recommending it to my patients.

Read the rest here:
Curcumin for arthritis: Does it really work? - Harvard Health Blog - Harvard Health

Psoriasis in ankylosing spondylitis (AS) is not related to axial psoriatic arthritis (PsA), a type of psoriasis that causes lower back inflammation and pain similar to AS, according to a study published in Rheumatology.

The study included approximately 1303 patients with PsA and 766 patients with AS from 2 Canadian clinics. Of the patients with PsA, 477 had axial PsA and 826 had peripheral PsA. In the AS group, 91 participants had psoriasis and 675 did not.

Patients at both clinics were followed and assessed using a variety of diagnostic tools, with visits every 6 to 12 months for an average of 12.6 years for patients with axial PsA and 6.7 years for the patients with peripheral PsA. The average follow-up for AS with psoriasis was 5.4 years and 3.5 years for those without psoriasis.

The analysis showed that overall, patients with AS were younger at diagnosis, with an average age of 21.3 years in patients with psoriasis and 22.9 years in those without psoriasis compared with axial patients with PsA who had an average age at diagnosis of 34.4 years. There were also more males in both AS groups compared with the axial PsA group.

Spondyloarthritis is a family of inflammatory diseases causing arthritis and involves areas where ligaments and tendons attach to bones. AS is the most common form of spondyloarthritis and mainly affects the joints at the base of the spine where it meets the pelvis.

More patients in both AS groups tested positive for HLA-B27, a genetic marker for inflammatory arthritis of the spine and joints. Of the AS patients with psoriasis, 82% tested positive, while 75% of those without psoriasis tested positive. In the axial PsA group, only 19% tested positive.

Approximately 90% of patients with AS with psoriasis and 92% without psoriasis reported back pain compared with only 21% of patients with axial PsA. Furthermore, compared with patients with axial PsA, patients with AS and with and without psoriasis had a higher grade of sacroiliitis, or inflammation of the joints connecting the lower spine to the pelvis.

When the data were analyzed over time, there was also an increase in joint swelling in both patients with axial PsA and patients with peripheral PsA, whereas patients with AS with or without psoriasis were more likely to have back pain and a higher BASMI, or Bath Ankylosing Spondylitis Metrology Index, a measure of AS disease severity.

The study reveals that axial PsA and AS with psoriasis are 2 different diseases with different genetics, demographics, and disease expression, according to the study authors.

Reference

Excerpt from:
Ankylosing Spondylitis Not Linked to Axial Psoriatic Arthritis - Pharmacy Times

In rheumatoid arthritis patients in sustained remission on conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs), continued csDMARD therapy with stable doses led to fewer disease activity flares and less frequent radiographic joint damage progression than tapered csDMARD treatment, according to a study presented at annual meeting of the American College of Rheumatology in Atlanta on November 12.

More patients with rheumatoid arthritis reach and maintain sustained remission on csDMARDs after the implementation of treat-to-target strategies. However, the knowledge about whether csDMARDs can be tapered in rheumatoid arthritis remission is limited.

The primary objective of the ARCTIC REWIND trial was to assess the effect of tapering of csDMARDs on the risk of flares in rheumatoid arthritis patients in sustained clinical remission.

In the trial, 155 rheumatoid arthritis patients (mean age 55 years) in clinical remission, as measured by the Disease Activity Score (DAS) for 44 joint counts, for at least 12 months on stable csDMARD therapy were randomly assigned to continued stable csDMARD (n=78, 64 percent female, 78.2 percent methotrexate monotherapy users) or half dose csDMARD (n=77, 69 percent female, 84.4 percent methotrexate monotherapy users), with visits every four months. The primary endpoint was the proportion of patients with a disease flare during the 12-month study period (a combination of DAS > 1.6, a change in DAS > 0.6 and at least two swollen joints, or both the physician and patient agreed that a clinically significant flare had occurred). Radiographic joint damage at baseline and 12 months was scored by van der Heijde modified Sharp score (progression: 1 unit change/year).

In an interview with Rheumatology Network, Siri Lillegraven, M.D., M.P.H, Ph.D., of Diakonhjemmet Hospital in Oslo, Norway, said the study aimed to include patients in deep remission, who had been in remission for at least a year. The study was designed as a non-inferiority study, based on the hypothesis that csDMARDs could be tapered in such a patient cohort. We were thus somewhat surprised by the clear difference in flare rates and by the difference in radiographic progression that was observed.

In the primary analysis, 6.4 percent of patients in the stable csDMARD group experienced a flare during the 12 months, compared to 24.7 percent in the half-dose csDMARD group, giving a risk difference (95% confidence interval [CI]) of 18.3 percent (7.2 percent to 29.3 percent). Non-inferiority, with a margin of 20 percent, could not be claimed.

In the stable group, 40 percent adjusted DMARD medication following the flares, compared to 94.7 percent in the half-dose group. No progression of radiographic joint damage was observed in 79.5 percent of patients on stable DMARDs and 62.7 percent in the half-dose group, difference (95% CI) -17.7 percent (-33 percent, -2.3 percent). At 12 months, 91.8 percent of patients in the stable arm and 85.1 percent of patients in the half-dose arm were in DAS remission, with similar results for other remission definitions.

A total of 75 and 53 adverse events occurred in the stable and tapered groups, respectively, with serious adverse events in 2.6 percent of patients in the stable group and in 5.1 percent, including two serious infections, of patients in the tapered group.

The results support that if a patient reaches sustained remission in RA on csDMARDs, flares are very rare if stable DMARD dose is continued, and that stable csDMARD therapy should be the preferred choice for these patients.

We find it interesting that very few disease activity flares occurred if patients in sustained remission received stable treatment, illustrating that the RA disease course can have a favorable outcome, even with the cheapest and globally most available DMARDs, Dr. Lillegraven said.

REFERENCE

LO8 - Tapering of Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis Patients in Sustained Remission: Results from a Randomized Controlled Trial. Siri Lillegraven, M.D., M.P.H, Ph.D., 9 a.m., Tuesday, Nov. 12. 2019 ACR/ARP Annual Meeting, Atlanta

More:
Conventional Therapy Bests Tapered Therapy in Rheumatoid Arthritis - Rheumatology Network

Racers of all ages will soon be gearing up in their favorite holiday costumes, along with lacing up their sneakers as they aim to cross the finish line during the Arthritis Foundations annual Jingle Bell Run on Saturday, December 7, at George M. Steinbrenner Field.

With this fundraising event, individuals can participate in the 5K untimed, 5K chip-timed, a Kids Run and a 1-Mile Fun Run or Walk. Besides the race, other festivities will also be available, such as entertainment, a kids zone, food and beverages and more.

Arthritis Foundation Development Director of Tampa Sherry Yagovane explained where 100 percent of these proceeds go to.

The funds raised will support our Live Yes! Network events, educational programs and send children to summer camp, Yagovane said. We also fund research for better treatments, cures and assist patients with access to treatments through advocacy on a state and federal level.

In 1948, the Arthritis Foundation became established. Arthritis, also known as joint disease or joint pain, can affect individuals of all ages. In fact, 300,000 children and more than 50 million Americans are diagnosed with it, according to the Arthritis Foundation. To add, arthritis is considered the leading cause of disability in America.

A couple of families shared how the Arthritis Foundation assisted them and their loved ones. For example, Tracey Corns two daughters suffer from rheumatoid arthritis. She also has volunteered with the Arthritis Foundation for more than 10 years.

This foundation means so much to our family as it provided educational resources and more, Corn said.

Carrie Shank also stated her appreciation for the foundation, as her daughter, Aubriana Gonzalez, has suffered from JIA (Juvenile Idiopathic Arthritis) since the age of 2. Gonzalez was selected to be this years Jingle Bell Run Youth Honoree.

I am passionate about this cause, and as a parent I do not feel alone on this journey with the foundation being such a great educational tool for myself, family and friends, Shank said.

To register for the walk, visit https://events.arthritis.org/index.cfm?fuseaction=donorDrive.event&eventID=930.

For more information, contact Yagovane at 467-7520.

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Upcoming Jingle Bell Run Benefits The Arthritis Foundation - Osprey Observer

Compared with seven other biologics and a phosphodiesterase-4 inhibitor, the anti-IL-12/23 biologic ustekinumab was associated with a generally lower risk of serious infection requiring hospitalization in patients with psoriasis or psoriatic arthritis, researchers reported on November 12 at the American College of Rheumatology annual meeting in Atlanta.

The study included 123,383 adults (mean age 48, 50% female) with psoriasis or psoriatic arthrits who started treatment with a biologic DMARD (ustekinumab, secukinumab, ixekizumab, or a TNFi (adalimumab, etanercept, infliximab, certolizumab, golimumab) or the oral phosphodiesterase inhibitorapremilast.

Of the patients included in the analysis, 61 percent had psoriasis, 22 percent had psoriatic arthritis and 17 percent had both."Of 123,383 PsO or PsA patients, ustekinumab initiators had a generally lower risk of hospitalized serious infection compared to TNFi, IL-17 therapy, and apremilast initiators," reported Seoyoung C. Kim, M.D., of Brigham and Womens Hospital, Boston. Hospitalized serious infections were highest in patients who were prescribed infliximab and lowest in those who received ixekizumab and ustekinumab.

Ultimately, ustekinumab had a lower risk of hospitalized serious infection compared to other bDMARDs or apremilast. However, how well ustekinumab performed as compared to certolizumab and golimumab could not be determined due to the small sample size.Overall, data was consistent across all eight agents, though statistically weaker for certolizumab and golimumab.

The primary outcome was a composite endpoint of hospitalized serious bacterial, viral, or opportunistic infection. Follow-up started the first day a drug was dispensed and ran until the outcome was met, the database ended, or a patient left the study, died, or discontinued or switched drugs.

Having rigorous real-world based safety data directly comparing several drugs with a similar clinical indication is important when discussing a treatment option with patients and making a better-informed medical decision, Dr. Kim reported.

REFERENCEL01 - Comparative Risk of Hospitalized Serious Infection in Patients with Psoriasis and Psoriatic Arthritis: A Population-Based Multi-Database Study, Seoyoung C. Kim, MD, ScD, MSCE, 9 a.m., Tuesday, Nov 12. American College of Rheumatology 2019 annual meeting, Atlanta.

Follow this link:
Ustekinumab Linked to Lower Serious Infection Rates in Psoriasis and Psoriatic Arthritis - Rheumatology Network

Women with rheumatoid arthritis (RA) and other rheumatic conditions who want to breastfeed their newborns are generally able to so. Thats the finding from research presented at the 2019 annual meetingof the American College of Rheumatology in Atlanta on November 11, 2019.

Related: Can a Woman Who Has Rheumatoid Arthritis Have Kids?

Still, not every woman living with rheumatic disease with this desire does follow through, in some cases because of unfounded concerns about the safety of medicines they may be taking, says study coauthor Megan Clowse, MD, director of the Duke Autoimmunity in Pregnancy Clinic and associate professor of medicine at Duke University in Durham, North Carolina.

The good news is we found quite high levels of women desiring to breastfeed, and high numbers of those successfully doing so, Dr. Clowse says.

The 265 women in the study were part of a pregnancy registry Clowse set up for her practice a decade ago. There are a lot of women with rheumatic diseases who want to breastfeed, but there was very little data about this. When I set up the registry, I made sure we asked about breastfeeding, she says.

Related: People Living With Rheumatoid Arthritis Develop Resilience by Dealing With Disease Challenges

Before they delivered, 79 percent of the pregnant women indicated their desire to nurse. By the time of their postpartum visit an average of 7.5 weeks after delivering, three-quarters of these women were in fact doing so.

This means 25 percent of the women who had hoped to breastfeed were not. Some had tried but stopped, in some cases because they couldnt develop a milk supply or because their baby had health issues.

Other women said they gave up breastfeeding because they worried that the medicines they were taking might possibly pass through to the baby.

This mindset echoes the results of a survey conducted among members of the arthritis community CreakyJoints, presented at the American College of Rheumatology meeting in September 2017.

In that survey, 86 percent of women said they had either avoided taking medicines while breastfeeding, or they stopped nursing prematurely in order to resume the drugs needed to avoid postpartum flares.

Related: Rheumatoid Arthritis: Anatomy of a Flare

But for almost all rheumatoid arthritismedication, this concern is unfounded, Clowse says. New mothers can safely nurse on nearly all RA drugs in use today, she says.

Thats because medicines like Enbrel (etanercept) and Remicade (infliximab) dont readily pass to a baby through mothers milk, and any that do get through, especially with full-term infants, are not well absorbed by their gut, according to Mother to Baby, a website created by experts on birth defect risks.

Related: Rheumatoid Arthritis Medication

Clowse even tells patients they can nurse while taking methotrexate, a medicine that women must avoid while pregnant. Breastfeeding is a different biology from pregnancy. There is very minimal transfer in breast milk, she says.

The one type of medicine Clowse does restrict from nursing mothers is small-molecule Janus kinase (JAK) inhibitors, such as Xeljanz (tofacitinib), primarily because they are so new that there is not enough data on its nursing safety.

Clowse admits that she is especially enthusiastic about allowing patients to breastfeed, because she knows first hand that it can be an important part of a mothers experience.

Plus, breast milk is so healthy. According to the American College of Obstetricians and Gynecologists (ACOG), breast milk contains antibodies that protect infants from ear infections, diarrhea, respiratory illnesses, and allergies. It also can make it easier for moms to lose pregnancy weight, and it may reduce her risks of breast cancer and ovarian cancer. This is why ACOG recommends exclusive breastfeeding for the first 6 months of life, or longer if it is mutually desired by the mother and baby.

Related: How to Find a Rheumatologist

Clowse knows that her encouragement is likely more pronounced than that of other rheumatologists, and likely explains the high numbers she found in her study, she says.

In this research, women who exclusively formula-fed babies were likely to be younger and have less education and lower incomes than nursing mothers. Although black women in her study were less likely to nurse than whites, Clowse says that was related more to the education levels of the women in her registry than their race.

If your doctor erroneously tells you that you cannot nurse on any of the medicines you are taking, you can show them the information from Mother to Baby. Theres actual data, so you dont have to base the decision on myth, Clowse says.

The reality is you can breastfeed on almost all RA medication. You dont have to pick between taking care of your disease and breastfeeding your baby, she asserts.

Aimee Matsumoto, a public relations professional in Pasadena, California,who blogs about her experience having RA, is a new mom who is determined to nurse her infant. Matsumoto is not on any medicines, having had bad reactions to those she has previously tried.

Related: Home Remedies and Alternative Therapies for Rheumatoid Arthritis

Matsumoto was fortunate to go into remission during her pregnancy, but since her baby was born 9 months ago, her pain has come back with a vengeance. When her joints flare, it can be hard to breastfeed because of the challenges of holding the baby in a nursing position, she says.

Matsumoto overcomes this by using a nursing pillow, such as My Brest Friend, to take the weight off her hands. Other time she feeds her baby while both are lying down.

Related: Rheumatoid Arthritis: 20 Home Upgrades for Under $20

A lactation consultant is the best person to help you figure out ways you can nurse that protect your joints.

You can find one near you on the website of the International Lactation Consultant Association.

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Rheumatoid Arthritis and Breastfeeding: What Women With RA Need to Know - Everyday Health

The company said its RA 360 solution will support employees to reduce or maintain their current level of drug use

eWellness Healthcare Corporation (), the pioneer in physical therapy telehealth treatments, announced Tuesday that it is developing a new rheumatoid arthritis treatment platform called RA360.

In a statement, the Culver City, California-based company, said the new platform is expected to be available in the first quarter of 2020.

Rheumatoid arthritis and related autoimmune disorders are the leading cause of illness and disability in the US.

In 2019, one in four Americans has arthritis, or one of its 100 related autoimmune disorders, according to the company.

Those with rheumatoid arthritis will need to go on disability or stop work entirely within 2 years of onset, the group added.

However, the company said that its innovative RA360 solution will support employees to reduce or maintain their current level of theraputic drug use.

The company notes that costs associated with arthritis hit $128 billion in 2005, while other studies put the cost closer to $353 billion when payouts, lost wages and other associated medical costs were stacked up.

According to eWellness Healthcare, a reduction in symptoms will alleviate stress on the health care system and the employer.

Arthritis isnt an individual problem, its everyones problem. The damage cannot be undone but can be managed, the company added, while making the case that its new rheumatoid arthritis treatment platform RA360 was part of the solution.

eWellness Healthcare is the first physical therapy telehealth company to offer real-time distance monitored assessments and treatments.

Contact Uttara Choudhury at[emailprotected]

Follow her onTwitter:@UttaraProactive

Continued here:
eWellness Healthcare developing new rheumatoid arthritis treatment platform RA360 - Proactive Investors USA & Canada

BACKGROUND:

Recent studies have demonstrated patients with rheumatoid arthritis (RA) have deranged coagulation parameters predisposing them to venous thromboembolisms (VTEs). Therefore, the purpose of this study was to investigate whether patients who have RA undergoing primary TKA have higher rates of (1) VTEs; (2) readmission rates; and (3) costs of care.

Patients who have RA undergoing primary TKA were identified and matched to controls in a 1:5 ratio by age, sex, and comorbidities. Exclusions included patients with a history of VTEs and hypercoagulable states. Primary outcomes analyzed included rates of 90-day VTEs, along with lower extremity deep vein thromboses and pulmonary embolisms, 90-day readmission rates, in addition to day of surgery, and 90-day costs of care. A P-value less than .05 was considered statistically significant.

Patients who have RA were found to have significantly higher incidence and odds (OR) of VTEs (1.9 vs 1.3%; OR: 1.51, P < .0001), deep vein thromboses (1.6 vs 1.1%; OR: 1.55, P < .0001), and pulmonary embolisms (0.4 vs 0.3%; OR: 1.26, P= .0001). Study group patients also had significantly higher incidence and odds of readmissions (21.6 vs 14.1%; OR: 1.67, P < .0001) compared to controls. In addition, RA patients incurred significantly higher day of surgery ($12,475.17 vs $11,428.96; P < .0001) and 90-day costs of care ($15,937.34 vs $13,678.85; P < .0001).

After adjusting for age, sex, and comorbidities, the study found patients who have RA undergoing primary TKA had significantly higher rates of VTEs, readmissions, and costs.

Read the original:
Rheumatoid Arthritis Increases Venous Thromboemboli, Readmissions, and Costs of Care After Primary Total Knee Arthroplasty: A Matched-Control Analysis...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that positive results from a Phase 3 investigational study of tofacitinib in children and adolescents aged two to less than 18 with juvenile idiopathic arthritis (JIA) will be presented for the first time during a late-breaking oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting (November 8-13, Atlanta, GA). The study of tofacitinib in JIA is investigative and JIA is not an FDA-approved indication for XELJANZ. Pfizer has plans to file for the indication in 2020.

The JIA study is a Phase 3, randomized, double-blind, placebo-controlled withdrawal study that included 225 patients with polyarticular course JIA (n=184), psoriatic arthritis (n=20) or enthesitis related arthritis (n=21). The study evaluated the efficacy and safety of tofacitinib taken as either a 5 mg tablet or as a 1 mg/mL oral solution twice daily based on the subjects body weight.

The trial met its primary endpoint showing that in patients with polyarticular JIA, the occurrence of disease flare in patients treated with tofacitinib was significantly lower than patients treated with placebo at week 44. In this study, disease flare was defined as a 30 percent or more worsening in at least three of the six variables of the JIA core set (outcome measures used in JIA clinical trials).

The most common adverse events in this study of any treatment group were upper respiratory tract infection, headache, nasopharyngitis, nausea, pyrexia, disease progression, vomiting and JIA. There were no cases of death, major adverse cardiovascular events (MACE), malignancies, thrombosis, opportunistic infection or tuberculosis. There were two patients with herpes zoster and four patients with serious infections in the tofacitinib treatment arm throughout the course of the study.

Pediatric patients living with juvenile idiopathic arthritis need additional options, including oral therapies, to treat this chronic inflammatory disease, said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. We are encouraged by the results from our pivotal Phase 3 investigational study of tofacitinib in patients with polyarticular juvenile idiopathic arthritis and look forward to filing for this indication with the FDA in 2020.

About the JIA Study

The A3921104 Phase 3 study had two phases. During the run-in phase, all subjects enrolled in the study received open-label tofacitinib for 18 weeks. At the end of the 18-week run in phase, only subjects who achieved at least a JIA ACR30 response were randomized into the 26-week, double-blind, placebo-controlled, withdrawal phase to receive either tofacitinib or placebo through the end of the study duration at week 44. For more information about study A3921104, please visit https://www.clinicaltrials.gov.

About XELJANZ (tofacitinib)

XELJANZ (tofacitinib) is approved in the U.S. for adult patients in three indications: moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, active psoriatic arthritis (PsA) after disease modifying antirheumatic drug (DMARD) failure and moderately to severely active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure. XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 208,000 adult patients (the majority of whom were RA patients) worldwide in the last seven years. 1,2,3

As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.

FDA APPROVED INDICATIONS

Rheumatoid Arthritis

Psoriatic Arthritis

It is important to note that a dosage of Xeljanz 10 mg twice daily is not recommended for the treatment of rheumatoid arthritis or psoriatic arthritis.

Ulcerative Colitis

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with XELJANZ/XELJANZ XR are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.

If a serious infection develops, interrupt XELJANZ/XELJANZ XR until the infection is controlled.

Reported infections include:

The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. Avoid use of XELJANZ/XELJANZ XR in patients with an active, serious infection, including localized infections, or with chronic or recurrent infection.

In the UC population, XELJANZ 10 mg twice daily was associated with greater risk of serious infections compared to 5 mg twice daily. Opportunistic herpes zoster infections (including meningoencephalitis, ophthalmologic, and disseminated cutaneous) were seen in patients who were treated with XELJANZ 10 mg twice daily.

The risks and benefits of treatment with XELJANZ/XELJANZ XR should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection, or those who have lived or traveled in areas of endemic TB or mycoses. Viral reactivation including herpes virus and Hepatitis B reactivation have been reported. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ/XELJANZ XR, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Caution is also recommended in patients with a history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infection.

MORTALITY

Rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with XELJANZ 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with XELJANZ 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study.

XELJANZ 10mg twice daily or XELJANZ XR 22mg once daily is not recommended for the treatment of RA or PsA. For UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications.

Consider the risks and benefits of XELJANZ/XELJANZ XR treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing XELJANZ/XELJANZ XR in patients who develop a malignancy.

Malignancies (including solid cancers and lymphomas) were observed more often in patients treated with XELJANZ 10 mg twice daily dosing in the UC long-term extension study.

Other malignancies were observed in clinical studies and the post-marketing setting including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer. NMSCs have been reported in patients treated with XELJANZ. In the UC population, treatment with XELJANZ 10 mg twice daily was associated with greater risk of NMSC. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS

Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, has been observed at an increased incidence in RA patients who were 50 years of age and older with at least one CV risk factor treated with XELJANZ 10 mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers in a large, ongoing postmarketing safety study. Many of these events were serious and some resulted in death. Avoid XELJANZ/XELJANZ XR in patients at risk. Discontinue XELJANZ/XELJANZ XR and promptly evaluate patients with symptoms of thrombosis. For patients with UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. In a long-term extension study in UC, four cases of pulmonary embolism were reported in patients taking XELJANZ 10 mg twice a day, including one death in a patient with advanced cancer.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in XELJANZ clinical trials, although the role of JAK inhibition is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). There was no discernable difference in frequency of gastrointestinal perforation between the placebo and the XELJANZ arms in clinical trials of patients with UC, and many of them were receiving background corticosteroids. XELJANZ/XELJANZ XR should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs).

HYPERSENSITIVITY

Angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving XELJANZ/XELJANZ XR some events were serious. If a serious hypersensitivity reaction occurs, promptly discontinue tofacitinib while evaluating the potential cause or causes of the reaction.

LABORATORY ABNORMALITIES

Lymphocyte Abnormalities: Treatment with XELJANZ was associated with initial lymphocytosis at one month of exposure followed by a gradual decrease in mean lymphocyte counts. Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with a count less than 500 cells/mm3. In patients who develop a confirmed absolute lymphocyte count less than 500 cells/mm3, treatment with XELJANZ/XELJANZ XR is not recommended. Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection. Monitor lymphocyte counts at baseline and every 3 months thereafter.

Neutropenia: Treatment with XELJANZ was associated with an increased incidence of neutropenia (less than 2000 cells/mm3) compared to placebo. Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with an ANC less than 1000 cells/mm3. For patients who develop a persistent ANC of 500-1000 cells/mm3, interrupt XELJANZ/XELJANZ XR dosing until ANC is greater than or equal to 1000 cells/mm3. In patients who develop an ANC less than 500 cells/mm3, treatment with XELJANZ/XELJANZ XR is not recommended. Monitor neutrophil counts at baseline and after 4-8 weeks of treatment and every 3 months thereafter.

Anemia: Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with a hemoglobin level less than 9 g/dL. Treatment with XELJANZ/XELJANZ XR should be interrupted in patients who develop hemoglobin levels less than 8 g/dL or whose hemoglobin level drops greater than 2 g/dL on treatment. Monitor hemoglobin at baseline and after 4-8 weeks of treatment and every 3 months thereafter.

Liver Enzyme Elevations: Treatment with XELJANZ was associated with an increased incidence of liver enzyme elevation compared to placebo. Most of these abnormalities occurred in studies with background DMARD (primarily methotrexate) therapy. If drug-induced liver injury is suspected, the administration of XELJANZ/XELJANZ XR should be interrupted until this diagnosis has been excluded. Routine monitoring of liver tests and prompt investigation of the causes of liver enzyme elevations is recommended to identify potential cases of drug-induced liver injury.

Lipid Elevations: Treatment with XELJANZ was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Maximum effects were generally observed within 6 weeks. There were no clinically relevant changes in LDL/HDL cholesterol ratios. Manage patients with hyperlipidemia according to clinical guidelines. Assessment of lipid parameters should be performed approximately 4-8 weeks following initiation of XELJANZ/XELJANZ XR therapy.

VACCINATIONS

Avoid use of live vaccines concurrently with XELJANZ/XELJANZ XR. The interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ/XELJANZ XR therapy.

PATIENTS WITH GASTROINTESTINAL NARROWING

Caution should be used when administering XELJANZ XR to patients with pre-existing severe gastrointestinal narrowing. There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs utilizing a non-deformable extended release formulation.

HEPATIC and RENAL IMPAIRMENT

Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended.

For patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 5 mg twice daily, reduce to XELJANZ 5 mg once daily.

For UC patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 10 mg twice daily, reduce to XELJANZ 5 mg twice daily.

ADVERSE REACTIONS

The most common serious adverse reactions were serious infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis (RA) with XELJANZ 5 mg twice daily and placebo, respectively, (occurring in greater than or equal to 2% of patients treated with XELJANZ with or without DMARDs) were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension. The safety profile observed in patients with active psoriatic arthritis treated with XELJANZ was consistent with the safety profile observed in RA patients.

Adverse reactions reported in 5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and 1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials for UC were: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.

USE IN PREGNANCY

Available data with XELJANZ/XELJANZ XR use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal studies, tofacitinib at 6.3 times the maximum recommended dose of 10 mg twice daily demonstrated adverse embryo-fetal findings. The relevance of these findings to women of childbearing potential is uncertain. Consider pregnancy planning and prevention for females of reproductive potential.

Please see full Prescribing Information, including BOXED WARNING for XELJANZ/XELJANZ XR available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.

Pfizer Inc.: Breakthroughs that change patients lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com. In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of November 12, 2019. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about XELJANZ (tofacitinib) and a potential new indication for the treatment of juvenile idiopathic arthritis, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; uncertainties regarding the commercial success of XELJANZ and XELJANZ XR; uncertainties regarding the commercial impact of the update to the U.S. prescribing information for XELJANZ and XELJANZ XR; uncertainties regarding the commercial impact of any potential actions by other regulatory authorities, including as a result of the ongoing review by the European Medicines Agencys scientific committee, based on analysis of clinical trial A3921133 or other data, which will depend, in part, on labeling determinations; whether and when any applications for the potential new indication for XELJANZ may be filed in any jurisdictions; whether and when any applications that may be filed for the potential new indication or that may be pending or filed for any other potential indications for XELJANZ or XELJANZ XR in any jurisdictions may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the products benefits outweigh its known risks and determination of the products efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, safety, manufacturing processes and/or other matters that could affect the availability or commercial potential of XELJANZ and XELJANZ XR; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

_______________________1 Pfizer Data on File. XELJANZ Worldwide Registration Status.2 ClinicalTrials.gov. Tofacitinib RA Studies. https://clinicaltrials.gov/ct2/results?term=tofacitinib%2C+rheumatoid+arthritis%2C+ORAL&type=&rslt=&recr=&age_v=&gndr=&cond=Rheumatoid+Arthritis&intr=&titles=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&rcv_s=&rcv_e=&lup_s=&lup_e=. Accessed August 1, 2019.3 Pfizer. Data on File. Tofa Counts. April 2019

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Pfizer Announces Results of Phase 3 Study for XELJANZ (tofacitinib) in Juvenile Idiopathic Arthritis Ahead of Presentation at 2019 American College of...

The late Gary Middleton, founder of Little Rock design, marketing and print-solutions company Magna IV, was one of the first chairmen for the Arkansas Arthritis Foundation's Jingle Bell Run/Walk for Arthritis.

As a result, Magna IV has remained a strong supporter of the annual fundraiser, and so has Steven Schilling, the company's director of sales.

Schilling, a longtime Arthritis Foundation board member, has taken over as the Jingle Bell Run chairman for the fourth year in a row. That follows four years as the event's volunteer coordinator.

As chairman, his job, besides the actual raising of the money, is to find sponsors, vendors and volunteers and watch over the logistics, which, considering the scope of the event, can be formidable. It incorporates 10K and 5K runs, a one-mile walk and an Elf Run for kids.

"I've been with Magna IV for 26 years," Schilling says. "The owner was involved, so that's how I got involved."

This year's run is on Dec. 7, starting and ending at the Clinton Presidential Center, 1200 President Clinton Ave., Little Rock. The course takes runners and walkers to the Broadway Bridge, which they traverse into North Little Rock, returning south of the river over the Junction Bridge.

Arthritis Foundation chapters stage an annual Jingle Bell Run in more than 100 cities nationwide. The foundation bills it as the longest-running, holiday-theme 5K race in the United States and "the original festive race for charity, bringing people from all walks of life together to champion arthritis research and resources."

Register at jbr.org/LittleRock. Participants are encouraged to wear a seasonal costume and tie jingle bells to their shoelaces. "Every runner gets jingle bells, so as the race progresses, there's a lot of jingling going on," Schilling says.

They're also encouraged to sign up in teams, although individual runners and walkers are welcome. Last year's event drew 800, most of them forming about 50 teams, Schilling says. He's hoping to have at least that many taking part this year, and to raise as much or more than last year's $75,000 take.

The money comes from sponsorships and registration fees, which range from $40 in advance, $45 day of race, for the timed 10K (which includes T-shirt, timing chip, gear check and bells) to $30 for what the foundation calls "Jingle in Your Jammies" ("Can't attend the event, but still want to be part of the fun? Choose this option to receive a shirt and [raise funds] for a cure!") -- and, Schilling adds "You get to stay in bed."

In addition to T-shirts, participants get goody bags (L'Oreal is a national sponsor, so they usually include makeup and lipsticks) and a small amount of free food, primarily, at least in years past, sliced fruit. Ben E. Keith is supplying water.

The event requires 30-40 volunteers for setup, post-race tear-down and keeping things running in between. Schilling says about two-thirds of those come each year from the Central High ROTC.

"They're required to have community service hours," he explains, and because their mission is military, "they're on time and eager to work." During the race they're out on the course, operating water stations and "making sure runners are where they're supposed to be."

Things kick off around 9:15 a.m., as participants register and pick up packets and timing chips, the Elf Village (kids zone) and vendor booths open, choral groups sing Christmas carols and attendees can take pictures with Santa. The Kids Run begins at 10:15, followed by the 10K at 10:30, the 5K at 11 and the Joe Cook 1 Mile Memorial Walk, named for the chairman who was Schilling's predecessor, at 11:10. An awards ceremony is slated for 11:40.

There are also costume contests for humans -- and pets.

"Some people show up that have nothing to do with the run," Schilling says. "They just want to enter their pet in the contest." It doesn't draw too many unusual pets -- mostly dogs and cats, although Schilling says if you have, say, a monitor lizard, it's welcome. "But you get some crazy costumes," he says. For example: "We've had some very small dogs dressed as very big reindeer."

Humans often show up in very ugly Christmas sweaters. "I've seen some pretty horrendous sweaters," he adds.

It's all part of what he describes as the event's family-friendly, laid-back approach and fun vibe.

More than 54 million Americans live with arthritis, including 673,000 in Arkansas, according to foundation statistics. Schilling says he's one of those.

"The Jingle Bell Run is a 28-year tradition in Little Rock and known nationally as the original festive race for charity," says Angela Harris, the state chapter's executive director.

"Our honorees and volunteers are what make this event successful and memorable every year, and this year we're humbled to honor Sherry Little, who is a true Arthritis Warrior and continually commits her time to raising awareness and funds for our cause year after year." Little has walked more than 15 years in honor of her daughter, Michelle, and to "spread awareness [that] arthritis can strike at any age."

Lindee and Lola Throckmorton are this year's young honorees; other laureates include Brian Barnett of the University of Arkansas for Medical Sciences Spine Institute, corporate chair; Dr. Joel Smith, medical honoree; Martin Orthopedics; and presenting sponsor BKD.

Schilling's volunteer credentials include four years as a coach for Resurrecting Baseball in the Inner City, based at Little Rock's Lamar Porter Field, aimed at giving at-risk teens something to do in the summers. He also volunteered for more than 20 years as a coach for his three kids' youth soccer, baseball, basketball and football teams, but that's over -- his youngest is turning 21.

He stepped away from the foundation for a while but returned to the board eight years ago.

"The race was so important to Mr. Middleton, and out of my relationship to and respect for him, it became important to me. And my employer, Magna IV, has been very supportive of my involvement."

Photo by Eric E. HarrisonSteven Schilling credits his relationship with and respect for Gary Middleton, founder of Magna IV and a strong supporter of the Arkansas Arthritis Foundation and its Jingle Bell Run, for his involvement with the foundation.

High Profile on 11/10/2019

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Magna IV true to tradition in jingling run for arthritis - Arkansas Online

Graph 1

Vectra Predicts Risk of Radiographic Progression in 1 Year

Myriad Genetics, Inc.

Graph 2

Vectra Predicts Risk of Cardiovascular Events in Patients with RA

Myriad Genetics, Inc.

SALT LAKE CITY, Nov. 09, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in precision medicine, announced that its Myriad Autoimmune business unit will present new data on the Vectra test at the 2019 ACR/ARP Annual Meeting being held Nov. 8-13, 2019 in Atlanta, GA. The key findings are that the Vectra test predicts the risk of radiographic progression (RP) within one year, and the Vectra score, in combination with other clinical measures, predicts the risk of a cardiovascular (CV) event in people with rheumatoid arthritis (RA).

A hallmark feature ofrheumatoid arthritisisinflammation, which increases the risk of joint damage, cardiovascular disease and other comorbidities, said Elena Hitraya, M.D., Ph.D., rheumatologist and chief medical officer at Myriad Autoimmune. The data being presented by our academic collaborators at ACR show that the Vectra test accurately measures inflammation and can help predict patients risk of adverse health outcomes, enabling clinicians to tailor precision treatment plans to achieve better outcomes.

Vectra Posters

Title:Predicting Risk of Radiographic Progression for Patients with Rheumatoid Arthritis.Presenter:Jeff Curtis, M.D., M.S., MPH, University of Alabama at Birmingham.Date:Sunday, Nov. 10, 2019. 9:00-11:00 a.m.Location:Poster 466.

This study evaluated the ability of the Vectra test to predict patients individual percentage risk of RP within one year. The analysis included combined data from 973 patients in four cohorts. The results demonstrate that the adjusted Vectra score was a superior predictor of RP within one year compared to DAS28-CRP, CRP, CDAI and swollen joint count. Additionally, the risk of permanent joint damage increased continuously with the adjusted Vectra score, meaning patients with a low adjusted Vectra score had a one to three percent risk of RP in one year, while patients with a moderate-to-high score had between seven and 47 percent risk (Graph 1). Based on these new data, the company is working to enhance the Vectra test report to provide patients with their individual risk of radiographic progression in one year.

To view Graph 1: Vectra Predicts Risk of Radiographic Progression in 1 Year,please visit the following link:https://www.globenewswire.com/NewsRoom/AttachmentNg/514919cd-81ca-4084-81df-682fedc1784b

Too often people with RA are over- or under-treated because it is difficult for clinicians to accurately measure inflammation and determine the long-term prognosis of RA patients. As a result, some people are at increased risk of rapid radiographic progression, said Jeff Curtis, M.D., M.S., MPH, lead investigator, rheumatologist and Professor of medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham. It is critical that clinicians have reliable information when making treatment decisions. Our study demonstrated that the Vectra score was the strongest predictor of radiographic progression, which may help inform treatment plans and prevent future joint damage.

Title:Derivation and Validation of a Biomarker-Based Cardiovascular Risk Prediction Score in Rheumatoid Arthritis.Presenter:Jeff Curtis, M.D., M.S., MPH; University of Alabama at Birmingham.Date:Tuesday, Nov. 12, 2019. 9:00-11:00 a.m.Location:Poster 2350.

This study evaluated 30,751 Medicare patients with RA to develop and validate the Vectra CVD score, which predicts risk for a first cardiovascular (CV) event by combining data from Vectra and clinical measures. The primary CV outcome was a composite of three types of CV events heart attack, stroke, and CV death occurring within 3 years from testing. When the performance of the Vectra CVD score was compared to four other CV prediction models, the Vectra CVD score was a significant predictor of CV risk and was superior to all four other models. Importantly, when risk scores were converted to 3-year percentage risk for having a CV event, approximately 80 percent of patients were found to have a moderate or high risk of a CV event over 3 years, based on risk categories analogous to those of the American College of Cardiology/American Heart Association 2018 guidelines (Graph 2).

To view Graph 2: Vectra Predicts Risk of Cardiovascular Events in Patients with RA, please visit the following link:https://www.globenewswire.com/NewsRoom/AttachmentNg/c902b4ec-a3c8-439f-9557-0a9b05631a1f

People with rheumatoid arthritis have almost double the risk of heart attack, stroke and atherosclerosis. Traditional CV risk factors alone do not fully explain the increased rates of CV events in RA, and inflammation is a missing component that is measured by the Vectra test, said Dr. Curtis. In this study, the Vectra CVD score effectively predicted CV risk in people with RA. We believe the Vectra CVD score may assist clinicians to more quickly identify patients at high risk for CV events and target interventions that can be potentially life-saving.

The company plans to publish these new data in peer reviewed medical journal and make the Vectra CVD score available to clinicians in fiscal year 2020. Please visit Myriad Autoimmune at booth #1419 to learn more about Vectra. Follow Myriad on Twitter via @myriadgenetics and follow meeting news by using the hashtag #ACR19.

About VectraVectra is a multi-biomarker molecular blood test that provides an objective and personalized measure of inflammatory disease activity in patients with rheumatoid arthritis. Vectra provides unsurpassed ability to predict radiographic progression and can help guide medical management decisions with the goal of improving patient outcomes. Vectra testing is performed at a state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician five to seven days from shipping of the specimen. Physicians can receive test results by fax or the private web portal, VectraView. For more information on Vectra, please visit: http://www.vectrascore.com.

About Myriad GeneticsMyriad Genetics Inc. is a leading precision medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on five critical success factors: building upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore, Prolaris, Foresight and Prequel are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company presenting new data on the Vectra test at the 2019 ACR Annual Meeting; the Vectra test enabling clinicians to tailor precision treatment plans to achieve better outcomes; the Vectra score helping inform treatment plans and prevent future joint damage; the Vectra CVD score assisting clinicians to more quickly identify patients at high risk for CV events and target interventions that can be potentially life-saving; publishing these new data in peer reviewed medical journal; making the Vectra CVD score available to clinicians in fiscal year 2020; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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New Studies Demonstrate the Predictive Value of the Vectra Test in People Diagnosed with Rheumatoid Arthritis - GlobeNewswire

Video telemedicine may be anoption for care inrheumatoid arthritis (RA) for patients who have high disease activity andpositive perceptions of telemedicine, and for physicians who frequently utilizetelemedicine technologies, according to research published inArthritis Care and Research.

Using data from patients within the Alaska Tribal Health System, researchers sought to determine the baseline factors associated with the use of telemedicine for RA. Adults 18 and older with an RA diagnosis who were seen at the Alaska Native Medical Center between August 2016 and March 2018 were invited to participate in the study.

Throughout the baseline enrollment period,rheumatology-specific telemedicine was available in the form of synchronousvideo teleconference. Physicians were briefly and generally trained on the useof the telemedicine equipment. Telemedicine was made available to patients in 2different scenarios: Those residing in rural areas could use the videoteleconference to reduce travel burden, or care was provided at the AlaskaNative Medical Center in Anchorage from a rheumatologist who wasvideo-conferenced in from out of state.

In total, 122 patients participated in the study. In boththe telemedicine and in-person groups, patient demographics were similar withrespect to age, sex, and disease duration (mean 10 years). A majority ofparticipants across both groups had positive autoantibodies (>85% positivefor rheumatoid factor and anticyclic citrullinated peptide), and almost allpatients had been prescribed disease-modifying antirheumatic drugs within thelast year.

Both groups had a mean number of rheumatology visits withinthe past year higher than 2; however, the telemedicine group had more visitsoverall (mean 2.95 vs 2.39;P=.011).The telemedicine group also had higher survey scores, which indicated morepositive perceptions of telemedicine and a higher mean rheumatologisttelemedicine rate, indicating that they were seeing a rheumatologist whoperformed telemedicine visits more frequently.

Investigators conducted a multivariate analysis for age,sex, number of rheumatologist visits in the past year, Routine Assessment ofPatient Index Data 3score, telemedicine survey score, ever seen bytelemedicine by any provider, and mean rheumatologist telemedicine rate. Thestrongest association with patient use of telemedicine was the meanrheumatologist telemedicine rate (odds ratio [OR] 4.14; 95% CI, 2.35-8.00).Additional strong associations were observed between the telemedicineperception survey score and use of telemedicine (OR 2.76; 95% CI, 1.32-6.18),the number of rheumatologist visits in the past year, and Routine Assessment ofPatient Index Data 3 score.

In addition, patient perceptions of telemedicine were an important factor associated with the choice to use telemedicine for RA follow up vs in-person care only. Survey results indicated that patients who had ever been seen by telemedicine responded more favorably than those who had not. Overall, patients still preferred to be seen by a specialist in person, regardless of group (61% of the telemedicine group and 74% of the in-person-only group), but those in the telemedicine group were more likely to feel that care provided via video was as good as care provided in person.

Limitations to the study included the observational natureof the research, possible unmeasured staff or provider biases that contributedto patient choice, and the unique setting that may prevent a generalization ofresults to other populations.

Future studies will investigate disease activity over time and quality of care for RA in the setting of telemedicine compared [with] usual care and will help inform practice further, the researchers concluded.

Reference

Ferruci ED, Holck P, Day GM, Choromanski TL, Freeman SL.Factors associated with use of telemedicine for follow-up of rheumatoid arthritis[published online August 17, 2019].Arthritis Care Res.doi: 10.1002/acr.24049

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Rheumatoid Arthritis Care and the Option of Telemedicine - Rheumatology Advisor