StemCell Therapy

For the first time, nationally endorsed performance measures in British Columbia, Canada, were operationalized using administrative data, allowing for population-level quality of care reports on patients with rheumatoid arthritis (RA). The reports showed improvements in access to rheumatologist care and early treatment over time, although suboptimal rates of specialist follow-up and accompanying low levels of disease modifying antirheumatic drug (DMARD) use persisted, according to study findings published in Arthritis Care & Research.

This longitudinal population-based RA cohort study used administrative health data to operationalize and report on 4 of 6 nationally endorsed RA performance measures developed by the Arthritis Alliance of Canada. The 4 tested performance measures were: percentage of incident patients with 1 rheumatologist visits within 365 days of diagnosis; proportion of prevalent RA patients with 1 rheumatologist visits per year; percentage of prevalent RA patients who received DMARD therapy; and time from RA diagnosis to DMARD prescription. All adult patients who received care for RA in British Columbia from January 1, 1997, to December 31, 2009, were identified and followed until December 2014.

A total of 38,673 incident cases and 57,922 prevalent cases of RA were included in the cohort. Although the percentage of patients seeing a rheumatologist in the first year of diagnosis was suboptimal, rates improved from 35% in 2000 to 65% in 2009. Improved performance was noticed in patients who ever saw a rheumatologist in follow-up, which increased from 74% in 2000 to 96% in 2009; however, the lower performance in earlier years could have been due to longer follow-up times. When the measure was reported as patients seeing a rheumatologist within the first 5 years, the performance became 88% in 2000 and 97% in 2009.

The percentage of patients with RA under the care of a rheumatologist declined from 79% in 2001 to 39% in 2014 using the fixed interval method, or from 82% in 2001 to 42% in 2014 using the gaps method. Among patients not under the care of a rheumatologist, DMARD use was suboptimal, with little improvement over time. Overall, regardless of physician type, only 37% of patents were prescribed a DMARD in 2014, with the highest rates of DMARD use (87% in 2014) seen among patients under active rheumatology care. The median time from RA diagnosis to DMARD therapy initiation in patients seen by a rheumatologist improved from 49 days in 2000 to 23 days in 2009, with 21% and 34% receiving DMARD treatment within the 14-day benchmark in 2000 and 2009, respectively.

The investigators concluded that the results of this study will inform further reporting on the measures nationally and help serve in benchmarking when planning quality improvement and advocacy work.

Timely communication of performance at the practice level could be used to influence clinical care, they added.

Reference

Barber CEH, Marshall DA, Szefer E, et al. A population-based approach to reporting system-level performance measures for rheumatoid arthritis care [published online March 7, 2020]. Arthritis Care Res (Hoboken). doi:10.1002/acr.24178

The rest is here:
PopulationBased Reports of National Rheumatoid Arthritis Care Performance Measures - Rheumatology Advisor

Rheumatoid arthritis is an autoimmune condition, which means it's caused by the immune system attacking healthy body tissue.

Osteoarthritis, on the other hand, is attributed to lifestyle factors such as injury and obesity, and genetic factors such as family history.

Both are also united in their lack of cure but there are a number of treatments to help relieve the symptoms.

Several research studies suggest the anti-inflammatory properties found in ginger can have an alleviating effect, for example.

READ MORE:Arthritis symptoms: The tell-tale signs you could have the condition in your knees

Taking ginger extract helped to reduce knee pain upon standing and after walking.

What's more, researchers in study published in The Journal of Pain found that ginger was an effective pain reliever for human muscle pain resulting from an exercise-induced injury.

Participants who ingested two grams of either raw ginger or heated ginger experienced reduced pain and inflammation.

Heat-treated ginger was thought to have a stronger effect, but both types of ginger were found to be equally helpful.

Too much weight places excess pressure on the joints in your hips, knees, ankles and feet, leading to increased pain and mobility problems, says the NHS.

In fact, exercise can bring both direct and indirect benefits for managing arthritis, notes the health body.

In addition to aiding weight loss, exercise can:

"Your GP can recommend the type and level of exercise that's right for you," adds the NHS.

Original post:
Arthritis treatment: The natural extract shown to be as effective as a pain relief drug - Express

If you or someone you love has rheumatoid arthritis, youve probably thought about remission from rheumatoid arthritis more than once. As you likely know, rheumatoid arthritis is a very serious illness, and it can often be debilitating. So the concept of achieving remission can feel like a beacon of hope.

Today more than 1.3 million Americans are living with rheumatoid arthritis, and about 75 percent of them are women, according to the American College of Rheumatology. Rheumatoid arthritis is the most common form of autoimmune arthritis and causes pain, stiffness, and swelling in the joints of the hands, feet, and wrists.

As a quick refresher: Autoimmune diseases like rheumatoid arthritis arise when the bodys immune systemwhich typically keeps you healthy and defends against diseasestops working properly and mistakenly attacks healthy cells in your body, according to the U.S. National Library of Medicine. But with new advances in treatment options, it is possible to stop or slow the progression of rheumatoid arthritis with the right treatment. In some cases, people are even able to achieve a state of remission where the joints arent seeing further damage and the disease doesnt interfere with day-to-day living. Heres what you need to know about achieving rheumatoid arthritis remission.

Rheumatoid arthritis remission is defined as very, very low disease activity, or no disease activity for a particular individual, Dana DiRenzo, M.D., rheumatologist and instructor of medicine at Johns Hopkins Medicine, tells SELF.

You dont need to be completely free of symptoms to be in a state of remission, Dr. DiRenzo explains, but you would rate how your joints are feeling somewhere around a 0 or 1 out of 10, where 10 indicates the most pain or discomfort and 0 is the least.

There is no definitive answer to how many people achieve remission from rheumatoid arthritis, but it may fall somewhere between 5% and 45%, according to a 2017 analysis of studies. Diagnosis and aggressive treatment early on in the course of the illness seems to be an important factor in achieving remission, according to the Arthritis Foundation.

Remission can be achieved at any point, Dr. DiRenzo says, but its more likely with earlier treatment, especially within the first six to 12 months or so after diagnosis.

While there isnt one specific test that can show when someone is in remission, a rheumatologist can determine if youre in remission by evaluating your reported symptoms along with a number of clinical signs and symptoms. In the process, theyll often use a scoring guide such as the Clinical Disease Activity Index (CDAI) or the Disease Activity Score (DAS / DAS28). These scoring guides bring together different criteria and test results to measure disease activity for each patient in order to indicate how active the disease is at a specific point in time.

So this way we have an idea of whos doing really well and whos having a lot of disease activity, Fotios Koumpouras, M.D., rheumatologist, assistant professor of medicine at Yale School of Medicine, and director of the Yale Lupus Program, tells SELF.

Being in remission doesnt look exactly the same for everyone, but if youre in remission youll experience very minimal joint symptoms or none at all, and your joint symptoms wont interfere with your day-to-day life in any way.

Typically, a combination of medication and lifestyle changes are needed in order to achieve remission, but the exact requirements for achieving remission wont be the same from person to person.

Read more:
What Does It Mean to Be in Remission from Rheumatoid Arthritis? - Self

Objective:To investigate the association between allergic rhinitis (AR) and the risk of rheumatoid arthritis (RA).

Methods:Potentially eligible studies were identified from MEDLINE and EMBASE databases from inception to November 2019. Eligible cohort study must report relative risk with 95% confidence intervals (95% CIs) of incident RA between AR patients and comparators. Eligible case-control studies must include cases with RA and controls without RA, and must explore their history of AR. Odds ratio with 95% CIs of the association between AR and RA must be reported. Point estimates with standard errors from each study were combined using the generic inverse variance method.

Results:A total of 21,824 articles were identified. After two rounds of the independent review by three investigators, two cohort studies and 10 case-control studies met the eligibility criteria. The pooled analysis showed no association between AR and risk of RA (RR = 0.94; 95% CI, 0.73 to 1.20; I2= 84%). However, when we conducted a sensitivity analysis including only studies with acceptable quality, defined as Newcastle-Ottawa score of seven or higher, we found that patients with AR had a significantly higher risk of RA (RR = 1.36; 95% CI, 1.12 to 1.65; I2= 45%).

Conclusions:The current systematic review and meta-analysis could not reveal a significant association between AR and RA. However, when only studies with acceptable quality were included, a significantly higher risk of RA among patients with AR than individuals without AR was observed.

Keywords:allergic rhinitis; hay fever; meta-analysis; rheumatoid arthritis; systematic review.

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The Association Between Allergic Rhinitis and Risk of Rheumatoid Arthritis: A Systematic Review and Meta-Analysis - DocWire News

News > Clinical Daily News

Early, intensive treatment that combines methotrexate with prednisone can reduce the debilitating fatigue tied to rheumatoid arthritis even in patients at low risk of severe disease, finds a two-year study.

Rheumatoid arthritis causes chronic inflammation that can lead to weakness, exhaustion, and abnormal tiredness in up to 90% of patients, explained researchers from Belgium. Their study examined whether intensive treatment directly after diagnosis could change the disease course and reduce fatigue.

The investigators followed 80 patients with a low risk profile who were randomized into two groups. Immediately following diagnosis, participants received either 15 mg of methotrexate weekly or a combination therapy of 15 mg of methotrexate weekly plus cortisone (prednisone), starting at 30 mg and tapered weekly to 5mg. Both methotrexate and prednisone suppress inflammation, but prednisone is a quicker-acting anti-inflammatory and researchers used it as a bridge between initial treatment and the time the methotrexate took to be effective.

While disease activity in both groups was comparable over time, patients who received the intensive combination therapy for two years were less tired than patients in the monotherapy control group. Differing fatigue levels between the groups became more pronounced over time, the researchers reported.

In response, the European League Against Rheumatism has recommended that clinicians consider initiating early, intensive treatment, even in low-risk patients.

The study was published in Annals of Rheumatic Diseases.

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Early drug therapy eases exhaustion in rheumatoid arthritis patients: study - Clinical Daily News - McKnight's Long Term Care News

A new paper provides timely evidence to explain the therapeutic benefits of vagal nerve stimulation(VNS), a nervous system-modifying treatment that proponents say could offer relief to patients with lupus, arthritis and even heart failure.

Its a prospect that sounds too good to be true. One 20-minute outpatient surgery could lead to relief from epilepsy, depression, arthritis, heart failure and lupus. Thats the ultimate promise of VNSn, a technique that has accrued interest from enthusiastic startups and major biopharma firms alike.

Importantly, it has also accrued some convincing evidence to back up at least some of its claims VNS has been approved by the FDA as a therapy for treatment-resistant depression and epilepsy. As of 2015, 100,000 people worldwide had received a VNS implant.

But large gaps remain in our understanding of how VNS works. One of those gaps has now been plugged with the publication of a paper investigating how a technique called anodal block works to allow targeted stimulation during VNS. The research team behind the paper, led by Dr Stavros Zanos, have published their work in Scientific Reports.

VNS involves implanting electrodes on the vagal nerve near the carotid artery in the neck. The vagal nerve is in charge of routing signals between the brain and the peripheral organs. As Zanos, an assistant professor in the Institute of Bioelectronic Medicine at the Feinstein Institutes for Medical Research, explains, this means it is a uniquely attractive target for neurotechnology. This is primarily the nerve that the brain uses to convey information to the organs and change the way they function. And also, it's the main nerve through which information about the function of the organs is conveyed back into the brain. Because it's such an important nerve for ongoing physiology, it's a very attractive target for neuromodulation, says Zanos.

During VNS implantation, a pair of electrodes is attached to the vagus nerve. Depending on the electrode polarity, signals to or from the brain are stimulated or blocked when the VNS device is activated.

But the nervous system is a little more complicated than a two-lane highway. Nerve fibers sending signals in different directions exist within these larger bundles. Getting the level of stimulation right to ensure therapeutic benefit is of central importance, but is currently done quite crudely, Zanos tells me: The way VNS is done clinically is by increasing intensity. The healthcare provider changes some parameters, most notably the intensity, until the patient starts getting some side effects. Typically, those side effects have to do with contraction of the laryngeal muscles, so it causes coughing, and voice hoarseness.

This is far from optimal, and Zanos says that fine-tuning the approach is a priority. If we wanted to deliver an individualized therapy, we would have to know exactly how we're affecting the physiology of a specific individual, he says.

Anodal block is a central tenet of the current surgical procedure. The precise placement of the VNS electrodes can limit nerve conduction in the fibers under the positively charged anode back in the simplified highway example, this is the equivalent of setting up a tollbooth for traffic going in one direction the flow is slowed, if not stopped. But evidence that anodal block works this way in practice was sorely lacking from the wider literature. Would it be possible to find a biomarker, Zanos wondered, that could show that anodal block works as intended?Zanos and his team investigated this possibility by carrying out experiments with rats. Firstly, they needed to see what would happen when electrical impulses up and down the vagus highway were stopped entirely. The rodents had VNS devices implanted, and then had their vagus nerve cut either above or below the implant completely ending any vagus electrical stimulation towards the brain or the peripheral organs, respectively.

Zanos team noticed a consistent marker. Rats with intact vagus nerves showed a heavy reduction in their breathing and heart rates. When the same rats had their vagus nerve severed near the brain, the rats breathing rates returned to normal whilst the heart rate remained low. Severing the nerve nearer to the body had the opposite effect.

This told Zanos team that:

With these easy-to-measure markers identified, the next step was to work out whether breathing and heart rate were consistently affected by anodal block.The theories behind anodal block suggested that if the anode polarity was towards the brain, then the VNS devices effects on breathing rate would be reduced. Anode polarity facing the body would impair the effects on heart rate.

Whilst the same drastic changes seen in the first experiment were not present the rats in this group had intact vagus nerves, so signals still traveled both ways Zanos noted that their results supported the theories around anode block in a large number of the rats studied.

Importantly, these results werent consistent across all the rats studied. Three rats actually showed reversed effects. This paradox, says Zanos, is likely to be explained by the stimulation of the nearby aortic depressor nerve by the VNS. This unintended stimulation hasnt proved an issue in human VNS studies, so is likely to be a quirk only seen in certain rodents.

Even if the inconsistent data has an explanation, the study still highlights that the mechanisms behind VNS would be much easier to understand if those individual types of nerve fiber could be better identified. Zanos says this will be the target of an upcoming paper that should advance understanding in the area further. In the upcoming paper, says Stavros, We look at even finer relationships between some of these biomarkers; heart rate, breathing rate, but also additional biomarkers with the activation of specific fiber types.

Zanos suggests his teams data supports the idea that anodal block can make VNS more directional and targeted. But there is obviously more research to be done to support our understanding of why VNS works. This, says Zanos, could lead to the technique meeting its potential sooner than we might think. He highlights two US-based companies, LivaNova and Set Point Medical, who are investigating VNS for heart failure and rheumatoid arthritis respectively. My guess is that in the next two or three years at least one of these [companies], based on what I what I see in preliminary reports, will be successful, and VNS will be part of the therapeutic options for physicians for these two diseases.

See the article here:
Vagus Nerve Stimulation Breakthrough Suggests Route To Therapies for Arthritis, Heart Failure - Technology Networks

Plasma omega-3 levels, body mass index (BMI), and smoking history are predictors of treatment response in patients with early rheumatoid arthritis (RA), according to study data published in ACR Open Rheumatology. As such, modification of these lifestyle factors may be beneficial in improving treatment response in this population.

This study enrolled patients with recent-onset RA (disease duration <12 months) who were attending the Early Arthritis Clinic at the Royal Adelaide Hospital in Australia. The researchers aimed to examine lifestyle factors as predictors for treatment response in early RA. Patients with prior exposure to disease-modifying antirheumatic drugs (DMARDs) were excluded.

Enrollees received triple therapy with conventional synthetic DMARDs sulfasalazine, hydroxychloroquine, and methotrexate. Every 3 to 6 weeks, patients returned to the study clinic for evaluation of treatment response. If disease response was subpar at any visit, therapeutic doses were adjusted. A subset of patients received fish oil supplementation in addition to study treatment. Disease activity was evaluated using the 28-joint Disease Activity Score (DAS28) with erythrocyte sedimentation rate (ESR). The primary end points were achievement of remission (DAS28 2.6) or low disease activity (DAS28 3.2) at 1 year.

The study cohort comprised 300 patients, of whom 211 (70.3%) were women. Mean age at RA onset was 55.514.9 years, and median disease duration at enrollment was 16.0 weeks. Mean baseline DAS28 score was 5.41.3, suggesting high disease activity. Of 300 participants, 179 (57.6%) and 136 (43.7%) achieved DAS28 low disease activity and remission at 1 year, respectively.

In the total cohort, higher mean plasma EPA level was associated with a significantly increased likelihood of achieving DAS28 low disease activity (odds ratio [OR], 1.27; 95% CI, 1.12-1.45; P <.0001) and DAS28 remission (OR, 1.21; 95% CI, 1.08-1.36; P <.001) at 1 year. Separate logistic regression models were used to examine 2-way interactions involving BMI, sex, and plasma EPA, but no significant associations were found.

An interaction between smoking status and BMI was observed for the low disease activity outcome. Specifically, increased BMI was associated with lower odds of achieving DAS28 low disease activity among participants who reported current (OR, 0.803; 95% CI, 0.670-0.962; P =.017) and prior smoking (OR, 0.913; 95% CI, 0.842-0.991; P =.029). This association was not apparent among those who had never smoked. BMI alone was also modestly associated with RA remission (OR, 0.94; 95% CI, 0.89-0.99; P =.034).

According to these results, increased omega-3 uptake and smoking cessation may benefit patients with early RA, and weight-loss treatment may also be beneficial, particularly for patients with a history of smoking. As study limitations, the investigators noted the lack of data on potential confounders, including socioeconomic status, physical activity, and medication adherence.

Reference

Brown Z, Metcalf R, Bednarz J, et al. Modifiable lifestyle factors associated with response to treatment in early rheumatoid arthritis [published online May 26, 2020]. ACR Open Rheumatol. doi:10.1002/acr2.11132

See more here:
Omega-3 Levels, Smoking, and BMI Associated With Treatment Response in Early RA - Rheumatology Advisor

The modified Disease Activity Score in 28 joints with C-reactive protein (DAS28-CRP) is a strong predictor of rapid radiographic progression in patients with early rheumatoid arthritis (RA), according to research results published in ACR Open Rheumatology.

Using data from PREMIER, a 2-year, multicenter, double-blind, active comparator-controlled, phase 3 clinical trial, researchers aimed to determine which measures of disease activity best predicted rapid radiographic progression in a population of patients with early RA. They examined the DAS28-CRP; modified DAS28-CRP, using weighted coefficients of CRP, physician global assessment, and swollen joint count in 28 joints; Clinical Disease Activity Index; and patient-reported outcomes, including the patient global assessment and the Health Assessment Questionnaire Disability Index.

Disease activity measures were taken at baseline and at 3-month follow-up. Investigators defined rapid radiographic progression as a change in the modified total Sharp score of >3.5 between baseline and 12 months. A decrease in DAS28-CRP >1.2 from baseline to 3 months was considered an improvement in disease.

In total, 149 patients were included in the analysis (mean age, 52.913.3 years; 75.8% women; mean RA duration, 0.80.9 years; 85.2% rheumatoid factor positive). Mean DAS28-CRP was 6.30.9, mean Clinical Disease Activity Index was 44.712.2, and mean modified DAS28-CRP was 5.11.3. With regard to therapies, 30.9% of patients were previously treated with conventional synthetic disease-modifying antirheumatic drugs, whereas 41.6% of patients were treated with steroids.

At baseline, modified DAS28-CRP was the strongest predictor of rapid radiographic progression at 12 months (adjusted odds ratio [aOR], 3.29; 95% CI, 1.70-6.36); other measures of RA showed no significant effect on progression at 12 months. The area under the curve (AUC) for modified DAS28-CRP at baseline was also higher compared with other measures (AUC, 0.66; 95% CI, 0.57-0.74), with a significant difference noted for AUC between the modified DAS28-CRP and DAS28-CRP (AUC difference, 0.10; P =.02).

At 3 months, investigators found that all disease activity measures and patient-reported outcomes were significant predictors for rapid radiographic progression. Despite this, only modified DAS28-CRP was a significant predictor at 12 months after applying the multivariate analysis and adjusting for potential confounders (aOR, 2.56; 95% CI, 1.43-4.56). Investigators also noted that the effect of modified DAS28-CRP at 3 months was less than its effect at baseline.

Results of a multivariable logistic regression analysis demonstrated that CRP at baseline and 3 months (aORs, 2.82 and 4.03, respectively) had the strongest effect on radiographic progression predictions at 12 months.

Per the Youden index, investigators found that the optimal cutoff point for the modified DAS28-CRP at baseline was 4.5 (positive and negative predictive values 50% and 76%, respectively) in predicting rapid radiographic progression at 1 year. The 3-month corresponding optimal cutoff point for the modified DAS28-CRP was 2.6 (positive and negative predictive values 59% and 81%, respectively).

The study was limited by its relatively small sample size in the original study and an inability to access data from all treatment groups in the PREMIER study.

[A] modified version of disease activity scores, such as the [modified DAS28], might be beneficial as an alternative measure of disease activity for rheumatologists in the routine care setting for their treat-to-target approach, the researchers concluded.

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

Reference

Movahedi M, Weber D, Akhavan P, Keystone EC. Modified disease activity score at 3 months is a significant predictor for rapid radiographic profession at 12 months compared with other measures in patients with rheumatoid arthritis. ACR Open Rheumatol. 2020;2(3):188-194.

Excerpt from:
Modified DAS28-CRP an Effective Predictor of Rapid Radiographic Progression in Early RA - Rheumatology Advisor

The incidence and severity of coronavirus disease 2019 (COVID-19) in patients with rheumatic disease receiving disease-modifying antirheumatic drugs (DMARDs) vs the general population is not significantly different, according to study results published in Arthritis and Rheumatology.

Patients at 2 rheumatology centers in Lombardy, Italy were invited to participate in a survey for the study between February 25t and April 10, 2020. All patients with rheumatic disease were being treated with targeted synthetic or biologic DMARDs (ts/bDMARDs). The survey included data on contact with individuals infected with COVID-19, viral symptoms, and changes in behavior, or disease management; COVID-19 was confirmed by a nasopharyngeal swab.

A total of 955 patients (67.4% women; mean age, 53.714 years) with rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, and other autoinflammatory diseases, were included in the study, with a survey responder rate of 98.05%. A majority of patients were receiving anti-tumor necrosis factor (TNF) therapy (55.8%), with nearly half the patient cohort (47.3%) receiving a bDMARD as monotherapy. A total of 47.3% of patients had 1 comorbidity, mostly high blood pressure.

The survey indicated that 90.6% of patients took precautionary measures to prevent infection with COVID-19; 93.2% of patients maintained their ts/bDMARD treatment regimen, and rheumatic disease activity remained stable in 89.5%. In total, 6 patients with rheumatic diseases tested positive for COVID-19, 5 of whom were treated with anti-TNF agents; 2 patients were receiving bDMARDs as monotherapy.

Researchers observed that the COVID-19 infection rate of patients with rheumatic disease did not differ from the general population (0.62% vs 0.66%; P =.92). While half the number of infected patients (n=3) were admitted to the hospital for oxygen supplementation, none were admitted to the intensive care unit. All patients who tested positive for COVID-19 temporarily discontinued receiving ts/bDMARD therapy during viral infection. An additional 144 patients developed respiratory symptoms; however, they had no access to nasopharyngeal swabs. Of these patients who suspected to have COVID-19, 33 temporarily suspended receiving biologic therapy for an average of 16.9 days, with 9 patients reporting a disease relapse.

A limitation of this study was the cross-sectional survey design. Patients were interviewed by telephone, and it was possible that some symptoms were missed or that nonresponsive patients (n=24) were infected. Furthermore, tests for COVID-19 were unavailable for many patients who were experiencing respiratory symptoms.

Researchers concluded [The] results highlight the attitude [of patients with] rheumatic [disease] to prevent the contagion while maintaining their chronic treatments. The incidence and severity of COVID-19 in patients treated with ts/bDMARDs was not significantly different from that of the general population in the same region.

Reference

Favalli EG, Monti S, Ingegnoli F, Balduzzi S, Caporali R, Montecucco C. Incidence of COVID-19 in patients with rheumatic diseases treated with targeted immunosuppressive drugs: what can we learn from observational data? [published online June 7, 2020] Arthritis Rheum. doi:10.1002/ART.41388

Excerpt from:
Similar Rates of COVID-19 Incidence, Severity in Patients With and Without Rheumatic Disease - Rheumatology Advisor

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Global Rheumatoid Arthritis Treatment Market Latest Trends, Development, Growth Analysis And Forecast by 2027 - Cole of Duty

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Know Future Opportunities of the Rheumatoid Arthritis and Lupus Treatments Market latest Technology, New Innovation, Growing factors with Top Key...

Osteoarthritis pain can be debilitating. Strategies can help get you moving again.

Pain from osteoarthritis is more than just a nuisance. Knee pain, in particular, can not only keep people from exercising, but also have a chilling effect on their ability to participate in social activities, especially those that involve walking or traveling, says Elena Losina, the Robert W. Lovett Professor of Orthopedic Surgery at Harvard Medical School and co-director of the Orthopaedic and Arthritis Center for Outcomes Research at Brigham and Women's Hospital.

"In fact, the quality of life of a person with persistent pain due to knee osteoarthritis is similar to quality of life in women with metastatic breast cancer controlled by therapy," she says.

Arthritis can produce a range of symptoms from pain to stiffness. "The patterns of pain differ from person to person, but it often comes in waves or flares," says Losina. "Also, evolving data show that while pain may fluctuate between flares, a relative minority 10% to 15% of knee osteoarthritis patients experience a steady worsening."

Osteoarthritis is the most common type of arthritis, affecting nearly half of all Americans over 65. It results from the deterioration of the cartilage that acts as a cushion between the bones in a joint. A number of factors can cause cartilage to break down, including general wear and tear from friction and pressure on the joint over time, injuries, and even your genes, as osteoarthritis tends to run in families. Obesity is also a risk factor for osteoarthritis.

As the cartilage padding wears thin, the bones begin to rub together, causing pain and in some cases spurring, an overgrowth of bone as it attempts to heal. All this can lead to inflammation and tissue damage in the surrounding area.

Symptoms of arthritis typically develop over time and may include

Living with arthritis pain can be a challenge, but there are numerous strategies you can use to manage it. There is not yet a treatment that can reverse the underlying joint damage caused by osteoarthritis, Losina says, although several pharmaceutical companies are pursuing disease-modifying agents.

Current treatments for osteoarthritis instead focus on relieving symptoms. They fall into three categories:

Nondrug therapies. These include exercise (one of the most effective treatments currently available) and physical therapy, says Losina. Regular exercise can reduce stiffness, pain, and fatigue. But it can be a challenge to get moving if you aren't exercising regularly already. Try starting off slow, with simple activities such as regular walks.

Drug therapies. Doctors often treat osteoarthritis with nonsteroidal anti-inflammatory drugs, which relieve swelling and pain. Examples include ibuprofen (Advil) and naproxen (Aleve). "There is also evolving research on the role of the antidepressant duloxetine [Cymbalta] and muscle relaxants," says Dr. Losina.

A strategy that has come under scrutiny in recent years is the use of corticosteroid injections to treat pain. This treatment, in which a doctor injects a strong anti-inflammatory medication into the joint, is often used to temporarily relieve pain in people who aren't responding well to other medications or nondrug strategies.

"Recent data suggest that pain control from corticosteroid injections is limited to the short term," says Losina.

These injections may actually lead to more damage to the joint. This means that while you may alleviate pain in the short term, you're making the joint worse in the long term, which could make it harder to control symptoms over time.

Surgery. Joint replacement is sometimes an option for people who aren't seeing success with other strategies. A total knee replacement, for example, can be used to alleviate pain for people with severe knee osteoarthritis.

"It is shown to be effective, leading to substantial pain relief in about four out of five recipients," says Losina. Having this procedure can help many people with severe osteoarthritis regain function in their joint. The replacement can last for 15 to 20 years.

To find the best treatment for your condition, you should discuss your options with a primary care physician or a specialist, such as a rheumatologist, physiatrist, or orthopedic surgeon.

Image: Victor_69/Getty Images

Disclaimer:As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.

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Easing the ache - Harvard Health

Recommended treatments include emollients and intermittent use of topical corticosteroids. For those with moderate-to-severe disease and where topical therapy fails, oral immunosuppressive treatments, for example, prednisolone, ciclosporin, azathioprine and methotrexate are used and while effective, apart from methotrexate, long-term use of oral treatments is not recommended.2 The introduction of the first monoclonal antibody dupilumab, in August 2019, for patients with moderate-to-severe AE was a major treatment advance although a proportion of patients do not achieve a satisfactory response from the drug,3 hence the need for alternative and effective therapeutic options.

In recent years much interest has centred on a new-class of drugs, the Janus kinase inhibitors (JAKis) of which there are three (tofacitinib, baricitinib and upadacitinib) currently licensed for rheumatoid arthritis and psoriatic arthritis (tofacitinib only). The Janus kinase (JAK) pathway facilitates transmission of chemical signals from outside of the cell (that is, once a ligand binds to its receptor) to the nucleus and the subsequent activation of genes involved in a variety of processes such as immune cell division, activation, recruitment and in the context of AE, inflammation. The Janus family consists of four receptor-associated kinases (JAK1, JAK2, JAK3 and TYK2) and a signal transducer and activator of transcription (STAT) pathway. While the precise aetiology of AE remains to be determined, it is characterised by barrier impairment which is thought, in part due to an exaggerated T-helper 2 (Th2) cell response. Keratinocytes activate dendritic and Langerhans cells which subsequently stimulate Th2 cells to produce a range of pro-inflammatory cytokines including interleukin (IL)-4, IL-5, IL-13, IL-31 and IL-33.4 Furthermore, both IL-4 and IL-13 activate the JAK-STAT pathway, leading to the production of pro-inflammatory cytokines5 and through their action on gene expression, downregulate the production of many of the proteins essential for skin-barrier function.6 As a result, JAKis have a potentially important role in attenuating the downstream activation of many different inflammatory cytokines, hence their role in rheumatoid arthritis. However, the recent publication of the results from two Phase III trials, suggest that oral JAKis represent a potentially important new development in the management of moderate-to-severe atopic eczema.

Clinical studiesThe first trial involved baricitinib, which inhibits JAK1 and JAK2. In two identical, double-blind, 16-week, Phase III trials, 1239 adults with moderate-to-severe AE who had failed to adequately respond to topical therapies, received either placebo, or 1, 2 or 4mg oral baricitinib daily.7 Emollients were allowed throughout the trial but any other oral or topical therapies were stopped but permitted as rescue treatment if required. The primary outcomes were an investigator global assessment (IGA) score of 0 (clear) or 1 (almost clear) and a > 2-point improvement from baseline in IGA score. After 16 weeks, 16.8% of patients taking baricitinib 4mg achieved the primary outcome, 11.4% (baricitinib 2mg) and 11.8% (baricitinib 1mg) compared with 4.8% in the placebo group. Baricitinib 4mg was most effective and improvements in itch, sleep disturbance and skin pain were evident after one week of treatment.

The second trial involved abrocitinib (a JAK1 inhibitor) with 391 patients, aged 12 years and over, given the drug at a daily dose of 200mg or 100mg compared with placebo for 12 weeks.8 As in the baricitinib trials, all patients had a documented inadequate response to topical corticosteroids and topical calcineurin inhibitors. The study employed the same primary outcome measures as the baricitinib trials. At the study end, 38.1% of those given abrocitinib 200mg achieved the primary outcome, 28.4% (abrocitinib 100mg) vs 9.1% in the placebo group. As with baricitinib, patients receiving abrocitinib, improvements in signs and symptoms of AE, were apparent within two weeks. Trials of a third agent, upadacitinib, which is also a JAKi, are underway.

In terms of adverse effects, these occurred in up to 58% of patients receiving baricitinib 4mg although no more than 2.5% of these, which included nasopharyngitis and upper respiratory tract infections, were considered as severe. In the abrocitinib trial, 65.8% of those given the 200mg dose experienced an adverse effect, compared to 62.7% in the lower dose group and 53.8% in those taking placebo. The most common adverse effect was nausea in the high dose groups (14.2%), followed by nasopharyngitis (7.7%).

Place in therapyTo date, the information on the efficacy of JAKis in the management of atopic eczema is promising but limited. There are several Phase II studies of other oral and topical JAKis and the results from Phase III studies of these agents are eagerly awaited. Nevertheless, there is a need for studies to assess the longer-term effectiveness of this class of drugs and if there are any important trade-offs between efficacy and safety. None of these agents are currently licensed for the use of atopic eczema and there is an FDA black box warning for the risk of severe infection with baricitinib 2mg (brand name Olumiant) when used for rheumatoid arthritis.9 It is also important to ascertain where this class might sit in the treatment hierarchy. Despite these reservations, it is likely that JAKis represent a potentially useful addition to the treatment armamentarium of doctors managing patients with atopic eczema and their introduction, once it occurs, should be welcomed.

References

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JAK inhibitors: a major advance in the treatment of atopic eczema - Hospital Healthcare Europe

For Immediate Release: June 16, 2020

The U.S. Food and Drug Administration today approved Ilaris (canakinumab) injection for the treatment of Active Stills disease, including Adult-Onset Stills Disease (AOSD). Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

Prior to todays approval, patients had no FDA-approved treatments for their disease, which can include symptoms such as painful arthritis, fevers and rash, said Nikolay Nikolov, M.D., acting director of the Division of Rheumatology and Transplant Medicine in the FDAs Center for Drug Evaluation and Research. Todays approval provides patients with a treatment option.

AOSD is a rare and serious autoinflammatory disease of unknown origin. Autoinflammatory diseases are caused by abnormalities of the immune system, which trigger an inflammatory response that can damage the body's own tissues. Characteristics of AOSD have considerable overlap with Systemic Juvenile Idiopathic Arthritis (SJIA), which includes fever, arthritis, rash and elevated markers for inflammation. The overlapping features of AOSD and SJIA suggest this is a disease continuum rather than two separate diseases.

The role of interleukin-1 (IL-1), a type of cytokine important in regulating the bodys immune system, is well-established in AOSD and SJIA. Ilaris works by blocking the effects of IL-1 and suppressing inflammation in patients with this autoinflammatory disorder. The safety and efficacy of Ilaris for the treatment of patients with AOSD was established using comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with SJIA, as well as the safety of canakinumab in patients with AOSD and other diseases.

Common side effects reported by patients treated with Ilaris are infections (colds and upper respiratory tract infections), abdominal pain and injection-site reactions. The prescribing information for Ilaris includes a warning for potential increased risk of serious infections due to IL-1 blockade. Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Stills disease, and should be aggressively treated. Treatment with immunosuppressants may increase the risk of malignancies. Patients are advised not to receive live vaccinations during treatment.

Ilaris was granted Priority Review designation, under which the FDAs goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

The approval of Ilaris was granted to Novartis Pharmaceuticals Corp.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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06/16/2020

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FDA Approves First Treatment for Adult Onset Still's Disease, a Severe and Rare Disease - FDA.gov

A research team led by Francesca Luca, Ph.D., associate professor of Wayne State Universitys Center for Molecular Medicine and Genetics, has published a study that annotated environmental components that can increase or decrease disease risk through changes in gene expression in 43 genes that could exacerbate or buffer the genetic risk for cardiovascular disease. Their results highlight the importance of evaluating genetic risk in the context of gene-environment interactions to improve precision medicine.

Interpreting Coronary Artery Disease Risk Through GeneEnvironment Interactions in Gene Regulation was published in Genetics, the journal of the Genetics Society of America.

The study, said Dr. Luca, also of the WSU Department of Obstetrics and Gynecology, illustrates that combining genome-wide molecular data with large-scale population-based studies is a powerful approach to investigate how genes and the environment interact to influence risk of cardiovascular disease.

By identifying regions of DNA important for endothelial cell response to different common environmental exposures, the researchers discovered that caffeine can influence the risk of cardiovascular disease. The study demonstrates the potentially beneficial and/or detrimental effects of certain environmental exposures on the cardiovascular disease risk differ depending on individual DNA sequence.

The study focused on cardiovascular disease, Dr. Luca said, because it is the leading cause of death, both in the United States and worldwide. Also, the disease is highly multifactorial, with large contributions from both environmental and genetic risk factors. By treating endothelial cells under a controlled environment, we can discover how these genetic and environmental risk factors influence each other at the molecular level, she said. Our lab has developed expertise in cardiovascular research, with additional projects using endothelial cells to develop new assays to test the regulatory activity of genetic variants. The approach outlined in this paper can be applied to many different diseases; for example, our lab has also focused on how bacteria in the human gut affect gene expression in the colon, and also on the effect of psychosocial stress on asthma.

While the work identified regions of the genome important for how endothelial cells respond to the environment and can influence the risk of cardiovascular disease, the researchers do not yet know exactly which genetic variants are directly responsible. A former graduate student, Cynthia Kalita, developed an assay to test thousands of genetic variants for gene regulatory activity. The researchers can test the variants discovered in their study using that assay to validate and explore the mechanisms by which they exert their effects, Dr. Luca said. They also are developing computational/statistical methods that can yield better personalized risk scores.

We have extended our approach to study cardiomyocytes, which are the muscle cells of the heart. Healthy heart tissue is difficult to obtain, so we have collaborated with researchers at the University of Chicago to derive cardiomyocytes from stem cells, Dr. Luca said. This will allow us to shift our focus from the vasculature to the heart itself, where we can study diseases like cardiomyopathies and arrhythmias.

As the cost of DNA sequencing continues to decrease, Dr. Luca expects that genetic testing will play a greater role in preventive health care. To fully realize the potential of precision medicine, we need to consider both genetic and environmental risk factors of disease, and how they interact. While there are already direct-to-consumer tests that prescribe an individualized diet based on DNA, these products currently offer no demonstrated clinical value. However, with very large numbers of individuals for whom we have both DNA sequencing and information on diet and lifestyle, we may one day be able to offer better recommendations.

Others involved in the study included Anthony Findley, an M.D./Ph.D. student; Allison Richards, Ph.D., a research scientist; Cristiano Petrini, of the Center for Molecular Medicine and Genetics; Adnan Alazizi, lab manager; Elizabeth Doman, of the Center for Molecular Medicine and Genetics; Alexander Shanku, Ph.D., research scientist; Gordon Davis, of the Center for Molecular Medicine and Genetics; Nancy Hauff, Department of Obstetrics and Gynecology; Yoram Sorokin, M.D., professor of Obstetrics and Gynecology; Xiaoquan Wen, of the Department of Biostatistics at the University of Michigan; and Roger Pique-Regi, Ph.D., associate professor of the Center for Molecular Medicine and Genetics, and of the Department of Obstetrics and Gynecology.

Link:
Researchers identify environmental components that affect gene expression in cardiovascular disease - The South End

Precision Medicine Market Size was valued around USD 50 billion in 2018 and is expected to witness lucrative growth from 2019 to 2025.

Rising demand and advancements in cancer biology will augment personalized medicine market during the forecast timeframe. Development of novel genetic technologies that discovers the functional effect of genetic information that leads in developing cancer, thus, should propel huge demand for cancer biology. However, the high price associated with usage of precision medicine may restrict the precision medicine market growth over forecast period.

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On the basis of technology the precision medicine market is segregated into big data analytics, bioinformatics, gene sequencing, drug discovery, companion diagnostics. Rising focus of competitors on producing advanced drugs leading to better treatment for several chronic diseases will drive drug discovery segmental growth. Similarly, rising incidence of chronic as well as respiratory diseases will drive the growth of the market.

Precision medicine market by application is further divided into oncology, immunology, central nervous system (CNS), respiratory diseases. Increasing prevalence of cancer cases and usage of precision medicine in development of new drugs will increase the oncology segmental market growth. Similarly, increasing demand for bioinformatics and big data analytics to set apart human genome data secured from immunological processes augment segmental growth.

On the basis of end users, the precision medicine market is further divided as pharmaceutical companies, diagnostic companies, healthcare IT companies. Rising demand for producing novel tools for rapid integration, storage, and analysis of patient information will drive the business growth.

North America is anticipated to account for the largest share of the Global Precision Medicine Market. Increasing prevalence of cancer across the U.S will augment the growth of the precision medicine market. Similarly, rising healthcare expenditure will drive the growth of precision medicine market over the forecast period. Asia-Pacific is expected to show rapid growth in coming years owing to growing number of investments in R&D activities.

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In this report, we had discussed the market situation of Precision Medicine Market. As we know the world is going to be tech savvy, the demand of trending products and technologies is also increasing. This report can help to understand the business growth in the Precision Medicine Market and new opportunities at new places.

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Global Precision Medicine Market Growth From 2019 to 2025- Market Report, Insights Analysis And Opportunities - Cole of Duty

REDMOND, Wash. June 18, 2020 On Thursday, Microsoft Corp. and Johns Hopkins Medicine (JHM) announced a five-year relationship centered on Microsofts Azure and analytical tools that will support new discoveries as part of JHMs inHealth precision medicine initiative. The work will bring together JHMs leading global research expertise with the power of Microsoft Azure, and its AI capabilities, to help advance JHMs discoveries that will benefit personalized health care. JHM will maintain total control over its data.

inHealth embodies Johns Hopkins commitment to precision medicine, using new tools to understand and manage patients health, informed by their broader health history and environment. This program integrates JHMs longstanding leadership in health care research and delivery with the expertise of the Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Whiting School of Engineering and Johns Hopkins University Applied Physics Lab.

In support of inHealth, JHM has established 16 Precision Medicine Centers of Excellence, where researchers are pursuing breakthroughs in numerous disease settings, such as prostate cancer and multiple sclerosis. JHM aims to have 50 centers in the next five years.

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Ethical use of patient data is a cornerstone of all of JHMs partnerships with patients, including this important work with Microsoft in precision medicine. All projects are compliant with all appropriate privacy regulations, and JHM maintains strict control over all data, including through the use of its Institutional Review Board and its internal Data Trust Council that reviews data use across JHM.

It is a distinct privilege to partner with many of the worlds leading physicians, scientists and engineers at JHM as they use Microsoft Azure and its AI and machine learning capabilities to support some of the most advanced research and breakthroughs in precision medicine, said Gregory Moore, M.D., Ph.D., corporate vice president of Microsoft Health. Im inspired by the collaboration and its bold goals to improve health for all by bringing together some of the worlds best minds in medicine and technology to deliver the future of medical science innovation.

JHM has previously used Microsoft services as JHM developed its pioneering Precision Medicine Analytics Platform (PMAP), a highly innovative data platform that allows collection and analysis information from a broad array of sources in a secure environment. This new agreement will enable inHealth to expand use of other Microsoft resources, such as advanced services, AI, machine learning and analytics.

More information about Johns Hopkins Medicine precision medicine work and inHealth can be found here.

Microsoft (Nasdaq MSFT @microsoft) enables digital transformation for the era of an intelligent cloud and an intelligent edge. Its mission is to empower every person and every organization on the planet to achieve more.

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Microsoft Azure will become the preferred cloud platform for Johns Hopkins in Health precision medicine initiative - DOTmed HealthCare Business News

By Kevin Brown

Precision radiation medicine is a twenty-first century approach to fundamental cancer therapy. Approximately 50-60 percent of cancer patients will receive radiation therapy at some point during their cancer journey, as it is used for curative regimens and palliative care. Radiation therapy has been a pillar of cancer treatment for most of the past century, yet far from being an old or unsophisticated technology, recent advances in radiation delivery technology and software automation have enabled a new era of personalized precision radiation medicine.

The ability to develop personalized radiation therapy regimens is a direct result of the increased precision and accuracy with which cutting-edge systems deliver radiation doses. These systems enable delivery of higher doses of radiation to tumors, which increases efficacy, while reducing exposure of normal tissue, which is essential for improving safety, tolerability and long-term toxicity. The improved targeting to tumors allows more radiation to be delivered during each treatment session, which results in fewer sessions, reduces patients treatment burden, and allows more patients to be treated on each delivery system. Importantly, improved targeting is also opening the door to the use of radiation therapy in hard-to-treat cancers that are not amenable to traditional radiation therapy approaches.

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The challenges of cancer care during the Covid-19 pandemicThe Covid-19 pandemic presents unique and diverse challenges to the safe and effective delivery of cancer care. A key challenge is that many cancer therapies, including chemotherapy and some targeted therapies, are immunosuppressive. Patients treated with these therapies have an increased risk of infection in routine treatment, and these regimens put patients at high risk of infection with SARS-CoV-2, the virus that causes Covid-19. The curtailing of non-emergency surgeries at most hospitals and cancer care centers is also upending standard of care cancer regimens that include surgery.

Link:
Precision radiation medicine and Covid-19: Providing optimal outcomes during extraordinary times - DOTmed HealthCare Business News

NEW YORK, June 18, 2020 /PRNewswire/ --

INTRODUCTIONHarnessing the naturally evolved, medicinal functions of gut bacteria in order to achieve desired clinical outcomes / bene?ts is the core principle behind the rapidly growing field of microbiome therapeutics. In fact, in recent years, promising insights from microbiome focused research has been the cause of much enthusiasm within the medical science community, offering a novel perspective related to personalized medicine. , This particular class of products exists at the interface of naturopathic remedies (considering the active substances that are currently used) and clinically validated interventions, having demonstrated the ability to offer legitimate, quantifiable clinical benefits. Around 200 companies, including both private and public stakeholders, claim to be currently engaged in developing microbiome-based therapies for the treatment of a wide range of diseases. Several large pharmaceutical companies have also demonstrated interest in partnering with early-stage innovators in this domain. , Having said that, most such initiatives are either still in the preclinical stages or early phase clinical trials. There are a few microbiome-based product candidates in phase II/III trials, which are anticipated to drive the market's growth in the short-mid term. According to our estimates, the microbiome-based therapeutics market is projected to be worth over USD 1.5 billion by 2030, growing at an annualized rate of over 30%.

Read the full report: https://www.reportlinker.com/p05915359/?utm_source=PRN

Despite the evident increase in interest in this field, manufacturing live microbial therapeutics remains a largely unaddressed area of concern. In fact, experts believe that the lack of sufficient manufacturing capacity is one of the major impediments to the commercialization of such products. Other challenges include absence of the required industry standards related to manufacturing live biotherapeutics, reproducibility (batch-to-batch consistency) related concerns, lack of expertise and infrastructure to handle anaerobic microbial strains, scaling up existing manufacturing protocols, intellectual property related issues (existing patent law prohibits patenting live organisms and naturally occurring materials) and uncertainties related to regulatory review and product approval. Owing to the aforementioned reasons and several others, such as need for specialized facilities, equipment and operational expertise, innovator companies have begun relying on contract manufacturers for their microbiome-related development and production needs. Outsourcing is known to offer several benefits, which include reductions in capital investment, access to larger production capacities, expediting time-to-market, and commercial risk handling and mitigation (to a significant extent). Presently, a number of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) claim to offer services for manufacturing microbiome-related products. In fact, some have even developed end-to-end capabilities, starting from drug development to regulatory filings, and commercial scale production, in this field.

SCOPE OF THE REPORTThe "Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms, 2020-2030" report features an extensive study of the current landscape and future opportunities related to contract services for microbiome therapeutics. The study features an in-depth analysis, highlighting the capabilities of a diverse set of contract service providers, including CMOs and CDMOs. Amongst other elements, the report includes: A detailed review of the overall landscape of companies offering contract services for manufacturing of microbiome therapeutics, including information on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, type of service(s) offered (strain isolation, media / culture development, fermentation, filtration, lyophilization, fill / finish, cell banking, and analytical services), type of product manufactured (active pharmaceutical ingredients (API) and finished drug formulations (FDF)), type of therapeutic (prebiotics and probiotics), type of drug molecule (small molecules and biologics / live biotherapeutics (LBPs)), type of fermentation (aerobic and anaerobic), type of formulation (solids (tablets / capsules / powders / granules), oral liquids (syrups and solutions), injectables and others), type of primary packaging used (ampoules / vials, blister packing, glass / plastic bottles, pouches / sachets, and others), number and location of manufacturing facilities (country-wise), facility size (if available), as well as their certifications, and company's contact details. A list of companies with in-house manufacturing facilities for microbiome therapeutics along with information on year of establishment, company size, scale of operations (preclinical, clinical and commercial), location of headquarters, and location of manufacturing facilities (country-wise). Elaborate profiles of key industry players (large and mid-sized companies, established before 2000) based in North America, Europe and Asia-Pacific that offer contract manufacturing services for microbiome therapeutics at both clinical and commercial scales. Each profile features a brief overview of the company, microbiome-related service portfolio, information on microbiome manufacturing facilities (if available), and recent developments and an informed future outlook. An informative, regional capability analysis of microbiome contract manufacturers based on supplier strength (which takes into account a company's size and its experience in this field) and service strength (quantified based on type of FDF manufactured, type of primary packaging, type of service(s) offered, scale of operation, number and location of manufacturing facilities), which provides a means to stakeholders for identifying ways to gain a competitive edge in the industry. A list of nearly 50 microbiome-focused drug developers that are anticipated to partner with contract manufacturers and have been shortlisted on the basis of parameters, such as developer strength (which takes into account the company's size and its experience in this field), company's pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and the availability of in-house manufacturing capabilities. A detailed clinical trial analysis of more than 150 completed, ongoing and planned studies of various microbiome therapeutics sponsored by both industry and non-industry players; it highlights prevalent trends across various relevant parameters, such as trial registration year, trial phase, number of patients enrolled, trial recruitment status, study design and trial focus, highlighting leading sponsors (in terms of number of trials conducted), type of organization, popular therapeutic areas, and regional distribution of trials. An estimate of the overall, installed capacity for manufacturing of microbiome therapeutics, taking into consideration the capabilities of various stakeholders, based on data gathered via secondary and primary research; it presents the distribution of available capacity in terms of quantity of microbiome therapeutics produced (in liters, per year), across important market segments, such as company size (small-sized, mid-sized and large companies), scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe and Asia-Pacific and rest of the world). An informed estimate of the annual clinical demand for microbiome therapeutics, taking into account the target patient population in ongoing and planned clinical trials of microbiome therapeutics, sponsored by both industry and non-industry players. A qualitative analysis, highlighting the various factors that need to be taken into consideration by microbiome therapeutics developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO. An analysis of potential market roadmaps and detailed discussion, highlighting various short-term and long-term strategies that can be adopted by microbiome contract manufacturers, in order to expand their respective businesses over the coming years. A review of the varied microbiome-focused initiatives of big pharma players (shortlisted from the top 20 pharmaceutical companies as of 2019), featuring a [A] heat map representation that highlights microbiome therapeutics under development (in partnership with core microbiome-focused entities), along with information on funding, partnership activity, and diversity of product portfolio (in terms of disease indication(s) being treated and focus therapeutic area(s)), and [B] a spider web representation, comparing the initiatives of big pharma players on the basis of multiple relevant parameters.

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the microbiome therapeutics contract manufacturing market. Based on multiple parameters, such as projected growth of the overall microbiome therapeutics market, cost of goods sold and direct manufacturing costs, we developed informed estimates describing the financial evolution of the market, over the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] type of product manufactured (API and FDF), [B] type of formulation (solids (tablets / capsules / powders / granules), oral liquids (syrups and solutions), [C] type of primary packaging used (ampoules / vials, blister packing, glass / plastic bottles, pouches / sachets, and others), [D] company size (very small / small-sized, mid-sized and large / very large), [E] scale of operation (preclinical, clinical and commercial), and [F] key geographical regions, covering North America, Europe, Asia-Pacific, and rest of the world. In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.The opinions and insights presented in this study was influenced by inputs solicited via a survey and discussions held with multiple senior stakeholders in the industry. The report features detailed transcripts of discussions held with the following individuals: Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic) Gaurav Kaushik (Chief Executive Officer and Managing Director, Meteoric Biopharmaceuticals) Assaf Oron (Chief Business Officer, BiomX) Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies) Debbie Pinkston (Vice President, Sales and Business Development, List Biological Laboratories) JP Benya (Vice President, Business Development, Assembly Biosciences) Rob van Dijk (Business Development Manager, Wacker Biotech) Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGYThe data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include: Annual reports Investor presentations SEC filings Industry databases News releases from company websites Government policy documents Industry analysts' viewsWhile the focus has been on forecasting the market till 2030, the report also provides our independent view on technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINESChapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the microbiome therapeutics contract manufacturing market and its likely evolution in the short-mid term and long term.

Chapter 3 provides a general introduction to the human microbiome, along with information on the various types of microbiome therapeutics. It also features an elaborate discussion on the functions of the microbiota, emphasizing on the key insights generated from the Human Microbiome Project (HMP). Further, the chapter also includes a description of the various steps that are involved in the manufacturing of microbiome therapeutics. In addition, it highlights the challenges associated with manufacturing such products and the growing need for outsourcing in this domain. Finally, it provides a list of key factors that need to be considered by innovator companies while selecting a CMO partner.

Chapter 4 provides an overview of the microbiome contract manufacturing landscape. It includes information on over 40 contract manufacturers that claim to offer microbiome therapeutics manufacturing services. In addition, it features an in-depth analysis of these companies, based on a number of parameters, such as on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, type of service(s) offered (strain isolation, media / culture development, fermentation, filtration, lyophilization, fill / finish, cell banking, and analytical services), type of product manufactured (active pharmaceutical ingredients (API) and finished drug formulations (FDF)), type of therapeutic (prebiotics and probiotics), type of drug molecule (small molecules and biologics / live biotherapeutics (LBPs)), type of fermentation (aerobic, anaerobic, and genetically modified organisms), type of formulation (solids (tablets / capsules / powders / granules), oral liquids (syrups and solutions), injectables and others), type of primary packaging used (ampoules / vials, blister packing, glass / plastic bottles, pouches / sachets, and others), number and location of manufacturing facilities (country-wise), facility size (if available), as well as their certifications, and company's contact details. A list of companies with in-house manufacturing facilities for microbiome therapeutics along with information on year of establishment, company size, scale of operations (preclinical, clinical and commercial), location of headquarters, and location of manufacturing facilities (country-wise).

Chapter 5 includes detailed profiles of key industry players (large and mid-sized companies established before 2000) based in North America, Europe and Asia-Pacific that offer contract manufacturing services for microbiome therapeutics at both clinical and commercial scales. Each profile features a brief overview of the company, microbiome-related service portfolio, information on microbiome manufacturing facilities (if available), and recent developments and an informed future outlook

Chapter 6 features an informative regional capability analysis of microbiome contract manufacturers based on supplier strength (which takes into account a company's size and its experience in this field) and service strength (quantified based on type of FDF manufactured, type of primary packaging, type of service(s) offered, scale of operation, number and location of manufacturing facilities), which provides a means to stakeholders for identifying ways to gain a competitive edge in the industry.

Chapter 7 features a list of nearly 50 microbiome-focused drug developers that are anticipated to partner with contract manufacturers and have been shortlisted on the basis of parameters, such as developer strength (which takes into account a company's size and its experience in this field), company's pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and the availability of in-house manufacturing capabilities.

Chapter 8 provides a detailed clinical trial analysis of more than 150 completed, ongoing and planned studies of various microbiome therapeutics sponsored by both industry and non-industry players; it highlights prevalent trends across various relevant parameters, such as trial registration year, trial phase, number of patients enrolled, trial recruitment status, study design and trial focus, highlighting leading sponsors (in terms of number of trials conducted), type of organization, popular therapeutic areas, and regional distribution of trials.

Chapter 9 features an estimate of the overall, installed capacity for manufacturing of microbiome therapeutics, taking into consideration the capabilities of various stakeholders, based on data gathered via secondary and primary research; it presents the distribution of available capacity in terms of quantity of microbiome therapeutics produced (in liters, per year), across important market segments, such as company size (small-sized, mid-sized and large companies), scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe and Asia-Pacific and rest of the world).

Chapter 10 features an informed estimate of the annual clinical demand for microbiome therapeutics, taking into account the target patient population in ongoing and planned clinical trials of microbiome therapeutics, sponsored by both industry and non-industry players.

Chapter 11 presents a qualitative analysis that highlights the various factors that need to be taken into consideration by microbiome therapeutics developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

Chapter 12 features an analysis of potential market roadmaps and detailed discussion, highlighting various short-term and long-term strategies that can be adopted by microbiome contract manufacturers, in order to expand their respective businesses over the coming years.

Chapter 13 a review of the varied microbiome-focused initiatives of big pharma players (shortlisted from the top 20 pharmaceutical companies as of 2019), featuring a [A] heat map representation that highlights microbiome therapeutics under development (in partnership with core microbiome-focused entities), along with information on funding, partnership activity, and diversity of product portfolio (in terms of disease indication(s) being treated and focus therapeutic area(s)), and [B] a spider web representation, comparing the initiatives of big pharma players on the basis of multiple relevant parameters.

Chapter 14 features an elaborate market forecast analysis, highlighting the likely growth of microbiome contract manufacturing market till the year 2030. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] type of product manufactured (API and FDF), [B] type of formulation (solids (tablets / capsules / powders / granules), oral liquids (syrups and solutions), [C] type of primary packaging used (ampoules / vials, blister packing, glass / plastic bottles, pouches / sachets, and others), [D] company size (very small / small-sized, mid-sized and large / very large), [E] scale of operation (preclinical, clinical and commercial), and [F] key geographical regions, covering North America, Europe, Asia-Pacific, and rest of the world. In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.Chapter 15 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 16 is a collection of interview transcripts of discussions held with various key stakeholders in this market. The chapter provides a brief overview of the companies and details of interviews held with Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic), Gaurav Kaushik (Managing Director and Chief Executive Officer, Meteoric Biopharmaceuticals), Assaf Oron (Chief Business Officer, BiomX), Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies), Debbie Pinkston (Vice President, Sales and Business Development, List Biological Laboratories), JP Benya (Vice President, Business Development, Assembly Biosciences), Rob van Dijk (Business Development Manager, Wacker Biotech), and Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical).

Chapter 17 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 18 is an appendix, which contains the list of companies and organizations mentioned in the report.

Chapter 19 is an appendix, which contains the list of companies that claim to offer contract manufacturing for probiotic supplements.

Read the full report: https://www.reportlinker.com/p05915359/?utm_source=PRN

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Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms,...

SAN FRANCISCO--(BUSINESS WIRE)--IncellDx announces the patent filing with the USPTO and the Pre-EUA with the FDA for CCL5/RANTES Utility as a Diagnostic, Prognostic, and Therapeutic Biomarker in COVID-19. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of a novel coronavirus disease 2019 (COVID-19), is now a global pandemic. Growing information has demonstrated that a dysregulated and/or hyper-immune response causes a cytokine storm with massive increases in cytokines and chemokines which leads to infiltration of immune cells in multiple organs driving the significant co-morbidity and mortality in severe COVID-19. CCL5/RANTES is a chemokine that binds to the chemokine receptor CCR5. CCR5 is expressed on immune cells such as T-lymphocytes, macrophages, and NK cells. CCL5/RANTES acts like a magnet for these cells expressing CCR5. Thus CCL5/RANTES is a marker for the early stages of immune dysregulation in COVID-19 and as a possible therapeutic marker to determine when and how long therapy targeting CCR5 or RANTES should be continued. Other Cytokines included in the COVID-19 Cytokine Panel can be used to monitor other COVID-19 therapeutic approaches targeting other cytokines involved in the cytokine storm.

Dr. Bruce Patterson, chief executive officer of IncellDx, commented, When we were developing a cytokine quantification assay for possible COVID trials in China, we discovered that infected patients had consistently high levels of CCL5/RANTES in plasma which in some cases was 100 times normal depending on the severity of the disease. Other reports in the literature demonstrated that CCL5/RANTES can be elevated in renal failure, liver failure, coagulopathies, and in Kawasakis disease, all co-morbidities seen in COVID-19. Therapies targeting CCR5 are currently in trials against COVID-19 and we are extremely excited about filing an initial inquiry with the FDA concerning the potential use of a battery of companion tests to monitor the efficacy of drugs in the fight against this virus. It makes sense that we have diagnostics for the presence or absence of virus, exposure to the virus, and the next round of diagnostics should be personalized medicine approaches to determining the efficacy of COVID-19 therapies.

Dr Patterson is the primary author of the pre-print Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19 currently undergoing peer review.

Company files Pre-EUA with FDA for CCR5 receptor occupancy and a COVID cytokine panel including IL-6, IL-8,TNF-a, GM-CSF, and CCL5/RANTES.

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IncellDx Files Patent for CCL5/RANTES Utility as a Diagnostic, Prognostic, and Therapeutic Biomarker in COVID-19 and Other Cytokine Storm Conditions -...