StemCell Therapy

Among patients with newly diagnosed rheumatoid arthritis (RA), Disease Activity Score 28-joint count (DAS28) characterized using C-reactive protein (CRP) values are lower than the corresponding score using erythrocyte sedimentation rate (ESR) values, both at baseline high disease activity and post-treatment, according to study results published in ACR Open Rheumatology.

Disease activity scores are used to guide treatment and determine the efficacy of therapeutic strategies. Previous studies have shown that DAS28-CRP values are lower than DAS28-CRP values, but current guidelines do not provide specific cutoffs for high disease activity for each of the scores.

Existing studies that compared DAS28-CRP and DAS28-ESR used data from patients who received immunosuppressive therapy. The objective of the current study was to compare the scores from immunosuppressive treatment-nave patients.

The retrospective electronic chart review included 171 immunosuppressive treatment-nave patients with newly diagnosed RA. DAS28-CRP and DAS28-ESR were compared according to the cutoff value for baseline high disease activity (>5.1). A receiver operator characteristic curve (ROC) and Youden index were used to calculate the DAS28-CRP high disease activity optimal cut-point value corresponding to DAS28-ESR >5.1.

At baseline, the mean DAS28-ESR was higher than the mean DAS-28 CRP (5.1 1.2 vs. 4.1 1.0; P <.001) and more patients met high disease activity criteria for DAS28-ESR than for DAS28-CRP (48.5% vs. 14.6%, respectively). ROC curve and Youden index analysis showed that the cutoff point estimation of high disease activity using DAS28-ESR >5.1 corresponded to a DAS28-CRP score <4.06 (area under the ROC curve = 0.93, P =.000).

Data on both DAS28-ESR and DAS28-CRP score following treatment were available for 151 patients. On average, DAS28-CRP values were 0.66 points higher than the corresponding DAS28-ESR. DAS28-CRP values were significantly lower compared with DAS28-ESR in all subgroups classified by gender, age, and disease severity.

In patients in remission (values <2.6), mean DAS28-CRP values were 0.36 points lower than the corresponding DAS28-ESR value (1.45 vs. 1.81, respectively).

The study had several limitations, including the racially homogeneous cohort (91.8% white), single center study, as well as lack of data on body mass index or comorbidities which may have a significant impact on the difference between DAS28-ESR and DAS28-CRP.

There is a difference between DAS28-ESR and DAS28-CRP, even when calculated for immunosuppressive treatmentnave patients. DAS28-CRP is significantly lower than DAS28-ESR, wrote the researchers.

Greenmyer JR, Stacy JM, Sahmoun AE, Beal JR, Diri E. DAS28-CRP cutoffs for high disease activity and remission are lower than DAS28-ESR in rheumatoid arthritis. ACR Open Rheumatol. 2020;2(9):507-511. doi:10.1002/acr2.11171

More:
Comparing DAS28-ESR and DAS28-CRP in Patients with Rheumatoid Arthritis - Rheumatology Advisor

Gilead Sciences rheumatoid arthritis (RA) treatment Jyseleca has been given a recommendation from the UKs National Institute of Health and Care Excellence (NICE).

Jyseleca (filgotinib) is an oral JAK inhibitor that can be administered as a monotherapy or used alongside another another common RA medicine called methotrexate.

Patients with moderate-to-severe RA will now be able to access the drug on the NHS in England, if they have responded inadequately to previous intensive therapy with two or more disease-modifying anti-rheumatic drugs (DMARDs).

This is a landmark decision from NICE and represents a pivotal moment for the treatment of RA, said James Galloway, consultant rheumatologist at Kings College London Hospital.

While no single medicine works for everyone, the addition of Jyseleca is an important step forward that we believe will help more patients achieve remission, even when their disease is at a less advanced stage, he added.

In phase 3 trials, Jyseleca was shown to be effective in reducing the symptoms of RA, including joint tenderness and swelling.

In one of these studies FINCH 1 the JAK inhibitor was compared to AbbVies TNF antibody Humira(adalimumab) or placebo given on top of methotrexate in patients with moderate-to-severe RA who werent responding to methotrexate alone.

Daily oral dosing with Jyseleca was significantly better than placebo in achieving a 20% improvement in symptoms (an ACR 20 response), the primary endpoint in the study, and matched the efficacy of Humira which is given by injection.

FINCH 3 compared Jyseleca alone or in combination with methotrexate as a front-line therapy for patients with moderate-to-severe RA. In this study, the combination was significantly better than methotrexate alone at helping patients achieve an ACR20 response.

In addition, Jyseleca monotherapy was as effective as methotrexate on the ACR20 measure, but was significantly better on the 50% improvement (ACR50) and 70% improvement (ACR70) scales.

In August 2020, the US Food and Drug Administration (FDA) rejected Gileads Jyseleca, handing the company a complete response letter (CRL).

In this CRL, the FDA asked for data from two ongoing clinical trials MANTA and MANTA-Ray investigating the effect of the 200mg dose of Jyseleca on sperm concentrations.

The FDA has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose, Gilead added in a statement.

Topline results from the MANTA and MANTA-Ray studies are expected in the first half of 2021, at which point Gilead is likely to refile Jyseleca with the FDA.

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Gilead's Jyseleca is given a NICE recommendation for rheumatoid arthritis - PMLiVE

Background:Although targeted biological treatments have transformed the outlook for patients with rheumatoid arthritis, 40% of patients show poor clinical response, which is mechanistically still unexplained. Because more than 50% of patients with rheumatoid arthritis have low or absent CD20 B cells-the target for rituximab-in the main disease tissue (joint synovium), we hypothesised that, in these patients, the IL-6 receptor inhibitor tocilizumab would be more effective. The aim of this trial was to compare the effect of tocilizumab with rituximab in patients with rheumatoid arthritis who had an inadequate response to anti-tumour necrosis factor (TNF) stratified for synovial B-cell status.

Methods:This study was a 48-week, biopsy-driven, multicentre, open-label, phase 4 randomised controlled trial (rituximab vs tocilizumab in anti-TNF inadequate responder patients with rheumatoid arthritis; R4RA) done in 19 centres across five European countries (the UK, Belgium, Italy, Portugal, and Spain). Patients aged 18 years or older who fulfilled the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria for rheumatoid arthritis and were eligible for treatment with rituximab therapy according to UK National Institute for Health and Care Excellence guidelines were eligible for inclusion in the trial. To inform balanced stratification, following a baseline synovial biopsy, patients were classified histologically as B-cell poor or rich. Patients were then randomly assigned (1:1) centrally in block sizes of six and four to receive two 1000 mg rituximab infusions at an interval of 2 weeks (rituximab group) or 8 mg/kg tocilizumab infusions at 4-week intervals (tocilizumab group). To enhance the accuracy of the stratification of B-cell poor and B-cell rich patients, baseline synovial biopsies from all participants were subjected to RNA sequencing and reclassified by B-cell molecular signature. The study was powered to test the superiority of tocilizumab over rituximab in the B-cell poor population at 16 weeks. The primary endpoint was defined as a 50% improvement in Clinical Disease Activity Index (CDAI50%) from baseline. The trial is registered on the ISRCTN database, ISRCTN97443826, and EudraCT, 2012-002535-28.

Findings:Between Feb 28, 2013, and Jan 17, 2019, 164 patients were classified histologically and were randomly assigned to the rituximab group (83 [51%]) or the tocilizumab group (81 [49%]). In patients histologically classified as B-cell poor, there was no statistically significant difference in CDAI50% between the rituximab group (17 [45%] of 38 patients) and the tocilizumab group (23 [56%] of 41 patients; difference 11% [95% CI -11 to 33], p=031). However, in the synovial biopsies classified as B-cell poor with RNA sequencing the tocilizumab group had a significantly higher response rate compared with the rituximab group for CDAI50% (rituximab group 12 [36%] of 33 patients vs tocilizumab group 20 [63%] of 32 patients; difference 26% [2 to 50], p=0035). Occurrence of adverse events (rituximab group 76 [70%] of 108 patients vs tocilizumab group 94 [80%] of 117 patients; difference 10% [-1 to 21) and serious adverse events (rituximab group 8 [7%] of 108 vs tocilizumab group 12 [10%] of 117; difference 3% [-5 to 10]) were not significantly different between treatment groups.

Interpretation:The results suggest that RNA sequencing-based stratification of rheumatoid arthritis synovial tissue showed stronger associations with clinical responses compared with histopathological classification. Additionally, for patients with low or absent B-cell lineage expression signature in synovial tissue tocilizumab is more effective than rituximab. Replication of the results and validation of the RNA sequencing-based classification in independent cohorts is required before making treatment recommendations for clinical practice.

Funding:Efficacy and Mechanism Evaluation programme from the UK National Institute for Health Research.

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Rituximab versus tocilizumab in anti-TNF inadequate responder patients with rheumatoid arthritis (R4RA): 16-week outcomes of a stratified,...

PIPis designed to aid people with extra costs associated with long-term health conditions, or disabilities. The sum is set at a weekly rate, and people will be able to obtain varying amounts dependent on how their condition affects them. PIP is tax-free, though, and Britons can receive the sum whether they are in work or out of work.

PIP as a payment from the Department for Work and Pensions (DWP), could therefore provide assistance to those with arthritis or a range of other conditions.

Arthritis is common within the UK, and is a condition which causes pain and inflammation in the joints.

The NHS estimates more than 10 million people currently have arthritis or other similar joint conditions, across the country.

Of these, then, many could stand to benefit from a PIP payments to assist them with their day-to-day lives.

READ MORE:Cold Weather Payment: DWP triggers new postcodes - 25 payout due

Those who are over state pension age who wish their PIP to continue, are urged to renew their claim when their current award draws to a close.

A PIP payment, though, is not dependent on the condition a person has, rather how it affects them on a day-to-day basis.

The sum is comprised of two parts - the daily living part and the mobility part.

Whether a person receives one or both of these payments and how much they will ultimately receive will depend on the severity of their condition.

However, to receive PIP there is a claims process one will have to go through with the DWP.

People who think they may be eligible for a payment are encouraged to reach out to the DWP via phone.

Alternatively, individuals may be able to get a PIP claim form sent to them by post, where they will be required to fill out details about their condition and how it affects them.

Individuals will need certain information to hand, including:

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PIP: Britons could claim up to 151 a week for arthritis or other conditions - Express

Sure, the cat never really moved around all that much in the first place. But now kitty stays in one spot for long periods of time and looks stiff when she does eventually move.

The signs point to arthritis, says the German Association for Animal Health. Changes in behaviour can be a first hint.

If you think your feline friend has arthritis, its time for a trip to the vet, who can prescribe a suitable pain medication if it is indeed the case; unfortunately, there is no cure.

Owners can do a bit to make life for their kitty a bit more comfortable: A bigger litter box with a low entrance can help, as can making the path to its favourite spots more accessible.

If possible, the cat should be encouraged to carefully keep active, and owners need to keep an eye on their kittys weight: Fewer kilos mean less stress on the joints. Theres also the option of supporting joint metabolism with a special diet. dpa

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Cats can get arthritis and here are the first signs to look out for - The Star Online

Photo: Contributed

The Spotlight series is a series of articles looking at common, and preventable, diseases.

I explain the science behind the condition, how to spot early signs and what you can do to prevent it.

The Science

Arthritis refers to a multitude of conditions that cause inflammation and pain in the joints. Arthritis can be split into osteoarthritis and inflammatory arthritis, such as rheumatoid arthritis.

One in five Canadians live with arthritis; it is common in older age, although young people can also suffer from it.

Osteoarthritis is the most common form of arthritis, and also the most preventable. It is caused by joint damage that occurs over time with aging, or due to injury.

Osteoarthritis causes a loss of cartilage, which is the material that covers and protects the bones.

Without cartilage, the bones grind against one another, causing pain, swelling and stiffness. The joints most commonly affected by osteoarthritis are the knees, hips, hands and spine.

Inflammatory arthritis is a collective term for all the other types of arthritis.

Common examples are:

Inflammatory arthritis not only affects the joints, but also other systems in the body. They are caused by autoimmune disorders, where the bodys immune system attacks the tissue in and around the joint.

This causes pain, stiffness and swelling, as well as systemic symptoms like fevers, weight loss and fatigue.

Signs and Symptoms

All types of arthritis cause pain, stiffness and swelling of one or more joints. The symptoms can change during the day, and also with exercise and rest. Typically, cold weather also worsens symptoms.

Eventually, this can lead to reduced mobility.

How to Prevent Arthritis

Many factors affecting your risk of arthritis cannot be controlled, such as your genetics and gender. However, some factors can be prevented.

If you have a strong family history of arthritis, its worth going to your family doctor to discuss your risk. Be mindful of the signs and symptoms, as getting treatment early can make a big difference.

In terms of preventing arthritis, the most important factor is maintaining a healthy weight. Being overweight puts excess force through your joints with each step you take, increasing the wear and tear on the joint and ultimately causing long term damage.

Maintaining a healthy weight for your height is crucial in preventing arthritis.

As well as eating healthily to maintain a good weight, getting regular exercise is ideal. The best form of exercise for preventing arthritis is a mix of cardiovascular and strength training; for instance, try alternating swimming or cycling with weight training.

This strengthens your body without putting too much stress on any one joint.

As well as the injury from excess weight, other injuries to your joints can increase your risk of arthritis.

Be careful when exercising and playing sports, and remember to always warm up and cool down to reduce your risk of an injury. If appropriate, consider joint supports if you do have an existing injury.

You can also reduce your risk of injury by being careful lifting heavy objects, sitting in an ergonomic position if you work at a desk and using a backpack to carry heavy items, rather than carrying items on one arm.

If you are concerned about an existing injury or the possibility of one, speak to your family doctor or physiotherapist.

Take Home Message

Although some factors are out of your control, there is plenty that you can do to reduce your risk of arthritis.

It can be a debilitating disease, so getting plenty of exercise, eating well and maintaining a healthy weight are ways that you can significantly reduce your risk of the disease.

Be mindful of any existing injuries, and look after your joints to prevent any new ones.

Link:
Spotlight on: Arthritis - Health and Happiness - Castanet.net

Shares of Aclaris Therapeutics Inc. ACRS, +192.35% skyrocketed more than 200% toward a 2 1/2-year high, on massive volume, in midday trading Tuesday, after the biopharmaceutical company announced "positive" data from a Phase 2a trial of its rheumatoid arthritis treatment. The stock shot up 211.1%, putting it on track for the highest close since July 2018, to pace all gainers on major U.S. exchanges. Trading volume soared to 79.7 million shares, compared with the full-day average of about 859,000 shares. The company said the Phase 2a multicenter trial was randomized, patient-blind, sponsor-unblinded and placebo-controlled, and the primary endpoint was safety and tolerability of ATI-450, an investigational oral MK2 inhibitor. In the trial, the company said ATI-450 as generally well tolerated, showed no serious adverse events and demonstrated durable clinical activity. Aclaris Chief Medical Officer David Gordon said he believes the data supports the hypothesis that MK2 inhibition is an important novel target for treating immuno-inflammatory diseases, and he looks forward to progressing ATI-450 to Phase 2b. The stock has soared more than four-fold (up 305.5%) over the past three months, while the iShares Nasdaq Biotechnology ETF IBB, +1.75% has rallied 19.4% and the S&P 500 SPX, +0.80% has gained 10.6%.

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Aclaris Therapeutics stock more than triples after 'positive' data on arthritis treatment trial - MarketWatch

DEAR DR. ROACH: I would like to know how to treat arthritis. I have been using Voltaren per my doctors orders, but it does not seem to be helping much. I have also been taking ibuprofen, but I am afraid of stomach bleeding. The arthritis is in my wrists and thumb. I can hardly open a doorknob or lift any small objects. Does turmeric help?

I would appreciate any advice you can give me. It is hard to do any cooking or housework using my hands. They ache and throb all day. M.V.

ANSWER: There are several different types of arthritis of the hand, and it sounds as though your doctor has made the diagnosis of osteoarthritis, which is the most common type. Rheumatoid arthritis and psoriatic arthritis are inflammatory varieties that require very different therapies. Blood testing and X-rays help separate the different types of arthritis from one another if your history and physical exam indicate the need.

If you have osteoarthritis, oral anti-inflammatory medicines like Voltaren or ibuprofen (but NEVER both taking two different NSAIDs orally adds only toxicity, not effectiveness) are common and often effective treatments. Voltaren is also available as a gel, and its OK to use both Voltaren gel and a different oral NSAID such as ibuprofen. The gel is poorly absorbed into the body and is very unlikely to have systemic side effects.

However, remember that exercise improves pain and function. One set of exercises specifically for hand arthritis from the Mayo Clinic can be found at tinyurl.com/mayo-hand.

You asked about turmeric. There are studies showing benefit for turmeric and it has little toxicity, so I think it is worth a try. Similarly, Boswellia supplements have shown benefit in some people with osteoarthritis.

DEAR DR. ROACH: I tested positive for COVID-19 about six weeks ago. I had very mild symptoms for about 24 hours. I lost my sense of taste and smell. My senses are slowly returning, but now I constantly have a strange taste in my mouth. I cant tell if its a metallic taste or not. Eating, drinking, chewing gum, brushing, etc., make it go away for 10 minutes. Is this COVID-related or something else? Will it go away? -- M.R.

ANSWER: While I cant answer with certainty, many people with COVID-19 have disturbances in taste and smell that take weeks or months to resolve. Based on my experience with these patients, I would guess your disturbance is most likely COVID-19 related, and is likely to go away in time.

Dr. Roach regrets that he is unable to answer individual letters, but will incorporate them in the column whenever possible. Readers may email questions to ToYourGoodHealth@med.cornell.edu or send mail to 628 Virginia Dr., Orlando, FL 32803.

Read more here:
Arthritis treatment needed for pain in hands - Northeast Mississippi Daily Journal

Machine learning was shown to identify patients with rheumatoid arthritis (RA) who present an increased chance of achieving clinical response with sarilumab, with those selected also showing an inferior response to adalimumab, according to an abstract presented at ACR Convergence, the annual meeting of the American College of Rheumatology (ACR).

In prior phase 3 trials comparing the interleukin 6 receptor (IL-6R) inhibitor sarilumab with placebo and the tumor necrosis factor (TNF-) inhibitor adalimumab, sarilumab appeared to provide superior efficacy for patients with moderate to severe RA. Although promising, the researchers of the abstract highlight that treatment of RA requires a more individualized approach to maximize efficacy and minimize risk of adverse events.

The characteristics of patients who are most likely to benefit from sarilumab treatment remain poorly understood, noted researchers.

Seeking to better identify the patients with RA who may best benefit from sarilumab treatment, the researchers applied machine learning to select from a predefined set of patient characteristics, which they hypothesized may help delineate the patients who could benefit most from either antiIL-6R or antiTNF- treatment.

Following their extraction of data from the sarilumab clinical development program, the researchers utilized a decision tree classification approach to build predictive models on ACR response criteria at week 24 in patients from the phase 3 MOBILITY trial, focusing on the 200-mg dose of sarilumab. They incorporated the Generalized, Unbiased, Interaction Detection and Estimation (GUIDE) algorithm, including 17 categorical and 25 continuous baseline variables as candidate predictors. These included protein biomarkers, disease activity scoring, and demographic data, added the researchers.

Endpoints used were ACR20, ACR50, and ACR70 at week 24, with the resulting rule validated through application on independent data sets from the following trials:

Assessing the end points used, it was found that the most successful GUIDE model was trained against the ACR20 response. From the 42 candidate predictor variables, the combined presence of anticitrullinated protein antibodies (ACPA) and C-reactive protein >12.3 mg/L was identified as a predictor of better treatment outcomes with sarilumab, with those patients identified as rule-positive.

These rule-positive patients, which ranged from 34% to 51% in the sarilumab groups across the 4 trials, were shown to have more severe disease and poorer prognostic factors at baseline. They also exhibited better outcomes than rule-negative patients for most end points assessed, except for patients with inadequate response to TNF inhibitors.

Notably, rule-positive patients had a better response to sarilumab but an inferior response to adalimumab, except for patients of the HAQ-Disability Index minimal clinically important difference end point.

If verified in prospective studies, this rule could facilitate treatment decision-making for patients with RA, concluded the researchers.

Reference

Rehberg M, Giegerich C, Praestgaard A, et al. Identification of a rule to predict response to sarilumab in patients with rheumatoid arthritis using machine learning and clinical trial data. Presented at: ACR Convergence 2020; November 5-9, 2020. Accessed January 15, 2021. 021. Abstract 2006. https://acrabstracts.org/abstract/identification-of-a-rule-to-predict-response-to-sarilumab-in-patients-with-rheumatoid-arthritis-using-machine-learning-and-clinical-trial-data/

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Machine Learning Shown to Identify Patient Response to Sarilumab in Rheumatoid Arthritis - AJMC.com Managed Markets Network

This article was originally published here

J Rheumatol. 2021 Jan 15:jrheum.201226. doi: 10.3899/jrheum.201226. Online ahead of print.

ABSTRACT

OBJECTIVE: Both erectile dysfunction (ED) and rheumatoid arthritis (RA) are associated with increased cardiovascular risk. It is unknown if these diagnoses are associated or if their combination confers additional cardiovascular risk. We aim to define the incidence of ED in RA, and determine if ED correlates with increased cardiovascular risk in RA.

METHODS: Medical information concerning RA, ED and cardiovascular diagnoses for men with RA (n=260) diagnosed in Olmsted county, Minnesota and age-matched male comparators was extracted from a comprehensive medical record system.

RESULTS: ED incidence was similar between the RA cohort and comparators (HR 0.80; 95% CI 0.55-1.16). In men with RA, ED diagnosis was associated with a trend toward an increase in peripheral arterial disease (HR 2.22; 95% CI 0.98-5.03) and a significantly decreased rate of myocardial infarction (HR 0.26; 95% CI 0.07-0.90), heart failure (HR 0.49; 95% CI 0.25-0.94) and death (HR 0.56; 95% CI 0.36-0.87). In men with RA and ED, phosphodiesterase-5 inhibitor use was associated with a decreased risk of death (HR 0.35; 95% CI 0.16-0.79), with a trending decreased risk of some cardiovascular diagnoses.

CONCLUSION: Incidence of ED was not statistically increased in RA. Although patients with both RA and ED had a similar overall cardiovascular risk to those with RA alone, men with both RA and ED had decreased risk of heart failure, myocardial infarction and death, as well as an increased risk of peripheral arterial disease. Further studies are needed to clarify these associations and their implications for pathogenesis and therapeutics.

PMID:33452166 | DOI:10.3899/jrheum.201226

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Erectile Dysfunction and Cardiovascular Risk in Men with Rheumatoid Arthritis: A Population- Based Cohort Study - DocWire News

Two arthritis drugs, tocilizumab and sarilumab, have re-emerged as possible treatment options for Covid-19 with the UK government recommending their use based on a new study. The use of arthritis drugs, especially tocilizumab, against coronavirus has been the subject of debate through the pandemic, emerging as a choice at times and falling out of favour at other times. The latest study, which is on a preprint server (which means that it is yet to be peer-reviewed), its results unlike those of previous trials suggest that tocilizumab and sarilumab could help save lives among Covid-19 patients admitted to an intensive care unit (ICU).

The study

Last week, the portal MedRxiv published results of the REMAP-CAP trial, which assessed 803 Covid-19 patients in ICU. Of them, 353 were administered tocilizumab within 24 hours of ICU admission, another 48 were given sarilumab within the same time-frame, and the remaining 402 were administered standard care minus these two drugs (the control arm).

While 64.2% ICU patients survived in the control arm, 72% survived when administered tocilizumab and 77.8% survived when given sarilumab.

The researchers found that the two arthritis drugs, now repurposed for Covid treatment, also helped reduce the need for organ support. Those given tocilizumab required organ support after 10 days on an average, those on sarilumab required after 11 days, and those in the control arm required organ support system in a single day.

What this could mean

This trial shows the drugs cannot be written off so easily, said Dr Shashank R Joshi, who has been part of another study to assess arthritis drug itolizumabs role in Covid-19 treatment. Joshi said despite multiple trial studies yielding unfavourable conclusions for immunosuppressants use against Covid-19, they have found tocilizumab (marketed as Actemra by Roche) effective if used at the correct time. In clinical practice we have observed that if a patient is on high flow nasal cannula and put on steroids, and if his condition deteriorates within next 24 hours in ICU, an immunosuppressant drug can be the correct intervention at that point. We have seen several patients turn around towards recovery, Joshi said.

In India, three immunosuppressant drugs tocilizumab, sarilumab, and itolizumab are used to treat rheumatoid arthritis. These drugs work against a protein called IL-6, which plays a key role in the body mounting a cytokine response (when the immune system attacks the bodys own cells) after the virus infects the body. By suppressing IL-6, these repurposed drugs are supposed to stop the self-damaging cytokine response in severe Covid-19 infections.

Red flags

The Indian Council of Medical Research has previously warned against indiscriminate use of drugs such as remdesivir and tocilizumab in Covid-19 patients as they can do more harm than good. Four months before the UK approved use of the arthritis drugs, Maharashtra had removed tocilizumab from its Covid-19 treatment protocol. Several trials and studies had led to this decision. The most crucial one came from tocilizumab manufacturer Roche in July 2020: it published phase-III trial results that found tocilizumab did not meet the primary endpoint of clinical improvement or the secondary endpoint of reduction in mortality.

In October 2020, the New England Journal of Medicine published a study on 243 patients that found tocilizumab was not effective in preventing death in moderately ill, hospitalised Covid-19 patients.

In September 2020, pharma giant Sanofi halted its trial on sarilumab stating it did not work against Covid-19 after testing it on 420 patients. That July, Sanofi had halted a similar trial in the US after assessing 194 patients. In fact, Sanofi had said sarilumab was associated with a 3% higher risk of adverse events in comparison to the placebo group.

Unsettled debate

Why are the latest findings so contradictory? Intensivist Dr Rahul Pandit, who was himself treated with tocilizumab for Covid-19 last year, said he has completely stopped use of the drug. We cannot rush into a conclusion with this one new research. We need to look at bigger data, Pandit said.

Pandit stopped use of tocilizumab and itolizumab five months ago. There was no evidence of improvement or reduction in mortality. Patients are at risk of secondary infection with this drug, he said.

But as Dr Joshi puts it, Each clinical trial has a different yardstick to measure the endpoint. This is only a year-old illness. We need to wait for more data before writing off drugs.

See original here:
Now out of favour, now back: arthritis drugs in Covid-19 treatment - The Indian Express

About 374,000 Canadians live with rheumatoid arthritis which affects their joins and puts them at higher risk for other health problems. (ljubaphoto/iStock)

People who have been diagnosed with rheumatoid arthritis have an increased risk of cardiovascular disease and infection. Researchers at Arthritis Research Canada have found that they also have a higher risk of developing life threatening blood clots.

Rheumatoid arthritis (RA) occurs when the bodys immune system mistakenly attacks the lining of the joints and other tissues causing swelling, pain, and stiffness. It can affect almost all organ systems and cause such things as cardiovascular problems, infections, depression and gastrointestinal ulcers. About 1.2 per cent of Canadian aged 16 and older live with the condition. It affects more women than men.

For this study, the researchers investigated the risk of blood clots that start in a vein and can travel to the lungs and blood clots in veins of the leg. These kinds of clots (VTE) affect more than one in 1,000 people in Western populations each year.

Dr. Antonio Avia-Zubieta says the higher risk of blood clots must be taken into account in treating patients diagnosed with rheumatoid arthritis. (Sombilon Studios)

The study found that the risk of VTE was highest in the first year after patients are diagnosed with rheumatoid arthritis. The risk decreases progressively as patients are treated for the inflammation associated with arthritis but it is still significantly higher five years later.

These findings have important implications for clinical care, both immediately after a rheumatoid arthritis diagnosis and in long-term treatment as treating inflammation decreases the risk, said Antonio Avia-Zubieta, a rheumatologist and senior scientist of rheumatology at Arthritis Research Canada. Clinicians should be aware that RA causes patients to have a higher risk not only of heart attacks and strokes, but also VTE, particularly in the period soon after diagnosis.

The study was published in the journal Rheumatology.

Arthritis Research Canada is the largest clinical research institution in North America.

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Rheumatoid arthritis patients at higher risk of dangerous blood clots: study - Radio Canada International - English Section

The Global Rheumatoid Arthritis Treatment Market report provides a holistic evaluation of the market for the forecast period (20192025). The report comprises various segments as well as an analysis of the trends and factors that are playing a substantial role in the market. These factors; the market dynamics involve the drivers, restraints, opportunities and challenges through which the impact of these factors in the market are outlined. The drivers and restraints are intrinsic factors whereas opportunities and challenges are extrinsic factors of the market. The Global Rheumatoid Arthritis Treatment Market study provides an outlook on the development of the market in terms of revenue throughout the prognosis period.

In order to present an executive-level model of the market and its future perspectives, the Rheumatoid Arthritis Treatment Market report presents a clear segmentation based on different parameters. The factors that affect these segments are also discussed in detail in the report.

Rheumatoid arthritis (RA) is the most common autoimmune arthritis affecting more than 1.3 million U.S. citizens (American College of Rheumatology). More surprising is to know that around 75% of this affected population is women. Affecting the joints at any age, rheumatoid arthritis needs to be addressed early to avoid expensive joint replacement surgery. While it can affect any joint, small joints in hand and feet tend to be affected the most. Treatments available for rheumatoid arthritis aids to relive symptoms and improve the joint function. A comprehensive treatment for RA usually involves integration of patient education, exercise, medications, and surgery (occasionally).

Major Players included in this report are as follows Pfizer, Inc., Johnson & Johnson, Abbvie, Inc., F. Hoffmann-La Roche AG, Merck & Co., Inc., and Amgen, Inc.,

Get PDF Brochure Of This Research Report @ https://www.coherentmarketinsights.com/insight/request-pdf/166

Rheumatoid Arthritis Treatment Market: Regional analysis includes:

The study will also feature the key companies operating in the industry, their product/business portfolio, market share, financial status, regional share, segment revenue, SWOT analysis, key strategies including mergers & acquisitions, product developments, joint ventures & partnerships an expansions among others, and their latest news as well. The study will also provide a list of emerging players in the Rheumatoid Arthritis Treatment Market.

Rheumatoid Arthritis Treatment Market scope

A basic summary of the competitive landscape A detailed breakdown of the regional expanse A short overview of the segmentation

Furthermore, this study will help our clients solve the following issues:

Cyclical dynamics We foresee dynamics of industries by using core analytical and unconventional market research approaches. Our clients use insights provided by us to maneuver themselves through market uncertainties and disruptions.

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Some of the Major Highlights of TOC covers:

Rheumatoid Arthritis Treatment Regional Market Analysis

Rheumatoid Arthritis Treatment Production by Regions Global Rheumatoid Arthritis Treatment Production by Regions Global Rheumatoid Arthritis Treatment Revenue by Regions Rheumatoid Arthritis Treatment Consumption by Regions

Rheumatoid Arthritis Treatment Segment Market Analysis (by Type)

Global Rheumatoid Arthritis Treatment Production by Type Global Rheumatoid Arthritis Treatment Revenue by Type Rheumatoid Arthritis Treatment Price by Type

Rheumatoid Arthritis Treatment Segment Market Analysis (by Application)

Global Rheumatoid Arthritis Treatment Consumption by Application Global Rheumatoid Arthritis Treatment Consumption Market Share by Application (2014-2019)

Rheumatoid Arthritis Treatment Major Manufacturers Analysis

Rheumatoid Arthritis Treatment Production Sites and Area Served Product Introduction, Application and Specification Rheumatoid Arthritis Treatment Production, Revenue, Ex-factory Price and Gross Margin (2014-2019)Main Business and Markets Served

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Rheumatoid Arthritis Treatment Market With Focus On Growth Analysis, Production, Consumption, Revenue, Analysis By 2026 | Pfizer, Inc., Johnson &...

Rheumatoid arthritis and pregnancy: Heres what women with RA need to know  |  Photo Credit: iStock Images

New Delhi: Pregnancy is a beautiful phase in a womans life. But what if you have a condition like rheumatoid arthritis (RA), you may have a number of questions, including how it will affect your pregnancy and the babys development. And theres another vital question - will I be able to care for my new baby.

If you have rheumatoid arthritis and are pregnant or planning to become pregnant, its important to know how RA and pregnancy can affect each other. Rheumatoid arthritis is a chronic inflammatory disorder that affects many joints, including those in the hands and feet. It may strike women in their mid-twenties and early 30s, aprimary time period when a woman plans her pregnancy. In this article, Dr Singhai Shweta, consultant - rheumatology- Sakra World Hospital, Bengaluru, tells us how rheumatoid arthritis could affect pregnancy and what women can do to manage their condition, which will enable them a healthy pregnancy and a healthy baby.

It has been observed that most pregnant women with RA have low disease activity during pregnancy and may get remission by the third trimester. However, among few women with severe disease activity, the condition can lead to several complications like preterm birth, raised blood pressure or preeclampsia, low birth weight babies and increased possibility of C-section delivery. Thus, those with controlled RA certainly have healthier pregnancies and babies than those with worse disease activity.

Rheumatoid arthritis may cause low birth weight babies. Also, about 3 per cent to 5 per cent of newborns to mothers with acute RA may have birth defects. This happens due to certain antirheumatic drugs that may mess up with the foetal formation. This is why a woman with RA must essentially consult a doctor before planning a pregnancy.

Things a pregnant mom with RA must keep in mind:

A majority of pregnant women, as much as 60 per cent, experience improvement in their symptoms due to a number of reasons, such as:

Managing rheumatoid arthritis is extremely essential for a healthy pregnancy and a healthy baby. Heres what women can do to manage RA effectively:

Also, stay away from foods that may cause a flare-up: Identify the foods that may worsen the condition and avoid them to prevent a flare-up.

Disclaimer: Tips and suggestions mentioned in the article are for general information purposes only and should not be construed as professional medical advice. Always consult your doctor or a professional healthcare provider if you have any specific questions about any medical matter.

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Rheumatoid arthritis and pregnancy: Heres what women with RA need to know - Times Now

Getting dressed, brushing teeth, opening a jar to make a meal: many Canadians can take performing these tasks for granted. But for those living with osteoarthritis in their hands, the gripping and twisting motions of daily life are a regular source of pain and frustration.

It can affect everything. Living with pain certainly has an impact, but it extends to all dimensions of life, said Joy MacDermid, professor of physical therapy and co-director of the clinical research lab at the Roth | McFarlane Hand and Upper Limb Centre.

There are also economic implications if work is affected, as well as increased risk for isolation and depression. We often hear from people whove had to give up things they value, like participating in sports, or doing crafts they used to enjoy, said MacDermid. Those activities are related to their social life and often done with friends.

Joy MacDermid, PhD

She and her colleagues are working on improving the quality of life for those living with hand osteoarthritis by studying the force used in daily tasks to develop new joint protection programs. Her research, done with the assistance of Pavlos Bobos, PhD20, and in collaboration with engineering professors Louis Ferreira and Emily Lalone through Westerns Bone and Joint Institute, has received recognition from the Arthritis Society as one of its Top 10 Research Advances of 2020.

Pavlos Bobos, PhD

Louis Ferreira, PhD

Emily Lalone, PhD

Joint protection programs a group of strategies to decrease strain on the joints have included training patients to do tasks differently, to use assistive devices or to pace high-force activities like carrying a heavy laundry basket throughout the day.

Until now, these programs have been based on theory alone, MacDermid said. Weve always thought if you put your joint in a neutral position, it makes sense biomechanically that it would lessen force through the joints, but we didnt have measurements demonstrating that joint protection worked. We needed devices to do that.

Thats where Ferreiras and Lalones expertise in mechanical and material engineering, and specifically wearable technology, comes in. Ferreira designed a sensor allowing Lalone and her graduate students to measure, in real time, the forces in fingertips when performing functional tasks. Tiny strain gauges attached to the nailbed pick up a recording when the finger is depressed.

Sensors embedded in finger sleeves measured the force of daily tasks.

The first design saw the sensor embedded in fake fingernails, then evolved through the teams investigations to be worn in small finger sleeves by test subjects in MacDermids lab.

We had a kitchen area set up and a series of standardized tasks that patients would go through, such as pouring a tea kettle or lifting a cup, she said. Patients were tested, first doing tasks their own way, then repeating them using joint protection strategies. The subjects were videotaped, and data on the amount of movement and force used for each task was analyzed.

Early results showed some strategies are very effective in reducing the amount of force going through the joint, but there were also unexpected observations. There seems to be some tasks that people naturally gravitate toward doing correctly, MacDermid said. For example, patients knew inherently how to lift a kettle in the best way to avoid strain. But with other tasks they had no idea when they were doing it incorrectly.

Biofeedback, in the form of an audio or visual cue while doing a task, could help patients avoid joint strain in the future, the study found.

This is part of MacDermids long-term vision, made possible through the transdisciplinary effort fostered through the Bone and Joint Institute.

We first want to create an intervention where people would wear the sensors in the clinic and get feedback, she said. But in the long-term, as sensor technology develops and becomes more stable, were hoping we can give people a kit that gives them feedback when they practise the tasks in their own home for two or three weeks.

Shes hoping her work will also influence updates to patient training materials, noting some still suggest using a pencil rather than a finger to dial a rotary phone. The tasks people do today and the types of assistive devices we have to help people now are so different.

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Combined forces help combat the pain and disability of arthritis - Western News

Background:The effect of mannose-binding lectin (MBL) gene polymorphisms on susceptibility of rheumatoid arthritis (RA) were evaluated in ethnically different populations, whereas the results were always inconsistent.

Materials and methods:Fourteen articles involving 36 datasets were recruited to evaluate the association between MBL gene polymorphisms and rheumatoid arthritis in a meta-analysis. The random or fixed effect models were used to evaluate the pooled odds ratios (ORs) and their corresponding 95% confidence intervals (CIs).

Results:Stratified analysis by ethnicities was conducted and the result revealed that rs1800450 (T vs C, OR = 1.32, 95% CI: 1.04-1.67, P < .05) and MBL-A/O (T vs C, OR = 1.20, 95% CI: 1.08-1.34, P < .001) were strongly associated with RA in Brazilian populations. In addition, the significant relationship between rs11003125 (T vs C, OR = 1.16, 95% CI: 1.06-1.26, P < .05) with RA were also observed in East Asian populations. Meanwhile, the inverse associations between rs5030737 with RA in East Asians and rs1800450 with RA in Indians were acquired. However, no association between any MBL polymorphism with RA susceptibility was confirmed in Caucasians.

Conclusions:The structural polymorphisms in exon 1 of MBL gene may significantly contribute to susceptibility and development of RA in Brazilian and Indian populations, whereas the functional polymorphisms in the promoter region were more likely to associate with RA in East Asians.

Keywords:mannose-binding lectin; meta-analysis; polymorphism; rheumatoid arthritis.

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Effect of mannose-binding lectin gene polymorphisms on the risk of rheumatoid arthritis: Evidence from a meta-analysis - DocWire News

Objectives: To investigate whether low social support or low decision latitude at work correlate with risk of rheumatoid arthritis (RA), and whether and how those factors are associated with known modifiable risk factors for RA.

Method: The Swedish population-based EIRA study included, from 1996 to 2015, 3724 incident RA cases and 5935 controls, matched for age, gender, and residential area. Participants filled in detailed questionnaires at diagnosis. Using logistic regression, we investigated whether low social support and low decision latitude at work were associated with RA risk, and whether and how these exposures are associated with known modifiable risk factors for RA.

Results: Low decision latitude at work was associated with RA risk in unadjusted analyses [odd ratio (OR) = 1.52, 95% confidence interval (CI) = 1.20-1.94], but this association was weakened after adjustment for known RA risk factors (adjusted OR = 1.24, 95% CI = 0.93-1.63). Low social support was not associated with RA risk (unadjusted OR = 1.05, 95% CI = 0.95-1.15). Cases reporting low decision latitude were more often smokers (OR = 2.05, 95% CI = 1.33-3.16), without university degrees (OR = 8.23, 95% CI = 5.13-13.22), and more often female (OR = 2.52, 95% CI = 1.66-3.81), with a similar pattern among controls. Cases reporting low social support were more often men (OR = 1.60, 95% CI = 1.40-1.83), smokers (OR = 1.46, 95% CI = 1.26-1.70), obese (OR = 1.29, 95% CI = 1.09-1.54), physically inactive (OR = 2.78, 95% CI = 1.98-3.90), and without university degrees (OR = 2.04, 95% CI = 1.77-2.36), with a similar pattern among controls.

Conclusion: Low decision latitude coexisted with several known environmental/social risk factors for RA, together defining groups of individuals at increased risk of RA. These risk factors should be viewed in context when testing actions to diminish RA risk in prospective studies.

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Social stressors and risk of rheumatoid arthritis and their relationship to known modifiable risk factors: results from the Swedish EIRA study -...

Objective:RA is associated with higher risk of cardiovascular (CV) disease. Ongoing systemic inflammation is presumed to accelerate atherosclerosis by increasing inflammation in the arterial wall. However, evidence supporting this hypothesis is limited. We aimed to investigate arterial wall inflammation in RA vs OA, and its association with markers of inflammation and CV risk factors.

Methods:18-fluorodeoxyglucose PET combined with CT (18F-FDG-PET/CT) was performed in RA (n = 61) and OA (n = 28) to investigate inflammatory activity in the wall of large arteries. Secondary analyses were performed in patients with early untreated RA (n = 30), and established RA, active under DMARD treatment (n = 31) vs OA.

Results:Patients with RA had significantly higher 18F-FDG uptake in the wall of the carotid arteries (beta 0.27, 95%CI 0.11-0.44, P <0.01) and the aorta (beta 0.47, 95%CI 0.17-0.76, P <0.01) when compared with OA, which persisted after adjustment for traditional CV risk factors. Patients with early RA had the highest 18F-FDG uptake, followed by patients with established RA and OA respectively. Higher ESR and DAS of 28 joints values were associated with higher 18F-FDG uptake in all arterial segments.

Conclusion:Patients with RA have increased 18F-FDG uptake in the arterial wall compared with patients with OA, as a possible marker of early atherosclerosis. Furthermore, a higher level of clinical disease activity and circulating inflammatory markers was associated with higher arterial 18F-FDG uptake, which may support a role of arterial wall inflammation in the pathogenesis of vascular complications in patients with RA.

Keywords:FDG PET/CT; RA; atherosclerosis; inflammation.

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Arterial wall inflammation is increased in rheumatoid arthritis compared with osteoarthritis, as a marker of early atherosclerosis - DocWire News

VERSUS Arthritis, the UKs leading charity for people with arthritis, has appointed Dr Neha Issar-Brown as its new Director of Research.

Neha joins from Fight for Sight where she was Director of Research, Policy and Innovation, supporting pioneering research to prevent sight loss. She also initiated the framework for the charitys first patient-centred research strategy.

In her new role, Neha will be responsible for developing Versus Arthritis own research strategy, aimed at making sure that research discoveries are rapidly translated into life-changing treatments for people with arthritis, along with ensuring that the level of investment in arthritis research reflects the prevalence of a condition that impacts one in six people in the UK.

Her previous roles include Head of Population Health and System Medicine at the UKRIs Medical Research Council (MRC).

Neha will be taking up her new position in February and said:

I am thrilled to be joining Versus Arthritis at this exciting time in the development of its research strategy.

I am particularly excited about working for an organisation that has such a strong track record in putting people with arthritis at the heart of its work, ensuring that no decision is made without the involvement of those who will be directly impacted.

Im looking forward to becoming part of an amazing team and to driving progress for millions of people with arthritis.

Ellen Miller, Deputy Chief Executive of Versus Arthritis, said:

Were delighted to welcome Neha to Versus Arthritis at such a significant time.

The COVID-19 pandemic and Brexit have put a huge strain on medical research charities, but with Nehas breadth of experience alongside our incredible partners and supporters, were in a very good position to build on and continue supporting world-leading research that will fundamentally change the lives of people with arthritis.

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Versus Arthritis appoints new director of research - Charity Today News

DUBLIN--(BUSINESS WIRE)--The "Rheumatoid Arthritis - Global Drug Forecast and Market Analysis to 2029" report has been added to ResearchAndMarkets.com's offering.

Global revenues from RA drug sales are expected to grow from $26.2B in 2019 to $29.1B in 2029.

The publisher projects that the global RA marketplace - which, for the purposes of this report, comprises eight major pharmaceutical markets (8MM) (US, France, Germany, Italy, Spain, UK, Japan, and Australia) - will grow at a compound annual growth rate (CAGR) of 1.0% over the 10-year forecast.

Global growth in the RA market will be driven by continued uptake of new products in the IL-6 and JAK inhibitor classes along with the anticipated approval and launch of four pipeline therapies. This growth will be slackened by sales erosion from biosimilars and generic tofacitinib. Over 70% of sales will come from the US; the US has a large population of RA patients (estimated 1.8M diagnosed prevalent cases in 2029) and high price tags for biologic and targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).

Biosimilar erosion will temper the growth of the RA market during the forecast period; between 2019 and 2029, biosimilars sales will increase from 5% to 28% of global sales. Due to favorable local regulations and increased access, biosimilar uptake is expected to be the highest in the 5EU; by 2029, the publisher projects that biosimilar sales in 5EU will represent over 45% of its total sales -60% of which will come from sales of adalimumab and etanercept biosimilars.

The publisher expects that despite biosimilar erosion, Pfizer/Amgen's Enbrel and AbbVie's Humira will remain the global sales leaders during the forecast period, amassing combined sales of $12.6B in 2019 and $9.0B in 2029. Sales of Enbrel and Humira are more likely to be protected from biosimilar erosion than Remicade (negative CAGR of 6.8%) mainly due to a lack of biosimilar availability in the US, the largest RA market in the 8MM. Etanercept and adalimumab biosimilars will not be available in the US until 2028 and 2023, respectively.

Although biosimilars may temper the impact of blockbuster biologics, the publisher expects that the growth of the small molecule Janus kinase (JAK) inhibitor class will powerfully shape the RA market of the future. The publisher projects that the JAK inhibitor class will continue to grow significantly over the forecast period, increasing at a CAGR of 7.2%. This growth is expected to be strongest in the 5EU, where the first JAK inhibitors, Pfizer's Xeljanz and Eli Lilly's Olumiant, only became available starting in 2017. The recent global launch of AbbVie's JAK1 inhibitor, Rinvoq, is expected to significantly expand JAK inhibitor market share, bringing in $2.2B in sales by 2029.

The late-stage pipeline for RA consists of three subcutaneously delivered biologics (the TNF inhibitor ozoralizumab, the interleukin 6 [IL-6] inhibitor olokizumab, and the granulocyte-macrophage colony-stimulating factor [GM-CSF] inhibitor otilimab) and one oral kinase inhibitor (the BTK inhibitor fenebrutinib). Key opinion leaders (KOLs) expressed measured enthusiasm for these agents-they welcomed the potential availability of new mechanisms of action but did not think that any of them would be more or even equally effective as JAK inhibitors.

Of these agents, KOLs were the most enthusiastic about GSK's GM-CSF inhibitor, otilimab, expected to achieve global sales of $626.8M by 2029. All together, these four pipeline agents are expected to claim less than 5% of the RA market in 2029, equivalent to about $1.1B.

Key Topics Covered:

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Rheumatoid Arthritis: Executive Summary

2.1 Biosimilar and Generic Erosion Will Stymie Sales Growth in the RA Market from 2019-2029

2.2 Development of Novel Oral Agents and Biosimilars Are Popular R&D Strategies

2.3 Opportunities Remain for More Rapid, Targeted, and Cost-Effective Treatment for RA Patients

2.4 Late-Stage RA Pipeline Holds Promise But Likely Won't Match the Utility of JAK Inhibitors

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology

4.2 Pathophysiology

4.3 Symptoms and Severity Classifications

5 Epidemiology

5.1 Risk Factors and Comorbidities

5.2 Global and Historical Trends

5.3 Forecast Methodology

5.4 Epidemiological Forecast for RA (2019-2029)

5.5 Discussion

6 Disease Management

6.1 Diagnosis and Treatment Overview

6.2 US

6.3 5EU

6.4 Japan

6.5 Australia

7 Competitive Assessment

7.1 Overview

7.2 Biosimilars in the RA Market

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Earlier Diagnosis and Treatment

8.3 Cost-Effective Therapies

8.4 Personalized Treatment Strategies

8.5 Improved Guidance on Treating RA Patients in Remission

8.6 New Treatment Options for Patients with Refractory RA

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.3 Other Drugs in Development - Kinase Inhibitors

10. Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Portfolio Assessments

11. Market Outlook

11.1 Global Markets

11.2 US

11.3 5EU

11.4 Japan

11.5 Australia

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/ba8mff

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Global Rheumatoid Arthritis (RA) Market Analysis & Drug Forecasts, 2019-2020 & 2029 - Biosimilar and Generic Erosion Will Stymie Sales Growth...