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Archive for the ‘Arthritis’ Category

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

Wednesday, February 3rd, 2021

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Wednesday, January 27th, 2021

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

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

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

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

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

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

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

About Psoriatic Arthritis and Ankylosing Spondylitis

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

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

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

About SELECT-PsA 12,4

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

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

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

About SELECT-PsA 22,5

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

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

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

About SELECT-AXIS 12,6

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

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

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

About RINVOQ(upadacitinib)

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

Important Safety Information about RINVOQ (upadacitinib)1

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

Use in combination with other potent immunosuppressants is not recommended.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

About AbbVie in Rheumatology

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

About AbbVie

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

Forward-Looking Statements

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

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

References

SOURCE AbbVie

abbvie.com

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

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

Wednesday, January 27th, 2021

BY KEITH ROACH, M.D.

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

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

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

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

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

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

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

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

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UK-based Ampersand Health rolls out My Arthritis DTx – Mobihealth News

Wednesday, January 27th, 2021

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

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

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

HIMSS20 Digital

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

WHY IT MATTERS

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

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

THE LARGER TREND

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

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

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

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

Wednesday, January 27th, 2021

Introduction

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

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

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

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

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

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

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

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

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

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

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

Box 1 Compliance Questionnaire in Rheumatology

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

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

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

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

Table 1 Baseline Characteristics of Patients

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

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

Table 2 Association of Study Variables with Treatment Adherence

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Wednesday, January 27th, 2021

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

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

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

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

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

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

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

Wednesday, January 27th, 2021

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

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

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Gilead’s Jyseleca is given a NICE recommendation for rheumatoid arthritis – PMLiVE

Wednesday, January 27th, 2021

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

Wednesday, January 27th, 2021

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

Wednesday, January 27th, 2021

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

Wednesday, January 27th, 2021

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

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Spotlight on: Arthritis – Health and Happiness – Castanet.net

Wednesday, January 27th, 2021

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

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Aclaris Therapeutics stock more than triples after ‘positive’ data on arthritis treatment trial – MarketWatch

Tuesday, January 19th, 2021

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

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Arthritis treatment needed for pain in hands – Northeast Mississippi Daily Journal

Tuesday, January 19th, 2021

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.

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Arthritis treatment needed for pain in hands - Northeast Mississippi Daily Journal

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

Tuesday, January 19th, 2021

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

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

Tuesday, January 19th, 2021

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

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

Tuesday, January 19th, 2021

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.

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

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

Tuesday, January 19th, 2021

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

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

Tuesday, January 19th, 2021

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.,

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Rheumatoid Arthritis Treatment Market: Regional analysis includes:

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Rheumatoid Arthritis Treatment Market scope

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Rheumatoid Arthritis Treatment Regional Market Analysis

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

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

Tuesday, January 19th, 2021

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

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