Oral Treatment Option for RA Includes Tofacitinib (XELJANZ®) Plus Methotrexate

MedicalResearch.com Interview with:

Roy Fleischmann, MD MACR Medical Director Metroplex Clinical Research Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX 75231

Dr. Fleischmann

Roy Fleischmann, MD MACR
Medical Director
Metroplex Clinical Research Center
Clinical Professor of Medicine
University of Texas Southwestern Medical Center
Dallas, TX 75231

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In the phase 3 studies of tofacitinib, it was noted that the clinical responses to tofacitinib monotherapy were higher than the responses to tofaciotinib plus MTX and that tofacitinib plus methotrexate had numerically higher clinical responses compared to adalimumab plus methotrexate. This study was a non-inferiority design which compared tofacitinib monotherapy to tofacitinib + MTX and to adalimumab +MTX and tofacitinib monotherapy to tofacitinib +MTX in MTX incomplete responders. It was found that tofacitinib + MTX is non-inferior to adalimumab + MTX (and vice versa) and neither was superior to the other. The results of tofacitinib to either combination was non-conclusive showing neither non-inferiority or inferiority, but suggesting that either combination will be effective in more patients in a group of patients.

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Increased Cardiovascular Risk in Rheumatoid Arthritis Comparable to Diabetes

MedicalResearch.com Interview with:
Prof.dr. M.T. Nurmohamed, MD, PhD
and
Rabia Agca MD
Dept. of Rheumatology | VU University Medical Center
Amsterdam Rheumatology & immunology Center
EULAR center of excellence in rheumatology

MedicalResearch.com: What is the background for this study?

Response: About 20 years ago the increased mortality in rheumatoid arthritis (RA) was well known, but not the causes. In daily clinical practice it seemed that RA patients more frequently suffered from myocardial infarctions than general population persons. Therefore, we started this study more than 15 years ago as at that time there were only sparse data with respect to cardiovascular morbidity in rheumatoid arthritis.

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High Intensity Statins Linked To Lower Risk of Rheumatoid Arthritis

MedicalResearch.com Interview with:

Marie Hudson, MD MPH FRCPC Jewish General Hospital and Lady David Research Institute Montreal, QC

Dr. Marie Hudson

Marie Hudson, MD MPH FRCPC
Jewish General Hospital and Lady David Research Institute
Montreal, QC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Statins are widely used to treat hypercholesterolemia. In addition to their effect on cholesterol levels, statins also attenuate inflammation and have immunomodulatory properties. Whether this translates into meaningful differences in health outcomes, though, remains uncertain. We therefore undertook this study to determine whether people exposed to high doses of statins were at a lower risk of developing rheumatoid arthritis compared to those at lower doses. We studied a large population-based cohort of over half a million people exposed to statins for the first time and followed them on average for 3 years.

We found that those exposed to the highest intensity statin quintile had a 33% lower risk of developing rheumatoid arthritis compared to those in the lowest intensity quintile (adjusted HR 0.77; 95% CI: 0.63-0.95). We conducted several additional secondary analyses that all pointed in the same direction and suggested that statins reduce the risk of rheumatoid arthritis.

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Non–TNF-Targeted Biologic Found Superior to Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient Response to a First Anti-TNF Drug

MedicalResearch.com Interview with:
Jacques-Eric Gottenberg, MD, PhD Department of Rheumatology National Reference Center for Systemic Autoimmune Diseases Strasbourg University Hospital, Université de Strasbourg Strasbourg, FranceJacques-Eric Gottenberg, MD, PhD
Department of Rheumatology
National Reference Center for Systemic Autoimmune Diseases
Strasbourg University Hospital, Université de Strasbourg
Strasbourg, France

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is no recommendation for the choice of the second biologic in patients with rheumatoid arthritis and insufficient response to a first anti-TNF, which is a common situation in our daily practice (approximately one third of patients treated with anti-TNF). We therefore conducted the first randomized trial to date to investigate the best strategy in such a setting.

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Gut Bacteria May Play Role in Rheumatoid Arthritis Activity

MedicalResearch.com Interview with:

Veena Taneja, Ph.D Immunologist Mayo Clinic Rochester MN

Dr. Veena Taneja

Veena Taneja, Ph.D
Immunologist
Mayo Clinic
Rochester MN

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Gut bacteria have been suggested to be involved in pathogenesis of rheumatoid arthritis. We used new technology to sequence the bacteria in patients with rheumatoid arthritis and first degree relatives and healthy individuals. We found that patients had lower diversity of bacteria than healthy individuals and the composition of the gut microbiota differed between patients and healthy people. We could identify some bacteria that have expanded in patients though those are generally observed with low numbers in healthy individuals. We could define certain metabolic signatures that associated with microbial profile. For the first time, we could show a direct link between the arthritis-associated bacteria we identified and enhancement of arthritis using a mice carrying the RA-susceptible HLA gene.

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Creatine Supplement Increased Muscle Mass But Not Strength or Function in RA Patients

Prof. Andrew B Lemmey School of Sport, Health and Exercise Sciences Bangor University Bangor, Gwynedd, Wales, UKMedicalResearch.com Interview with:
Prof. Andrew B Lemmey

School of Sport, Health and Exercise Sciences
Bangor University
Bangor, Gwynedd, Wales, UK

Medical Research: What is the background for this study?

Prof. Lemmey: Substantial loss of lean mass (LM; mostly skeletal muscle) is common in patients with rheumatoid arthritis (RA), as we and others have shown that even amongst patients with well-controlled disease approximately 67% are significantly muscle wasted. This loss of muscle, termed “rheumatoid cachexia”, is a major contributor to the decreased strength and impaired physical function which continues to characterise RA. Unfortunately, current drug treatments for RA, including use of biologics and the ‘treat-to-target (T2T)’ strategy, do not reverse this LM loss, nor fully restore physical function (Lemmey et al., “Tight control of disease activity fails to improve body composition or physical function in rheumatoid arthritis patients”. Submitted to Rheumatology (Oxford), currently under review). Whilst high-intensity exercise (specifically, progressive resistance training (PRT)) has been shown to be highly effective in restoring both  lean mass and function in  rheumatoid arthritis patients (Lemmey et al., Arthritis Care & Research 2009;61(12):1726-34), the lack of uptake and adherence to sufficiently intense training (Lemmey et al., Arthritis Care & Research 2012;64(1):71-5) means this form of therapy is not widely adopted. Anabolic nutritional supplementation offers a potential adjunct treatment intervention for increasing LM, and thereby improving physical function, that could be widely accepted. Indeed, our group (Marcora et al., Clinical Nutrition 2005;24(3):442-54) has previously demonstrated that 12 weeks of daily oral protein supplementation improved lean mass and some measures of strength and function in  rheumatoid arthritis patients.

Creatine (Cr) is a popular dietary supplement generally shown to have greater benefits on both lean mass and physical function than generic protein supplementation. One study (Willer et al., Rheumatology 2000;39(3):293-8) has investigated the efficacy of Cr supplementation in rheumatoid arthritis patients. In this short uncontrolled trial, twelve patients underwent 3 weeks of supplementation, and although strength increased, no changes in function were found, and body composition changes were not investigated.

Using a double-blind, placebo controlled design, the current study aimed to investigate the effects of 12 weeks of oral Cr supplementation on body composition (by DXA; dual energy X-ray absorptiometry), strength (knee-extensor and handgrip) and objectively-assessed physical function (chair and walk tests) in patients with RA. Thirty-five patients (Cr=15, Pl=20) completed the study.  Continue reading

Rheumatoid Arthritis: Remission Sustainable With Tapering of Biologics

Professor Paul Emery Arthritis Research UK Professor of Rheumatology Director - Leeds Musculoskeletal Biomedical Research Unit, LTHT Director – Leeds Institute of Rheumatic and Musculoskeletal Medicine University of LeedsMedicalResearch.com Interview
Professor Paul Emery
Arthritis Research UK Professor of Rheumatology
Director – Leeds Musculoskeletal Biomedical Research Unit, LTHT Director – Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds

Medical Research: What is the background for this study? What are the main findings?

Professor Emery: Joint damage and functional disability are common in people who suffer from rheumatoid arthritis (RA), even in those with early disease. We know that early aggressive treatment with biologics, such as the anti-TNF agent etanercept, results in rapid remission in many patients with moderate-to-severe rheumatoid arthritis, which can help reduce the risk of joint destruction and disability long term. However, we don’t yet know whether remission achieved with biologic therapy can be maintained after doses are reduced or therapy is withdrawn.

The PRIZE trial, a “state-of-the-art” biologic treatment trial conducted in adults with early untreated rheumatoid arthritis, was designed to fill this knowledge gap. The trial included three phases:

  • 1) induction therapy with full-dose combination etanercept-methotrexate therapy;
  • 2) maintenance therapy with a reduced-dose etanercept-methotrexate regimen, methotrexate alone, or no treatment; and
  • 3) complete treatment withdrawal. After clinical remission was induced, remission was shown to be effectively maintained with the reduced-dose combination regimen but not with the biologic-free regimens.Significantly more patients who had received the reduced-dose regimen were in remission after therapy was withdrawn than patients who received no therapy after remission induction. Interestingly, however, after remission was induced with the full-dose combination regimen, no substantial progression of joint damage on x-ray was seen in patients receiving the reduced-dose regimen, methotrexate only, or no treatment.

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Rheumatoid Arthritis: Mycobacterial Infections Relatively Common

MedicalResearch.com Interview with:
Theodore Marras, MD, FRCPC, M.Sc.
Assistant Professor, University of Toronto
Respirologist, Toronto Western Hospital
University Health Network
Toronto, ON, Canada

Medical Research: What are the main findings of the study?

Dr. Marras: Mycobacterial infections (TB and nontuberculous mycobacteria (NTM)) are more common in patients with rheumatoid arthritis (RA). Nontuberculous mycobacteria disease was far more common than TB disease in RA patients in Ontario, Canada. Nontuberculous mycobacteria disease was also associated with increased age, COPD, asthma, and GERD. The presence of nontuberculous mycobacteria disease was associated with increased mortality.
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Obesity Increases Risk of Rheumatoid Arthritis

Dr. Bing Lu, M.D., Dr.P.H. Division of Rheumatology Immunology & Allergy Brigham & Women's Hospital and Harvard Medical School Boston, MA 02115MedicalResearch.com Interview with:
Dr. Bing Lu, M.D., Dr.P.H.
Division of Rheumatology
Immunology & Allergy
Brigham & Women’s Hospital and Harvard Medical School
Boston, MA 02115

Medical Research: What are the main findings of the study?

Dr. Lu: In two large cohorts of women, we observed that being obese increased the risk of rheumatoid arthritis in women by 40–70% depending on age and serologic status. The highest risk for rheumatoid arthritis was among women who were overweight or obese at age 18 years, emphasizing the public health importance of combating the obesity epidemic at all ages. Our study implicates being overweight or obese throughout adult life as a risk factor in the development of seropositive and seronegative RA for women diagnosed with rheumatoid arthritis at age 55 years or younger. The attenuated association between BMI and rheumatoid arthritis diagnosed at older ages may reflect differences in the pathophysiology of RA diagnosed at earlier ages compared with that diagnosed at older ages, or may be a result of the limitations of BMI as a measure of total fat mass as women age.

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Rheumatoid Arthritis: Obesity Impairs Disease Control

Maria E.C. Sandberg, MSc PhD Institutet för Miljömedicin / Institute of Environmental Medicine Karolinska Institutet Stockholm, SwedenMedicalResearch.com Interview with:
Maria E.C. Sandberg, MSc PhD
Institutet för Miljömedicin / Institute of Environmental Medicine
Karolinska Institutet
Stockholm, Sweden

 

MedicalResearch: What are the main findings of the study?

Dr. Sandberg: Overweight at diagnosis significantly decreases the chance of achieving good disease control during the early phase of rheumatoid arthritis (RA).
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