Author Interviews, Pain Research, Rheumatology / 12.09.2019

MedicalResearch.com Interview with: W. Benjamin Nowell, Ph.D. Director of Patient-Centered Research CreakyJoints, Principal Investigator of ArthritisPower MedicalResearch.com: What is the background for this study? Response: Over the past fifteen years, the treatment options for people diagnosed and living with rheumatoid arthritis (RA) have grown. There are now many medications (particularly biologic disease-modifying antirheumatic drugs, or bDMARDs) proven to improve disease symptoms and immune system over activity, thereby reducing inflammation and joint damage. The American College of Rheumatology recommends a treat-to-target approach, which has the patient and rheumatologist setting goals for treatment effectiveness and making adjustments over time to meet those goals. This study aimed to determine if rheumatoid arthritis patients are satisfied with their treatment. The goal of this study was to identify the following: patients’ satisfaction with current RA treatment, the current unmet needs perceived by patients with rheumatoid arthritis in the United States, the symptoms of rheumatoid arthritis that are most bothersome to patients, and the impact of symptoms on function and quality of life that may lead patients to need alternative treatments.  (more…)
Author Interviews, Occupational Health, Rheumatology / 01.11.2018

MedicalResearch.com Interview with: Dr. W. Benjamin Nowell, Ph.D. Director of Patient-Centered Research CreakyJoints, study co-author Co-principal investigator of ArthritisPower MedicalResearch.com: What is the background for this study? What are the main findings? Response: Rheumatoid Arthritis (RA) can diminish patients’ work productivity and increase the risk of long-term disability, economic insecurity and worsening health, but limited research informs these issues. The purpose of our study was to examine associations between patients’ RA disease activity and their productivity and workplace support, using real-world data from the ArthritisPower research registry. Our study looked at a sample of participants with RA who had a history of or current treatment with non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARD) (n=296). Among the study sample, 74 percent had high disease activity (HDA) as determined by RAPID3 (>12), a common measure of disease activity in RA.
  • High disease activity was associated with lower education (p<0.001) and higher likelihood of disability (9%, p<0.001) compared to those without high disease activity.
    • Patients with HDA missed more days of work than non-HDA patients (mean: 6.1 vs 3.8 days, respectively; p=0.03), but non-HDA participants reported more days off due to medical appointments (2.6 vs 1.2 days, respectively) while HDA patients missed more days due to RA treatment side effects (mean: 0.5 vs 0.1 days, respectively).
  • Based on scores from the Work Productivity and Activity Impairment (WPAI) questionnaire, RA seems to affect work productivity to a greater extent in participants with HDA than without (WPAI scores 5.3 and 3.3, respectively; p<0.001). Participants who were not currently employed reported having more physically demanding tasks (e.g. heavy load lifting) and less workplace flexibility (e.g. working from home) in their most recent paid position than currently employed participants.
  • However, in a multivariate regression analysis, we found that participants who could request changes in work start and stop times on a daily basis were 2.9 (95% CI: 1.53, 5.46) times more likely to be unemployed (adjusting for age, disease activity, and satisfaction with social participation) than those unable to make this request (p<0.0001).
About ArthritisPower: Created by CreakyJoints and supported by a multiyear, multimillion dollar investment by the Patient-Centered Outcomes Research Institute (PCORI), ArthritisPower is the first-ever patient-centered research registry for joint, bone, and inflammatory skin conditions. The free ArthritisPower mobile and desktop application allows patients to track and share their symptoms and treatments while also participating in voluntary research studies in a secure and accessible manner. ArthritisPower Patient Governors serve as gatekeepers for researchers who seek access to registry data or solicit the community to participate in unique, voluntary studies. To learn more and join ArthritisPower, visit www.ArthritisPower.org.  (more…)
Author Interviews, Bristol Myers Squibb, Rheumatology, Smoking / 24.10.2018

MedicalResearch.com Interview with: Pr Gilles Boire, M.D., M. ScService de rhumatologie Département de médecine Faculté de médecine et des sciences de la santé Université de Sherbrooke MedicalResearch.com: What is the background for this study? Response: Rheumatoid arthritis (RA) patients are heterogeneous at initial presentation, in response to treatments and according to their outcomes. No clinical features and very few biomarkers, except autoantibodies such as anti-Cyclic Citrullinated Peptides/Proteins (CCP), identify patients with divergent prognostic trajectories. To help improve early prognostic classification, we initiated 20 years ago the single center longitudinal observational Early Undifferentiated PolyArthritis (EUPA) study of consecutive patients presenting with recent-onset inflammatory polyarthritis, 90% of which fulfill classification criteria for RA at baseline. Our registry includes 739 very early RA patients (median symptom duration 3.6 months), rapidly treated to joint remission (i.e. 0/66 swollen joint) and followed over 5 years. Each patient visit is linked to biosamples and to sequential radiographs scored according to the modified Sharp/van der Heijde method. As we had the clinical impression that clinical features of recruited patients were evolving, we compared patients from 3 periods (1998-2004; 2005-2010; 2011-2017).  (more…)
Author Interviews, Lancet, Rheumatology, UT Southwestern / 20.06.2017

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 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. (more…)
Author Interviews, Brigham & Women's - Harvard, Dental Research, Infections, Rheumatology, Science / 17.12.2016

MedicalResearch.com Interview with: Maximilian F. Konig, MD Division of Rheumatology, Johns Hopkins University School of Medicine Current affiliation: Department of Medicine Massachusetts General Hospital Harvard Medical School MedicalResearch.com: What is the background for this study? Response:The idea that rheumatoid arthritis (RA), an autoimmune disease that leads to chronic joint inflammation and destruction, may be initiated by a bacterial infection is not novel, but has been posited for more than a century. Based on the clinical observation that patients with RA frequently have severe periodontal disease (gum disease), gum inflammation has long been thought to contribute to disease development in RA. However, limited understanding of the mechanisms that fuel and sustain the autoimmune attack in RA made it difficult to pinpoint a specific bacterial trigger. In recent years, our understanding of the abnormal immune response that attacks the joints in patients with RA has grown exponentially, and we now know that disease-specific autoantibodies (ACPAs) target modified self-proteins (this modification is known as citrullination). It is this abnormal immune response against citrullinated proteins that appears to drive the joint (and sometimes lung) inflammation seen in rheumatoid arthritis. Recent studies from our laboratory at The Johns Hopkins University (led by principle investigator Felipe Andrade, MD, PhD) suggested that an immune cell called the neutrophil, which normally protects us from infection at sites like the oral cavity or anywhere else in the body, also appears to be the source of the proteins attacked in RA. We were therefore interested to understand what drives the association of gum disease, an inflammation commonly triggered by bacteria, with RA. (more…)
Author Interviews, JAMA, Pharmacology, Rheumatology / 23.09.2016

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. (more…)
Author Interviews, NEJM, Rheumatology / 21.06.2014

Bethanie Wilkinson, Ph.D. Pfizer  445 Eastern Point Rd. Groton, CT 06340MedicalResearch.com Interview with Bethanie Wilkinson, Ph.D. Pfizer 445 Eastern Point Rd. Groton, CT 06340   MedicalResearch: What are the main findings of the study? Dr. Wilkinson: ORAL Start showed that XELJANZ (tofacitinib citrate) 5 and 10 mg twice daily (BID), taken by itself without methotrexate (MX), inhibited the progression of structural damage and reduced the signs and symptoms of rheumatoid arthritis (RA), and was statistically significantly superior to methotrexate on these measures at Month 6 (primary endpoint) and at all measured time points up to 24 months in patients with rheumatoid arthritis who had not previously received methotrexate or therapeutic doses of methotrexate.  XELJANZ is not indicated in patients who had not previously received methotrexate.
  •  Both doses of XELJANZ met the study’s co-primary efficacy endpoints of mean change from baseline in van der Heijde modified Total Sharp Score (mtss) [0.18 and 0.04 (both P<0.001) for tofacitinib 5 and 10 mg BID, respectively, versus 0.84 for MTX], and ACR70 response rates [25.5% and 37.7% for tofacitinib 5 and 10 mg BID (both P<0.001) versus 12.0% for MTX], at Month 6.
  • These results were sustained at all measured time points up to 24 months.
(more…)
Author Interviews, BMJ, Karolinski Institute, Rheumatology / 06.06.2014

MedicalResearch.com Interview with: Karen Hambardzumyan Research Assistant Karolinska Institute Department of Medicine, (ClinTRID) D1:00, Karolinska University Hospital Solna Stockholm MedicalResearch: What are the main findings of the study? Answer: One of the difficulties with rheumatoid arthritis (RA) treatment is unpredictable treatment outcome at the individual patient level. The course might be mild or severe independently of the therapy. To identify subgroups of patients who will benefit from specific therapy strategies is one of the goals for today’s rheumatologists. We have investigated a Multi-Biomarker Disease Activity (MBDA) score in patients from the Swedish Farmacotherapy (SWEFOT) clinical trial, where early rheumatoid arthritis patients were included/studied. The main finding was the usefulness of the MBDA score for prediction of those patients who will not get joint damage detected by X-rays (radiographic progression) during one year follow-up. This MBDA score, developed by Crescendo Bioscience (South San-Francisco, CA, USA) is based on serum levels of 12 different protein biomarkers and can categorize patients into 3 groups: patients with low, moderate and high disease activity. Ninety-seven percent of patients who had low or moderate MBDA score before treatment onset, did not experience radiographic progression during one year follow-up. This finding could contribute to a personalised approach to the RA patients for the optimal therapy choice. (more…)