Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial
Gerd R Burmester,Yong Lin,Rahul Patel,Janet van Adelsberg,E.K. Mangan,Neil M.H. Graham,Hubert van Hoogstraten,Deborah Bauer,Juan Ignacio Vargas,Eun Bong Lee +9 more
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TLDR
Sarilumabmonotherapy demonstrated superiority to adalimumab monotherapy by improving the signs and symptoms and physical functions in patients with RA who were unable to continue MTX treatment.Abstract:
Objectives To compare efficacy and safety of sarilumab monotherapy with adalimumab monotherapy in patients with active rheumatoid arthritis (RA) who should not continue treatment with methotrexate (MTX) due to intolerance or inadequate response. Methods MONARCH was a randomised, active-controlled, double-blind, double-dummy, phase III superiority trial. Patients received sarilumab (200 mg every 2 weeks (q2w)) or adalimumab (40 mg q2w) monotherapy for 24 weeks. The primary end point was change from baseline in 28-joint disease activity score using erythrocyte sedimentation rate (DAS28-ESR) at week 24. Results Sarilumab was superior to adalimumab in the primary end point of change from baseline in DAS28-ESR (−3.28 vs −2.20; p Conclusions Sarilumab monotherapy demonstrated superiority to adalimumab monotherapy by improving the signs and symptoms and physical functions in patients with RA who were unable to continue MTX treatment. The safety profiles of both therapies were consistent with anticipated class effects. Trial registration number NCT02332590.read more
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Blocking only the bad side of IL-6 in inflammation and cancer.
TL;DR: In this article, a fusion protein of soluble gp130 with the constant portion of human IgG1 (sgp130Fc) turned out to be a potent and specific inhibitor of IL-6 trans-signaling.
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High levels of interleukin-6 in patients with rheumatoid arthritis are associated with greater improvements in health-related quality of life for sarilumab compared with adalimumab.
TL;DR: This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL- 6 receptor α (anti-IL-6Rα) versus adalimumab, both approved for treatment of active RA.
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Sarilumab monotherapy or in combination with non-methotrexate disease-modifying antirheumatic drugs in active rheumatoid arthritis: A Japan phase 3 trial (HARUKA).
Hideto Kameda,Kazuteru Wada,Yoshinori Takahashi,Owen Hagino,Hubert van Hoogstraten,Neil M.H. Graham,Yoshiya Tanaka +6 more
TL;DR: Sarilumab as mono- or combination therapy improved clinical signs/symptoms and physical function in Japanese RA patients and was consistent with known class effects of interleukin-6 signaling blockade therapeutics.
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Biological Therapies for Rheumatoid Arthritis: An Overview for the Clinician
TL;DR: There are five classes of biological disease modifying anti-rheumatic drugs (bDMARDs) currently available, each with a different molecular target and subtle differences in their efficacy and safety profile as mentioned in this paper.
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The Giants (biologicals) against the Pigmies (small molecules), pros and cons of two different approaches to the disease modifying treatment in rheumatoid arthritis.
TL;DR: In this review the PROS and CONS of these two drug classes will be discussed, trying to provide the evidence currently available to make the right choice based on the analysis of the efficacy and safety profile of the different drugs on the market and close to marketing.
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TL;DR: This new classification system redefines the current paradigm of RA by focusing on features at earlier stages of disease that are associated with persistent and/or erosive disease, rather than defining the disease by its late-stage features.
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TL;DR: In patients with persistently active rheumatoid arthritis despite methotrexate therapy, repeated doses of infliximab in combination with methotRexate provided clinical benefit and halted the progression of joint damage.
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2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis
Jasvinder A. Singh,Kenneth G. Saag,S. Louis Bridges,Elie A. Akl,Raveendhara R. Bannuru,Matthew C. Sullivan,Elizaveta E. Vaysbrot,Christine McNaughton,Mikala C. Osani,Robert H. Shmerling,Jeffrey R. Curtis,Daniel E. Furst,Deborah Parks,Arthur Kavanaugh,James R. O'Dell,Charles H. King,Amye Leong,Eric L. Matteson,John T. Schousboe,Barbara E. Drevlow,Seth Ginsberg,James Grober,E. William St. Clair,Elizabeth A. Tindall,Amy S. Miller,Timothy E. McAlindon +25 more
TL;DR: To develop a new evidence‐based, pharmacologic treatment guideline for rheumatoid arthritis (RA), a large number of patients with RA are referred to a single clinic for treatment with these medications.
Journal ArticleDOI
A Comparison of Etanercept and Methotrexate in Patients with Early Rheumatoid Arthritis
Joan M. Bathon,Richard J. Martin,Roy Fleischmann,John Tesser,Michael Schiff,Edward C. Keystone,Mark C. Genovese,Mary Chester M. Wasko,Larry W. Moreland,Arthur L. Weaver,Joseph A. Markenson,Barbara K. Finck +11 more
TL;DR: Subcutaneous [corrected] etanercept acted more rapidly to decrease symptoms and slow joint damage in patients with early active rheumatoid arthritis.
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