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
Reads0
Chats0
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
Citations
More filters
Journal ArticleDOI
Diagnosis and Management of Rheumatoid Arthritis: A Review.
Daniel Aletaha,Josef S Smolen +1 more
TL;DR: A treat-to-target strategy aimed at reducing disease activity by at least 50% within 3 months and achieving remission or low disease activity within 6 months, with sequential drug treatment if needed, can prevent RA-related disability.
Journal ArticleDOI
Novel treatment strategies in rheumatoid arthritis
Gerd R Burmester,Janet E. Pope +1 more
TL;DR: New insights into the management of rheumatoid arthritis with targeted therapy approaches using classic and novel medications are described, and the potential effects of precision medicine in this challenging disease are outlined.
Journal ArticleDOI
Targeting Interleukin-6 Signaling in Clinic
TL;DR: The current state of IL-6-targeting approaches in the clinic is reviewed and how to apply the growing understanding of the immunobiology ofIL-6 to clinical decisions is discussed.
Journal ArticleDOI
Translating IL-6 biology into effective treatments.
Ernest Choy,Fabrizio De Benedetti,Tsutomu Takeuchi,Misato Hashizume,Markus R. John,Tadamitsu Kishimoto +5 more
TL;DR: The authors recount the earliest stages of translational research into IL-6 biology and the subsequent development of therapeutic IL- 6 pathway inhibitors for the treatment of autoimmune rheumatic diseases and potentially numerous other indications.
Journal ArticleDOI
The role of IL-6 in host defence against infections: immunobiology and clinical implications
TL;DR: Clinical studies of IL-6 inhibitors, mainly tocilizumab, reveal that their use is associated with an increased rate of both serious and opportunistic infections generally in the range observed with other non-IL-6 directed biologic therapies.
References
More filters
Journal ArticleDOI
Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor
Jean-Michel Dayer,Ernest Choy +1 more
TL;DR: Elevated levels of IL-6 and sIL-6R in the SF of RA patients can increase the risk of joint destruction and, at the joint level, IL- 6/sIL- 6R can stimulate pannus development through increased VEGF expression and increase bone resorption as a result of osteoclastogenesis.
Journal ArticleDOI
Elevated liver enzyme tests among patients with rheumatoid arthritis or psoriatic arthritis treated with methotrexate and/or leflunomide
Jeffrey R. Curtis,Timothy Beukelman,Alina Onofrei,Sarah Cassell,Jeff Greenberg,Arthur Kavanaugh,George W. Reed,Vibeke Strand,Joel M. Kremer +8 more
TL;DR: Abnormal ALT/AST levels developed in 14–35% of patients with rheumatoid arthritis or PsA initiating DMARD therapy, and the combination of MTX and LEF was associated with a greater risk according to MTX dose used as part of the combination.
Journal ArticleDOI
Hepatoprotection via the IL-6/Stat3 pathway
TL;DR: A new study demonstrates that Stat3 provides hepatoprotection against Fas-mediated apoptotic liver damage by two mechanisms: direct inactivation of caspases and reduction of reactive oxygen species.
Journal ArticleDOI
Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative
Laure Gossec,Maxime Dougados,Nathalie Rincheval,Andra Balanescu,Dimitrios T. Boumpas,S Canadelo,Loreto Carmona,J.-P. Daurès,M. de Wit,Ben A. C. Dijkmans,Matthias Englbrecht,Z Gunendi,Turid Heiberg,J. R. Kirwan,Emilio Martin Mola,Marco Matucci-Cerinic,Kati Otsa,G. Schett,Tuulikki Sokka,George A. Wells,G J Aanerud,A Celano,A Dudkin,C Hernandez,K Koutsogianni,F N Akca,A-M Petre,Pamela Richards,Marieke Scholte-Voshaar,G. von Krause,T.K. Kvien +30 more
TL;DR: The preliminary RAID score is a patient-derived weighted score to assess the impact of rheumatoid arthritis that can be used in clinical trials as a new composite index that captures information relevant to patients.
Journal ArticleDOI
Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Results of a Phase III Study
Mark C. Genovese,Roy Fleischmann,Alan Kivitz,Maria Rell-Bakalarska,Renata Martincova,Stefano Fiore,Patricia Rohane,Hubert van Hoogstraten,Anju Garg,Chunpeng Fan,Janet van Adelsberg,Steven P. Weinstein,Neil M.H. Graham,Neil Stahl,George D. Yancopoulos,Tom W J Huizinga,Désirée van der Heijde +16 more
TL;DR: To evaluate the efficacy and safety of sarilumab in combination with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA).
Related Papers (5)
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update
Josef S Smolen,Robert Landewé,Ferdinand C. Breedveld,Maya H Buch,Maya H Buch,Gerd R Burmester,Maxime Dougados,Paul Emery,Paul Emery,Cécile Gaujoux-Viala,Laure Gossec,Jackie L Nam,Jackie L Nam,Sofia Ramiro,Kevin L. Winthrop,Maarten de Wit,Daniel Aletaha,Neil Betteridge,Johannes W. J. Bijlsma,Maarten Boers,Frank Buttgereit,Bernard Combe,Maurizio Cutolo,Nemanja Damjanov,Johanna M. W. Hazes,Marios Kouloumas,Tore K Kvien,Xavier Mariette,Karel Pavelka,Piet L. C. M. van Riel,Andrea Rubbert-Roth,Marieke Scholte-Voshaar,David Scott,T. Sokka-Isler,John B. Wong,Désirée van der Heijde +35 more
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