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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


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<0.0001). Sarilumab-treated patients achieved significantly higher American College of Rheumatology 20/50/70 response rates (sarilumab: 71.7%/45.7%/23.4%; adalimumab: 58.4%/29.7%/11.9%; all p≤0.0074) and had significantly greater improvement in Health Assessment Questionnaire-Disability Index (p=0.0037). Importantly, at week 24, more patients receiving sarilumab compared with adalimumab achieved Clinical Disease Activity Index remission (7.1% vs 2.7%; nominal p=0.0468) and low disease activity (41.8% vs 24.9%; nominal p=0.0005, supplemental analysis). Adverse events occurred in 63.6% (adalimumab) and 64.1% (sarilumab) of patients, the most common being neutropenia and injection site reactions (sarilumab) and headache and worsening RA (adalimumab). Incidences of infections (sarilumab: 28.8%; adalimumab: 27.7%) and serious infections (1.1%, both groups) were similar, despite neutropenia differences.

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.

  • Rheumatoid Arthritis
  • Treatment
  • DMARDs (biologic)

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  • Handling editor Tore K Kvien

  • Contributors GRB, YL, RP and JvA were involved in the conception and design of the study. GRB, YL, RP, DB, JIV and EBL were involved in data acquisition. GRB, YL, RP, JvA, EKM, NMHG, HvH, DB, JIV and EBL were involved in data analysis and interpretation. GRB, YL and JvA were involved in manuscript drafting. GRB, YL, RP, JvA, EKM, NMHG, HvH, DB, JIV and EBL were involved in critically revising the manuscript and approved the final version.

  • Funding This study was sponsored by Sanofi Genzyme and Regeneron Pharmaceuticals.

  • Competing interests GRB has received research grants or consulting fees from AbbVie, Bristol-Myers Squibb, MedImmune, Merck, Pfizer, Roche and UCB and has participated in speakers' bureaus for AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche and UCB. EBL has acted as a consultant to Pfizer. JIV has received speaker fees from Roche, Bristol-Myers Squibb and Pfizer and has participated in speakers' bureaus for Bristol-Myers Squibb. YL, RP, HvH and DB are employees of Sanofi Genzyme and may hold stock and/or stock options in the company. JvA, EKM and NMHG are employees of Regeneron Pharmaceuticals and may hold stock and/or stock options in the company.

  • Ethics approval Individual Study Sites’ Institutional Review Boards.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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