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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

Burmester, Gerd R, Lin, Yong, Patel, Rahul, van Adelsberg, Janet, Mangan, Erin K, Graham, Neil M H, van Hoogstraten, Hubert, Bauer, Deborah, Ignacio Vargas, Juan, Lee, Eun Bong·2017·Annals of the Rheumatic Diseases
DOI 10.1136/annrheumdis-2016-210310PMC PMC5530335
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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<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.

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Figure 1 Flow diagram showing patient disposition. *Primary reasons for patient ineligibility were meeting the exclusion criteria related to tuberculosis (12.0%) or failure to meet the inclusion criterion for severity of disease (8.1%). †One patient was randomised but not treated in the adalimumab group. ‡The actual number of patients who received a dose-escalation kit on the basis of meeting protocol criteria were 6 (3.2%) in the adalimumab group and 5 (2.7%) in the sarilumab group. q2w, every 2 weeks.
Figure 1 Flow diagram showing patient disposition. *Primary reasons for patient ineligibility were meeting the exclusion criteria related to tuberculosis (12.0%) or failure to meet the inclusion criterion for severity of disease (8.1%). †One patient was randomised but not treated in the adalimumab group. ‡The actual number of patients who received a dose-escalation kit on the basis of meeting protocol criteria were 6 (3.2%) in the adalimumab group and 5 (2.7%) in the sarilumab group. q2w, every 2 weeks.CC BY-NC · PubMed Central
Figure 2 Change from baseline in (A) DAS28-ESR and (B) DAS28-CRP in patients receiving adalimumab 40 mg q2w or sarilumab 200 mg q2w. **p<0.001 versus adalimumab (DAS28-CRP are nominal p values). CRP, C reactive protein; DAS28-ESR, 28-joint disease activity score using erythrocyte sedimentation rate; LS, least squares; q2w, every 2 weeks.
Figure 2 Change from baseline in (A) DAS28-ESR and (B) DAS28-CRP in patients receiving adalimumab 40 mg q2w or sarilumab 200 mg q2w. **p<0.001 versus adalimumab (DAS28-CRP are nominal p values). CRP, C reactive protein; DAS28-ESR, 28-joint disease activity score using erythrocyte sedimentation rate; LS, least squares; q2w, every 2 weeks.CC BY-NC · PubMed Central
Figure 3 Incidence of (A) DAS28-ESR remission or LDA, (B) ACR20, ACR50 and ACR70 response from weeks 4 to 24, (C) CDAI remission or LDA and (D) HAQ-DI responders achieving ≥0.22 or ≥0.3 units of improvement in patients receiving adalimumab 40 mg q2w or sarilumab 200 mg q2w. *p<0.05 versus adalimumab; **p<0.01 versus adalimumab (CDAI and HAQ-DI responders at week 24 are nominal p values); †p<0.0001 versus adalimumab. ACR, American College of Rheumatology; CDAI, Clinical Disease Activity Index; DAS28-ESR, 28-joint disease activity score using erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; LDA, low disease activity; q2w, every 2 weeks.
Figure 3 Incidence of (A) DAS28-ESR remission or LDA, (B) ACR20, ACR50 and ACR70 response from weeks 4 to 24, (C) CDAI remission or LDA and (D) HAQ-DI responders achieving ≥0.22 or ≥0.3 units of improvement in patients receiving adalimumab 40 mg q2w or sarilumab 200 mg q2w. *p<0.05 versus adalimumab; **p<0.01 versus adalimumab (CDAI and HAQ-DI responders at week 24 are nominal p values); †p<0.0001 versus adalimumab. ACR, American College of Rheumatology; CDAI, Clinical Disease Activity Index; DAS28-ESR, 28-joint disease activity score using erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; LDA, low disease activity; q2w, every 2 weeks.CC BY-NC · PubMed Central

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Research works printed but not linked: 36

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Metadata

Authors
Burmester, G. R., Lin, Y., Patel, R., van Adelsberg, J., Mangan, E. K., Graham, N. M. H., van Hoogstraten, H., Bauer, D., Ignacio Vargas, J., & Lee, E. B.
Venue
Annals of the Rheumatic Diseases
Publisher
Elsevier BV
Published
2017-05
Volume
76
Issue
5
Pages
840-847
ISSN
0003-4967
DOI
10.1136/annrheumdis-2016-210310
PMC
PMC5530335
Cited by
272
References
0
Language
en
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CoChat. (2026). Citation check: 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. https://app.cochat.ai/papers/10.1136/annrheumdis-2016-210310
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Burmester, G. R., Lin, Y., Patel, R., van Adelsberg, J., Mangan, E. K., Graham, N. M. H., van Hoogstraten, H., Bauer, D., Ignacio Vargas, J., & Lee, E. B. (2017). 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. Annals of the Rheumatic Diseases. https://doi.org/10.1136/annrheumdis-2016-210310

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