Evaluation of the efficacy and safety of sarilumab combination therapy in patients with rheumatoid arthritis with inadequate response to conventional disease-modifying antirheumatic drugs or tumour necrosis factor α inhibitors: systematic literature review and network meta-analyses

被引:13
作者
Choy, Ernest [1 ]
Freemantle, Nick [2 ]
Proudfoot, Clare [3 ]
Chen, Chieh-I [4 ]
Pollissard, Laurence [5 ]
Kuznik, Andreas [4 ]
Van Hoogstraten, Hubert [6 ]
Mangan, Erin [7 ]
Carita, Paulo [5 ]
Thi-Minh-Thao Huynh [8 ]
机构
[1] Cardiff Univ, Div Infect & Immun, Cardiff, S Glam, Wales
[2] UCL, Inst Clin Trials & Methodol, London, England
[3] Sanofi, Hlth Econ & Outcomes Res, Guildford, Surrey, England
[4] Regeneron Pharmaceut Inc, Hlth Econ & Outcomes Res, New York, NY USA
[5] Sanofi France, Global Hlth Econ & Value Assessment, Chilly Mazarin, France
[6] Sanofi, I&I, Global Med Affairs, Bridgewater, NJ USA
[7] Regeneron Pharmaceut Inc, Med Affairs, New York, NY USA
[8] Sanofi France, Real World Evidence & Clin Outcome Generat, Chilly Mazarin, France
来源
RMD OPEN | 2019年 / 5卷 / 01期
关键词
ISPOR TASK-FORCE; DOUBLE-BLIND; TOCILIZUMAB MONOTHERAPY; ADALIMUMAB MONOTHERAPY; SUBCUTANEOUS ABATACEPT; METHOTREXATE THERAPY; PLUS METHOTREXATE; PLACEBO; ETANERCEPT; GOLIMUMAB;
D O I
10.1136/rmdopen-2018-000798
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective To compare efficacy and safety of subcutaneous sarilumab 200 mg and 150 mg every 2 weeks plus conventional synthetic disease-modifying antirheumatic drugs (+ csDMARDs) versus other targeted DMARDs+ csDMARDs and placebo+ csDMARDs, in inadequate responders to csDMARDs (csDMARD-IR) or tumour necrosis factor a inhibitors (TNFi-IR). Methods Systematic literature review and network metaanalyses (NMA) conducted on 24 week efficacy and safety outcomes: Health Assessment Questionnaire Disability Index, modified total sharp score (mTSS, including 52 weeks), American College of Rheumatology (ACR) 20/50/70, European League Against Rheumatism Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28)< 2.6; serious infections/serious adverse events (including 52 weeks). Results 53 trials were selected for NMA. csDMARD-IR: Sarilumab 200 mg+ csDMARDs and 150 mg+ csDMARDs were superior versus placebo+ csDMARDs on all outcomes. Against most targeted DMARDs, sarilumab 200 mg showed no statistically significant differences, except superiority to baricitinib 2 mg, tofacitinib and certolizumab on 24 week mTSS. Sarilumab 150 mg was similar to all targeted DMARDs. TNFi-IR: Sarilumab 200 mg was similar to abatacept, golimumab, tocilizumab 4 mg and 8 mg/kg intravenously and rituximab on ACR20/50/70, superior to baricitinib 2 mg on ACR50 and DAS28< 2.6 and to abatacept, golimumab, tocilizumab 4 mg/kg intravenously and rituximab on DAS28< 2.6. Sarilumab 150 mg was similar to targeted DMARDs but superior to baricitinib 2 mg and rituximab on DAS28< 2.6 and inferior to tocilizumab 8 mg on ACR20 and DAS28< 2.6. Serious adverse events, including serious infections, appeared similar for sarilumab versus comparators. Conclusions Results suggest that in csDMARD-IR and TNFi-IR (a smaller network), sarilumab+csDMARD had superior efficacy and similar safety versus placebo+csDMARDs and at least similar efficacy and safety versus other targeted DMARDs+csDMARDs.
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页数:13
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