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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 alpha inhibitors

A study has compared efficacy and safety of subcutaneous Sarilumab ( Kevzara ) 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-alpha inhibitors ( TNFi-IR ).

Systematic literature review and network meta-analyses ( NMA ) was 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 ) less than 2.6; serious infections / serious adverse events ( including 52 weeks ).

53 trials were selected for NMA.

csDMARD-IR: Sarilumab 200 mg + csDMARDs and Sarilumab 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 less than 2.6 and to Abatacept, Golimumab, Tocilizumab 4 mg/kg intravenously and Rituximab on DAS28 less than 2.6.
Sarilumab 150 mg was similar to targeted DMARDs but superior to Baricitinib 2 mg and Rituximab on DAS28 less than 2.6 and inferior to Tocilizumab 8 mg on ACR20 and DAS28 less than 2.6.

Serious adverse events, including serious infections, appeared similar for Sarilumab versus comparators.

In conclusion, the 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. ( Xagena )

Choy E et al, RMD Open 2019;5(1):e000798. doi: 10.1136/rmdopen-2018-000798. eCollection 2019