Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: Results of a phase III study.

Estándar

Arthritis Rheumatol. 2015 Mar 2. doi: 10.1002/art.39093. [Epub ahead of print]

Genovese et al

Abstract

Objectives. To evaluate the efficacy and safety of sarilumab in combination with methotrexate (MTX) for treatment of rheumatoid arthritis (RA).

Methods. Adults with moderate-to-severe RA and inadequate response to MTX were randomized (1:1:1) to sarilumab 150mg, 200 mg, or placebo every 2 weeks (q2w) with MTX for 52 weeks.

Results. Baseline characteristics were similar among groups. For all three co-primary endpoints, sarilumab 150mg and 200mg groups demonstrated statistically significant improvements vs placebo: ACR20 response at Week 24 (58.0%, 66.4% vs 33.4%; p<0.0001), HAQ-DI at Week 16 (−0.53, −0.55, vs −0.29; p<0.0001) and mTSS at Week 52 (0.90, 0.25 vs 2.78; p<0.0001).

The most common treatment-emergent adverse event was infection; serious infections incidence was 2.6%, 4.0%, and 2.3% (sarilumab 150mg, 200 mg, and placebo, respectively). Elevations in alanine aminotransferase >3-fold the upper limit of normal in 9.5%, 8.0%, and 2.1% of patients led to discontinuation of 24 patients. Elevated total cholesterol levels were observed in 36.8%, 43.0% and 18.3% of sarilumab 150mg, 200 mg and placebo patients, respectively. Neutrophil counts 500–

Conclusions: In RA patients treated with sarilumab (150mg and 200mg q2w) in combination with MTX, both doses provided sustained clinical efficacy, significantly improving symptomatic, functional, and radiographic outcomes. Sarilumab was generally well tolerated. The adverse events observed in this study were consistent with IL-6 signaling blockade.

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