Efficacy and Safety of Subcutaneous and Intravenous Loading Dose Regimens of Secukinumab in Patients with Active Rheumatoid Arthritis: Results from a Randomized Phase II Study.

摘要: Objective. To evaluate the efficacy and safety of secukinumab, a fully human antiinterleukin-17A monoclonal antibody, administered with an intravenous (IV) or subcutaneous (SC) loading regimen versus placebo, in patients active rheumatoid arthritis (RA). Methods. In this phase II, double-blind, double-dummy, 52-week study ([ClinicalTrials.gov][1] [NCT01359943][2]), 221 inadequate response to methotrexate were randomized (2:2:1) IV 10 mg/kg at baseline, Weeks 2 4, then SC 150 mg every 4 weeks (n = 88); secukinumab once weekly for 5 weeks, 89); matching placebo (followed by starting Week 16; n 44). The primary endpoint was superior pooled using American College Rheumatology 20% (ACR20) 12. Results. not met: ACR20 12 49.2% 40.9% (p 0.3559). These variables improved significantly (all p < 0.05): 28-joint Disease Activity Score (DAS28), patient’s physician’s global assessment disease activity, RA pain, high-sensitivity C-reactive protein levels. Results continuous outcomes similar between regimens. most frequent adverse events infections, rates across placebo. Conclusion. Although met, demonstrated reducing activity over as measured DAS28 other secondary endpoints. [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01359943&atom=%2Fjrheum%2F43%2F3%2F495.atom