Roy M Fleischmann, Désirée van der Heijde, Vibeke Strand, Tatsuya Atsumi, Iain B McInnes, Tsutomu Takeuchi, Peter C Taylor, Marguerite Bracher, David Brooks, John Davies, Christopher Goode, Anubha Gupta, Sumanta Mukherjee, Ciara O'Shea, Didier Saurigny, Lorrie A Schifano, Celia Shelton, Julia E Smith, Millie Wang, Reena Wang, Sarah Watts, Michael E Weinblatt
OBJECTIVES: To investigate the efficacy and safety of otilimab, an antigranulocyte-macrophage colony-stimulating factor antibody, in patients with active rheumatoid arthritis. METHODS: Two phase 3, double-blind randomised controlled trials including patients with inadequate responses to methotrexate (contRAst 1) or conventional synthetic/biologic disease-modifying antirheumatic drugs (cs/bDMARDs; contRAst 2). Patients received background csDMARDs. Through a testing hierarchy, subcutaneous otilimab (90/150 mg once weekly) was compared with placebo for week 12 endpoints (after which, patients receiving placebo switched to active interventions) or oral tofacitinib (5 mg two times per day) for week 24 endpoints...
December 2023: Annals of the Rheumatic Diseases