Amgen announced results for its Phase 3 study evaluating the safety and efficacy of biosimilar candidate ABP 501 compared to adalimumab (Humira; AbbVie) in patients with moderate-to-severe rheumatoid arthritis who have inadequate response to methotrexate.
This randomized, double-blind, active-controlled study consisted of a screening period of four weeks and a treatment period of 22 weeks, followed by a safety follow-up period through to week 26. Of the 526 patients who were enrolled, 264 patients were randomized to receive ABP 501 40mg subcutaneous (SC) every two weeks and 262 patients were randomized to receive adalimumab 40mg SC every two weeks. The primary endpoint was assessment of ACR20 (≥20% improvement in ACR assessment) at week 24.
The primary endpoint in this study was met. The ACR20 was within the prespecified margin for ABP 501 compared to adalimumab, showing clinical equivalence.
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