During the study, 311 patients were enrolled and randomized to receive either ABP 798 (n=104), rituximab sourced from the U.S. (n=103) or rituximab sourced from the E.U. (n=104). Treatment was administered as an intravenous infusion at baseline. A second infusion was administered at Week 24.
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The primary objective was pharmacokinetic similarity for ABP 798 compared with rituximab. The pharmacokinetic endpoints were area under the serum concentration–time curve and maximum serum concentration, with both results being within the pre-specified equivalence margin. The pre-specified equivalence in efficacy endpoint was measured by the Disease Activity Score 28-joint count C-reactive protein (DAS28-CRP) change from baseline at Weeks 24 and 48. The study also included a single transition for subjects on rituximab (U.S.) to ABP 798.
ABP 798 met the primary endpoint of pharmacokinetic similarity and established equivalent efficacy. ABP 798 also had a similar safety profile to rituximab, and its immunogenicity and safety were comparable with rituximab.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Amgen Inc. News release: Amgen and Allergan announce positive top-line results from phase 1/phase 3 study of ABP 798, biosimilar candidate to rituximab. 2019 Jan 24.
- Amgen Inc. Study to assess if ABP798 is safe and effective in treating moderate to severe rheumatoid arthritis compared to rituximab. ClincalTrials.gov. 2018 Oct 12.