Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis

ConclusionsClinical equivalence in terms of efficacy, safety, and immunogenicity was established between ABP 798 and rituximab RP in this comparative clinical trial in patients with moderate-to-severe RA.Key Points• ABP 798 provided similar efficacy as rituximab reference product (RP) in patients with moderate-severe rheumatoid arthritis.• The safety and immunogenicity profiles for ABP 798 were similar to those for the rituximab RP.• The single transition from rituximab RP to ABP 798 did not show differences in efficacy, safety, or immunogenicity.
Source: Clinical Rheumatology - Category: Rheumatology Source Type: research