Phase III REFLECTIONS B538-02 study of PF 06410293 (adalimumab biosimilar) met its primary objective in rheumatoid arthritis- Pfizer

Pfizer has announced that the comparative, confirmatory REFLECTIONS B538-02 study of PF 06410293(adalimumab biosimilar) met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12 for rheumatoid arthritis. This trial is evaluating the efficacy, safety, and immunogenicity of PF 06410293 compared to Humira (adalimumab), each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis. PF-06410293 is being developed as a potential biosimilar to Humira.

REFLECTIONS B538-02 is a multi-national, randomized, double blind, two-arm, parallel group equivalence study [N=597] designed to evaluate the safety, efficacy, and immunogenicity of PF 06410293 (a potential biosimilar to Humira [adalimumab])versus Humira in combination with methotrexate when administered subcutaneously to treat patients with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to methotrexate therapy. The primary endpoint is an equivalent ACR20 response (at least a 20% improvement by ACR criteria) at Week 12 of study treatment.