The comparative, confirmatory REFLECTIONS B538-02 study has met its primary objective by demonstrating equivalent efficacy, as measured by the American College of Rheumatology 20 (ACR20) response rate at week 12, between PF-06410293 (Pfizer) and Humira (adalimumab, AbbVie). PF-06410293, a monoclonal antibody, is being developed as a potential biosimilar to Humira.
The REFLECTIONS B538-02 trial is a multinational, randomized, double-blind, two-arm, parallel-group study designed to evaluate the safety, efficacy, and immunogenicity of PF-06410293 compared with that of Humira in combination with methotrexate when administered subcutaneously to treat patients with moderately to severely active rheumatoid arthritis (RA) who have shown an inadequate response to methotrexate therapy. A total of 597 subjects were enrolled in the study.
Humira is approved in the United States for multiple indications, including RA, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
PF-06410293 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not yet claimed by the compound’s developer.
Source: Pfizer; January 5, 2017.