Date: 2016-09-16
Type of information: Results
phase: 3
Announcement: results
Company: Pfizer (USA - NY)
Product: PF-06438179 (infliximab-Pfizer)
Action
mechanism: monoclonal antibody/biosimilar. Infliximab is a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis. PF-06438179 is being developed as a potential biosimilar to Remicade®. In February 2016, Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 in the 28 countries that form the European Economic Area (EEA). Under the terms of the divestment, Pfizer retains commercialization and manufacturing rights to PF-06438179 in countries outside the EEA.
Disease: moderate to severely active rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Czech Republic, Georgia, Germany, Guatemala, Hungary, Israel, Japan, Jordan, Republic of Korea, Lithuania, Mexico, Morocco, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, South Africa, Tunisia, Ukraine, UK, USA
Trial
details: REFLECTIONS B537-02 is a Phase 3, multi-national, randomized, double blind, two-arm, parallel group study designed to evaluate the safety, efficacy, and immunogenicity of PF-06438179 (infliximab-Pfizer) versus Remicade® in combination with methotrexate when administered intravenously to treat patients with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to methotrexate therapy. This study is also designed to evaluate clinical response, safety and immunogenicity after study drug transitioning from Remicade to PF-06438179 after 30 or 54 weeks of Remicade treatment. The primary endpoint is ACR20 response (?20% improvement by ACR criteria) at Week 14 of study treatment. Evaluation at both earlier time points (Weeks 2, 4, 6, 12) and later time points (Weeks 22 and 30) will be used to support the primary endpoint analysis.(NCT02222493)
Latest
news: * On September 16, 2016, Pfizer announced the confirmatory study (REFLECTIONS B537-02) evaluating the efficacy, safety, and immunogenicity of PF-06438179 (infliximab-Pfizer) compared to Remicade® (infliximab) met its primary endpoint. The trial demonstrated equivalent efficacy of the proposed biosimilar PF-06438179 to the originator product as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.
