Date: 2015-02-03
Type of information: Results
phase: 3
Announcement: results
Company: Amgen (USA - CA)
Product: ABP 501
Action
mechanism: biosimilar product/monoclonal antibody. ABP 501 is being developed as a biosimilar candidate for adalimumab, an anti-TNF-a monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-a monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: Bulgaria, Canada, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russian Federation, Spain, UK, USA
Trial
details: This randomized, double-blind, active-controlled study (study number 20120262) evaluated safety, efficacy and immunogenicity of ABP 501 compared to adalimumab in adult patients with moderate-to-severe rheumatoid arthritis who have an inadequate response to methotrexate (MTX). The study consisted of a screening period of four weeks and a treatment period of 22 weeks, followed by a safety follow-up period through to week 26. There were 526 patients enrolled. Among them, there were 264 patients randomized to receive ABP 501 40 mg subcutaneous (SC) every two weeks and 262 patients randomized to receive adalimumab 40 mg SC every two weeks. The primary endpoint was assessment of ACR20 at week 24. (NCT01970475)
Latest
news: * On February 3, 2015, Amgen announced a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with Humira® (adalimumab) in patients with moderate-to-severe rheumatoid arthritis met its primary and key secondary endpoints. The primary endpoint compared the ACR20 measurements (20 percent or greater improvement in ACR assessment) at week 24. The ACR20 was within the prespecified margin for ABP 501 compared to adalimumab, showing clinical equivalence. Safety and immunogenicity of ABP 501 were comparable to adalimumab. Key secondary endpoints included ACR50, ACR70 and DAS 28-CRP. ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-a monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn\'s disease and ulcerative colitis. \"The positive results from Amgen\'s biosimilar Phase 3 rheumatoid arthritis study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to adalimumab. Amgen\'s success on both our ABP 501 psoriasis and rheumatoid arthritis studies underscores our expertise in the research and development of high-quality biologic therapies,\" said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen .
