Amgen announced that its Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared to Humira (adalimumab; AbbVie) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.
Study number 20120263 is a randomized, double-blind, active-controlled study that evaluated the safety and efficacy of ABP 501 compared to adalimumab in adult patients with moderate-to-severe plaque psoriasis. Out of the 350 patients enrolled, 347 patients were randomized to either the ABP 501 group (n=174) or the adalimumab group (n-173). The primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment.
At week 16, patients with a PASI 50 or above response remained on study for up to 52 weeks. Patients continuing on study beyond week 16 were re-randomized in a blinded fashion such that all patients initially randomized to ABP 501 continued to receive ABP 501 and those on adalimumab either continued on adalimumab or switched to ABP 501 in a 1:1 fashion. Patients will continue on treatment until week 48. The final efficacy assessments will be conducted at week 50 and the study will end at week 52.
At week 16, the PASI percent improvement from baseline was within the prespecified equivalence margin for ABP 501 compared to adalimumab. Safety and immunogenicity of ABP 501 were comparable to adalimumab.
ABP 501 is being developed as a biosimilar to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis (PsO), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis.
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