A phase 3 study evaluating the efficacy and safety of Amgen's biosimilar candidate ABP 501 compared with Humira (adalimumab, AbbVie) in treating plaque psoriasis has met its primary endpoint.
A phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with Humira (adalimumab, AbbVie) in treating plaque psoriasis has met its primary endpoint.
According to ABP 501 manufacturer Amgen, 350 adult patients with moderate-to-severe plaque psoriasis were randomly assigned to receive ABP 501 or adalimumab. The study’s primary endpoint was the percent improvement from baseline to week 16 of treatment as measured by the Psoriasis Area and Severity Index (PASI). At week 16, that improvement was within the prespecified equivalence margin for ABP 501 compared with adalimumab. Safety and immunogenicity of ABP 501 were comparable to adalimumab.
Patients with a PASI 50 score or greater will remain in the study for up to 52 weeks. All patients initially randomized to ABP 501 are to continue that treatment, while those on adalimumab will either continue or be switched to ABP 501 on a 1:1 scale. Amgen officials say this is the first of two phase-3 studies that will lead to global regulatory submissions for ABP 501.
“Amgen is pleased with the read-out of our phase 3 study,” Richard Markus, M.D., executive medical director of global development at Amgen, tells Dermatology Times. “The study met its primary endpoint and showed safety and immunogenicity were comparable for ABP 501 and adalimumab. The results are an exciting step toward expanding patient access and speak to our commitment and capability to develop and manufacture complex biologics.”
ABP 501 is being developed as a biosimilar candidate for adalimumab, an antibody approved in many regions for the treatment of several inflammatory diseases.