Date: 2014-10-08
Type of information: Results
phase: 3
Announcement: results
Company: Amgen (USA - CA)
Product: ABP 501 (biosimilar version of Humira® (adalimumab))
Action mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor. ABP 501 is being developed as a biosimilar candidate for adalimumab, an anti-TNF-? 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-? monoclonal antibody which 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: moderate-to-severe plaque psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country:
Trial details: This randomized, double-blind, active-controlled study (study number 20120263) evaluated safety and efficacy of ABP 501 compared to adalimumab in adult patients with moderate-to-severe plaque PsO. There were 350 patients enrolled and initially randomized. Among them, there were 174 patients in the ABP 501 group and 173 patients in the adalimumab group treated. One patient in the ABP 501 group and two patients in the adalimumab group were randomized but did not receive any investigational product. The primary endpoint, PASI percent improvement, was evaluated at week 16. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale) of the lesions, weighted by the area of involvement. All assessments for a given patient were made by the same observer whenever possible. At week 16, patients with a PASI 50 or above response will remain 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, when the patients will receive the last dose of investigational product. The final efficacy assessments will be conducted at week 50 and the study will end at week 52.
Latest
news:
