The approval is primarily based on the results of two randomized, controlled, multi-center clinical trials in adult patients: Champion and Reveal. In both trials, the signs and symptoms of psoriasis were measured and evaluated using the Psoriasis Area and Severity Index (PASI) among other measures. Champion was the first head-to-head study comparing a biologic medication to methotrexate, a standard systemic treatment for psoriasis.
In Champion clinical trial, more than 80% of patients taking Humira achieved skin clearance of 75% or better and in Reveal trial, almost three quarters of patients achieved 75% clearance. In both trials, nearly half of the patients taking Humira achieved 90% clearance as early as 16 weeks into treatment.
Humira is said to be the first fully human, self-injectable biologic for the treatment of psoriasis. Psoriasis is the fifth approved indication for Humira in the EU. A regulatory application for Humira to treat psoriasis is also under review with FDA.
Eugene Sun, vice president, global pharmaceutical clinical development, Abbott, said: “This fifth indication for Humira demonstrates its versatility in effectively treating multiple autoimmune disorders from rheumatoid arthritis to Crohn’s disease and now psoriasis.”