Stelara Approved in Europe for Plaque Psoriasis

Janssen-Cilag received approval from the European Commission for Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen plus ultraviolet A light).

The approval is based on data from two Phase III, randomized, double-blind, placebo controlled trials involving nearly 2,000 patients. The studies show that treatment with Stelara, the first in a new class of biologics, demonstrated significant improvements in patients’ psoriasis, and quality of life, which were sustained with as few as four injections a year following two starter doses at weeks 0 and 4. Two-thirds or more of patients achieved the primary endpoint of each trial, at least 75% improvement in psoriasis using the Psoriasis Area and Severity Index (PASI 75).