Janssen files Stelara for pediatric Plaque Psoriasis with EMA-Janssen

Janssen-Cilag announced that a Type II Variation has been filed with the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of moderate to severe Plaque Psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. The application is supported by data from the Phase III CADMUS registration study, which evaluated the efficacy and safety, as well as improvements in quality of life, among adolescents (pediatric patients ages 12 to 17) receiving Stelara compared with patients receiving placebo.

The primary endpoint of the study was a PGA score of cleared (0) or minimal (1) at week 12. Secondary endpoints at week 12 included at least a 75 or 90 percent improvement in psoriatic skin lesions, as measured by PASI 75 or PASI 90, and improvement in quality of life, as measured by the Children's Dermatology Life Quality Index (CDLQI) [patient-reported outcome].