FDA Extends Psoriasis Treatment Approval for Adolescents
The FDA has approved an expanded indication for ustekinumab (Stelara; Janssen) for the treatment of adolescent patients 12 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Ustekinumab was approved in September 2009 for the treatment of adults with moderate to severe plaque psoriasis.
The approval was based on the results of a Phase 3 trial that evaluated the efficacy and safety of subcutaneous administration in adolescent participants. The findings showed that roughly two-thirds of study participants were responders at the week 12 primary endpoint after just two doses at weeks 0 and 4, defined by achieving a Physician’s Global Assessment (PGA) score of 0 or 1 (cleared or minimal psoriasis). The safety findings for the adolescent participants were consistent with those seen in studies in adult patients with plaque psoriasis.
The most common side effects reported were upper respiratory infections, headache, and tiredness in psoriasis patients; joint pain and nausea in psoriatic arthritis patients; and upper respiratory infections, redness at the injection site, vaginal yeast infections, itching, urinary tract infections, and vomiting in Crohn’s disease patients. Additionally, treatment can increase serious side effects including, tuberculosis, and infections caused by bacteria, fungi, or viruses.