Health Canada approves Stelara for treating psoriasis in adolescents

Health Canada has approved Stelara for treating moderate-to-severe plaque psoriasis in adolescents who are intolerant to or have been inadequately controlled by other systemic therapies or phototherapies, according to a press release from Janssen.

The approval of Stelara (ustekinumab) is based on data from the phase 3 CADMUS study that measured the efficacy and safety of ustekinumab in patients aged 12 to 17 years with moderate-to-severe plaque psoriasis, according to the release. There were 69.4% of patients who received a standard dosing of ustekinumab and achieved a Physician’s Global Assessment of cleared/minimal at week 12, the study’s primary endpoint.

“The long-term efficacy and safety of Stelara is well-documented in adults,” Ian Lendells, MD, FRCPC, clinical associated professor, Department of Pediatrics and Medicine, Memorial University of Newfoundland, and clinical chief of dermatology, Eastern Health in St. John’s Newfoundland and Labrador, stated in the release. “It’s encouraging that adolescents now have this effective treatment option to help manage their psoriasis, and one that has demonstrated good tolerability according to the CADMUS study.”

Ustekinumab blocks the action of interleukin 12 (IL-12) and IL-23, which are believed to play a part in inflammatory conditions including psoriasis and psoriatic arthritis, according to the release.

Ustekinumab, delivered by subcutaneous injection, was approved in Canada for treating adults with psoriasis in 2008, according to the release. In the United States, ustekinumab is approved for treating adults aged 18 years and older with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Upper respiratory tract infections, such as the common cold and headache, are the most commonly reported adverse events, according to the release.

Reference: www.janssen.com