Janssen launches Stelara in the UK for treating psoriasis in adolescents

Janssen-Cilag Ltd. announced the availability of Stelara in the United Kingdom for the treatment of moderate-to-severe plaque psoriasis in adolescents age 12 years and older who have not responded to or are intolerant to other systemic therapies or phototherapies.

The European Commission approved this indication for Stelara (ustekinumab) in June, and the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion in May, according to a press release.

The European Commission approval was based on phase 3 study results of patients aged 12-17 years with moderate-to-severe plaque psoriasis. The patients were randomly assigned to subcutaneous placebo, ustekinumab standard dosing or ustekinumab half-standard dosing at weeks 0 and 4 followed by dosing every 12 weeks. Body weight determined ustekinumab dosing tiers. The placebo cohort began receiving ustekinumab standard dose or half-standard dose at weeks 12 and 16, according to the release. Maintenance dosing continued through week 40.

“Ustekinumab is an innovative biologic which, we know from recent trials, can positively impact the lives of younger people with psoriasis,” Anthony Bewley, BA(Hons), MBChB, FRCP, consultant dermatologist at Whipps Cross University Hosptial and Royal London Hospital, and study investigator, said in the release. “Ustekinumab has been used in adults for a number of years now and we know it has been beneficial in the management of adult psoriasis, so to have the full data for the use of this medication in younger people is a great step forwards.”

In the phase 3 study, patients treated with ustekinumab displayed “significantly greater improvements in their psoriasis and health-related quality of life [at week 12] compared with placebo,” according to the release.

Efficacy in the standard dose group was generally higher and better sustained compared with the half-standard dose group, according to the release.

All patients received at least one injection of ustekinumab through week 40, with 81.8% reporting an adverse event through week 60, with 5.5% of patients reporting a serious adverse event, according to the release. There were no reports of malignancies, opportunistic infections or anaphylactic reactions.

Reference: www.janssen.co.uk