FDA approves ustekinumab for pediatric psoriasis

August 7, 2020

The U.S. Food and Drug Administration has approved IL-12/IL-23 inhibitor ustekinumab (Stelara, Janssen Pharmaceutical Companies of Johnson & Johnson) for treatment of moderate-to-severe plaque psoriasis in pediatric patients 6-11 years.

The U.S. Food and Drug Administration (FDA) has approved ustekinumab (Stelara, Janssen Pharmaceutical Companies of Johnson & Johnson) for treatment of moderate-to-severe plaque psoriasis in pediatric patients ages 6-11 years. Ustekinumabis the first and only FDA-approved biologic designed to target interleukin-12 (IL-12) and IL-23, according to the company.1

"We are thrilled that the latest approval for Stelara will bring an alternative class of medication to this patient population and that we are able to deliver on our promise to find meaningful solutions for people afflicted with immune-mediated diseases," says Lloyd Miller, M.D., Ph.D., vice president, immunodermatology disease area leader at Janssen Research & Development, LLC. "While Stelara is currently available for adults and adolescents 12 years and older, children with plaque psoriasis have had more limited treatment options."

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The approval is backed by data from the CADMUS Junior study, a phase 3, multicenter, single-arm, open-label, clinical trial evaluating ustekinumab in 44 pediatric patients with moderate-to-severe plaque psoriasis over the course of 40 weeks.

The primary endpoint in the study was a proportion of patients achieving a Physicians Global Assessment (PGA) skin clearance score of clear (0) or almost clear (1) at week 12. Secondary endpoints included a proportion of patients reaching a Psoriasis Area and Severity Index (PASI) score of 75 or 90 at week 12 from baseline.2

Results of the study demonstrate both primary and secondary endpoints were achieved with 77% of patients achieving a PGA score of 0 or 1 by week 12 following two doses of ustekinumab. Also, at week 12, 84% of patients achieved PASI 75 and 65% with a PASI 90 response. The mean change in the Children’s Dermatology Life Quality Index (CDLQI) was −6·3.2

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Additionally, the safety profile of the study was also consistent with previous studies evaluating ustekinumab in adult patients with 77% of patients experiencing at least one adverse event and 7% with a serious adverse event.2

“Plaque psoriasis presents differently in all patients, making it a challenging disease to both diagnose and treat. Especially in the pediatric population, it is important for patients, parents and physicians to work together to identify an appropriate treatment," says Stacie Bell, Ph.D., chief scientific and medical officer at the National Psoriasis Foundation. "The approval of new treatment options is an exciting step forward to address the unmet needs of children living with psoriasis.”

Currently, ustekinumab is the only approved IL-12/IL-23 inhibitor in the United Stated for both pediatric and adult patients 6 years and older with moderate-to-severe plaque psoriasis, as a monotherapy or in combination with methotrexate in adults with active psoriatic arthritis, adults with moderate-to-severe active Crohn’s disease and moderate-to-severe active ulcerative colitis in adult patients.1

References:

Janssen Pharmaceutical Companies of Johnson & Johnson. U.S. Food and Drug Administration Approves STELARA® (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-stelara-ustekinumab-for-treatment-of-pediatric-patients-with-moderate-to-severe-plaque-psoriasis-301103505.html. Published July 30, 2020. Accessed August 6, 2020.

Philipp S, Menter A, Nikkels A, et al. Ustekinumab for the treatment of moderate‐to‐severe plaque psoriasis in paediatric patients (≥ 6 to < 12 years of age): efficacy, safety, pharmacokinetic and biomarker results from the open‐label CADMUS Jr study. British Journal of Dermatology. 2020. doi:10.1111/bjd.19018