The efficacy and safety of ustekinumab for children with moderate to severe plaque psoriasis found support in study data published in the British Journal of Dermatology. Although ustekinumab is an approved psoriasis treatment in adults, this study represents early efforts to characterize its efficacy in pediatric patients.
The CADMUS Jr study was an open-label, single-arm study that enrolled 44 patients aged 6 to 12 years. All patients had moderate to severe plaque psoriasis, defined by an affected body surface area of10% or more, a Psoriasis Area and Severity Index (PASI) ≥12, and a Physician’s Global Assessment score 3 or higher. Patients were treated by single ustekinumab injections at baseline, week 4, and every 12 weeks thereafter. Ustekinumab dosing was as follows: 0.75 mg/kg for children weighing less than 60 kg; 45 mg/kg for children weighing 60 to 100 kg; and 90 mg/kg for children weighing more than 100 kg. By week 12, approximately 64% of patients had achieved 90% or greater improvement in baseline PASI. Patients also reported significant improvement in health-related quality of life per the Children’s Dermatology Life Quality Index. Mean peripheral levels of interleukin (IL)-17A, IL-17F, and IL-22 were also found to decrease between baseline and week 12.
The primary study limitation was its lack of a comparator group; a randomized controlled trial design is needed to better assess efficacy.
Based on the results from the Cadmus Jr study, the European Commission extended ustekinumab approval to children aged 6 to 11 years with moderate to severe plaque psoriasis. The addition of ustekinumab to the list of approved pediatric psoriasis medications “complements the therapeutic armamentarium of biologics available for individuals aged [less than] 18 years,” investigators wrote.
Disclosure: The study author declared affiliations with the pharmaceutical industry.
Please see the original reference for a full list of authors’ disclosures.
Reich K. A new treatment option for paediatric psoriasis. Br J Dermatol. 2020;183(4):606-607.