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

Abstract

Background Limited options are available for treatment of pediatric psoriasis. Objectives To evaluate the efficacy and safety of ustekinumab in pediatric psoriasis patients (≥6 to <12 years of age). Methods CADMUS Junior (Jr), a phase 3, open‐label, single‐arm, multicenter study, evaluated ustekinumab in pediatric patients with moderate‐to‐severe plaque psoriasis. Patients received weight‐based dosing of ustekinumab (100kg: 90mg) administered by subcutaneous injection at weeks 0/4, then every‐12‐weeks through week 40. Study endpoints (all at week 12) included the proportions of patients achieving a Physician’s Global Assessment score of cleared/minimal (PGA 0/1) and ≥75%/90% improvement in Psoriasis Area and Severity Index (PASI 75/90) and change in Children’s Dermatology Life Quality Index (CDLQI). Serum ustekinumab concentrations, anti‐drug antibodies (ADA), and cytokine levels were measured through week 52. Safety was evaluated through week 56. Results A total of 44 patients (median age, 9.5 years) received at least one dose of ustekinumab. Three patients discontinued study agent through week 40. At week 12, 77.3% of patients achieved PGA 0/1, 84.1% achieved PASI 75, and 63.6% achieved PASI 90 response; mean change in CDLQI was ‐6.3. Trough serum ustekinumab concentrations reached steady state at weeks 28‐52. The incidence of ADA was 9.5% (n=4). Mean serum concentrations of IL‐17A/F and IL‐22 were significantly reduced at weeks 12/52. Overall, 34 patients (77.3%) had at least one adverse event and 3 (6.8%) had a serious adverse event. Conclusions Ustekinumab effectively treated moderate‐to‐severe psoriasis in pediatric patients, and no new safety concerns were identified.