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. (1st October 2020)

• Record Type: Journal Article
• Authors: Philipp, S.; Menter, A.; Nikkels, A.F.; Barber, K.; Landells, I.; Eichenfield, L.F.; Song, M.; Randazzo, B.; Li, S.; Hsu, M.‐C.; Zhu, Y.; DePrimo, S.; Paller, A.S.
• Is Part Of: British journal of dermatology. Volume 183:Number 4(2020)
• Page Start: 664
• Page End: 672
• Publication Date: 2020-10-01
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.19018
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Limited options are available for treatment of paediatric psoriasis. Objectives: To evaluate the efficacy and safety of ustekinumab in paediatric patients with psoriasis (≥ 6 to &lt; 12 years of age). Methods: CADMUS Jr, a phase III, open‐label, single‐arm, multicentre study, evaluated ustekinumab in paediatric patients with moderate‐to‐severe plaque psoriasis. Patients received weight‐based dosing of ustekinumab (&lt; 60 kg: 0·75 mg kg −1 ; ≥ 60 to ≤ 100 kg: 45 mg; &gt; 100 kg: 90 mg) administered by subcutaneous injection at weeks 0 and 4, then every 12 weeks through week 40. Study endpoints (all at week 12) included the proportions of patients achieving a Physician&#39;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&#39;s Dermatology Life Quality Index (CDLQI). Serum ustekinumab concentrations, antidrug antibodies and cytokine levels were measured through week 52. Safety was evaluated through week 56. Results: In total, 44 patients (median age 9·5 years) received at least one dose of ustekinumab. Three patients discontinued the study agent through week 40. At week 12, 77% of patients achieved PGA 0/1, 84% achieved PASI 75 and 64% achieved PASI 90 response. The mean change in CDLQI was −6·3. Trough serum ustekinumab concentrations reached steady state at weeks 28–52. The incidence of antidrug antibodies was 10% ( n = 4). Mean serum concentrations of interleukin‐17A/F and interleukin‐22 were significantly reduced at weeks 12 and 52. Overall, 34 patients (77%) had at least one adverse event and three (7%) had a serious adverse event. Conclusions: Ustekinumab effectively treated moderate‐to‐severe psoriasis in paediatric patients, and no new safety concerns were identified. What is already known about this topic? Ustekinumab is approved for use in adolescents (≥ 12 to &lt; 18 years of age) and adults (≥ 18 years) with moderate‐to‐severe psoriasis. What does this study add? Ustekinumab effectively treats moderate‐to‐severe psoriasis in paediatric patients (≥ 6 to &lt; 12 years of age), with no new safety concerns. Linked Comment: Reich. Br J Dermatol 2020; 183 :606–607 .