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
Ustekinumab; treatment of moderate-to-severe plaque psoriasis; CADMUS Jr study; pharmacokinetic and biomarker results; paediatric patients; efficacy and safety
Abstract :
[en] 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 < 12 years of age).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 (< 60 kg: 0 75 mg kg1; ≥ 60 to ≤ 100 kg: 45 mg; > 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’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, antidrug antibodies and cytokine levels were measured through week 52. Safety was evaluated through week 56. s 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.
Disciplines :
Dermatology
Author, co-author :
Philipp, S.
Menter, A.
NIKKELS, Arjen ; Centre Hospitalier Universitaire de Liège - CHU > Autres Services Médicaux > Service de dermatologie
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
Alternative titles :
[en] Ustekinumab pour le traitement de modérée à sévère psoriasis en plaques chez les patients pédiatriques (≥ 6 à <12 ans âge): efficacité, innocuité, pharmacocinétique et biomarqueur résultats de l'étude CADMUS Jr en ouvert
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