Ustekinumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients

Data from the CADMUS Jr study, presented by Dr Sandra Phillip (Charité-Universitätsmedizin Berlin, Germany), shows that ustekinumab is a highly effective and safe treatment option for children aged 6-12 years of age [1].

Psoriasis is a common disease and one-third of patients present in childhood. The objective of CADMUS Jr study was to evaluate the efficacy and safety of ustekinumab in paediatric (6-12 years) patients with moderate-to-severe plaque psoriasis. Therapeutic options are limited in those young patients. CADMUS Jr is a phase 3, open-label, single arm, multicentre (20 sites in 7 countries) study. The inclusion criteria were psoriasis area and severity index (PASI) score ≥12, a physician’s global assessment score ≥3, percent body surface area affected by psoriasis ≥0%, and the patients had to be candidates for phototherapy/systemic treatment or considered by the investigator to be poorly controlled with topical therapy. Patients received a weight-based standard dose of ustekinumab administered by subcutaneous injection at weeks 0 and 4 followed by every 12-week dosing through week 40. The primary endpoint was a physician’s global assessment of cleared (0) or minimal (1) at week 12, and major secondary endpoints were PASI-75 response at week 12 and PASI-90 response at week 12. Patients were considered non-responders after discontinuing treatment for lack of efficacy, an adverse event of worsening psoriasis, or use of a prohibited psoriasis treatment; zero improvement was assigned to these cases. After applying treatment failure rules, no other imputation tiles were applied except that patients with missing data at week 12 were considered non-responder. Safety was evaluated through week 56 (see Table). A total of 44 patients were included with a mean age of 8.9 years (range 6-11) and on average they had suffered from the disease 3.5 years on average with a mean PASI score of 17.9, indicating severe disease.

Table: Overview of safety events through week 56. Data from Phillipp (2019).

At week 12 the primary endpoint was reached; 77.3% achieved a physician’s global assessment of cleared (0) or minimal (1) disease at week 12. A PASI-75 response was very good at week 12 in >80% of the patients and a PASI-90 in >60% of the patients. Importantly, this high response was maintained until week 52. The treatment was well tolerated. There were some adverse events mild-to-moderate infections, and only 12 patients had to be treated for them, and there was no patient that had to stop treatment due to adverse events.

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   1. Phillip S, et al. P025, SPIN 2019, 25-27 April, Paris, France.

 

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Posted on 21 June, 201924 March, 2021