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

Presented by
Dr Sandra Phillip, Charité-Universitätsmedizin Berlin, Germany
SPIN 2019
Phase 3, CADMUS Jr
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.

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


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