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 â„12, a physicianâs global assessment score â„3, percent body surface area affected by psoriasis â„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 physicianâs 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 physicianâs 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.
- Phillip S, et al. P025, SPIN 2019, 25-27 April, Paris, France.
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Table of Contents: SPIN 2019
Featured articles
Letter from the Editor
Aetiology: Triggers and Risk Factors
Understanding genetics to unravel psoriasis and atopic dermatitis pathogenesis
Atopic dermatitis and psoriasis: on a spectrum?
Advances in Therapy
Advances in target-oriented therapy: psoriatic arthritis
Favourable safety profile of long-term use of ixekizumab
Brodalumab onset of action is significantly faster than ustekinumab: Results from the phase 3 AMAGINE-2 and -3 studies
Adalimumab vs adalimumab + methotrexate in psoriasis: First-year results on effectiveness, drug survival, safety, and immunogenicity
Ustekinumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients
Fumarates and vitamin A derivatives advance and latest insights in non-biologic systemic therapeutic agents in psoriasis and atopic dermatitis
Certolizumab: Long-term safety and efficacy results for psoriasis-related nail disease
Novel Considerations
Granulomatous rosacea: exploratory histological markers
Live imaging of cutaneous immune responses
Results from the ECLIPSE trial: does blocking IL-23 have better long-term outcomes in psoriasis?
ABP501 biosimilar for adalimumab: What you need to know
Sustained and complete responses from the phase 3 AMAGINE-2 and -3 studies
Reduction in coronary artery disease in psoriasis patients treated with biologic therapies, possible implications for atopic dermatitis
Small molecules, apremilast, and TYK2
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