Long-term safety and efficacy of secukinumab in paediatric severe plaque psoriasis: 236-week, Phase 3 trial results
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View abstract on PubMed
Summary
This summary is machine-generated.Secukinumab demonstrated sustained efficacy and a favorable safety profile in pediatric patients with severe plaque psoriasis over 236 weeks. This treatment maintained significant improvements in skin clearance and quality of life for children and adolescents.
Area Of Science
- Dermatology
- Immunology
- Clinical Trials
Background
- Plaque psoriasis affects up to 2.1% of children globally, representing a significant public health concern.
- Secukinumab has shown promise in treating severe chronic plaque psoriasis in paediatric populations.
Purpose Of The Study
- To evaluate the final long-term safety and efficacy of secukinumab in paediatric patients with severe chronic plaque psoriasis.
- To assess secukinumab's effectiveness and tolerability over a 236-week treatment period.
Main Methods
- A Phase 3 extension study (NCT02471144) involving paediatric patients (6 to <18 years) with severe chronic plaque psoriasis.
- Patients received either low dose (LD) or high dose (HD) secukinumab throughout the 236-week study, with placebo-to-secukinumab transitions included.
- Key efficacy endpoints included Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) responses, alongside quality of life (CDLQI) and safety assessments.
Main Results
- Secukinumab maintained high efficacy through 236 weeks, with notable PASI 75/90/100 and IGA 0/1 response rates in both LD and HD groups.
- Consistent improvements in Children's Dermatology Life Quality Index (CDLQI) were observed and maintained up to week 236.
- The most frequent adverse events were nasopharyngitis, headache, and tonsillitis, with a generally favorable safety profile. Three cases of Candida infections were reported.
Conclusions
- Secukinumab provides sustained efficacy in treating severe chronic plaque psoriasis in paediatric patients.
- The long-term (236-week) treatment with secukinumab demonstrates a favorable safety profile in this population.
- These findings support the continued use of secukinumab for managing paediatric plaque psoriasis.
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