[en] Psoriasis affects approximately 1% of the paediatric population1-3, negatively impacts the quality of life and affects long-term psychological well-being4.
Secukinumab is efficacious in children 6 to <18 years of age with severe and moderate to severe chronic plaque psoriasis5,6. The EMA and USFDA have approved secukinumab for the treatment of moderate to severe plaque psoriasis in children aged ≥6 years of age 7,8.
Long-term pooled safety data for secukinumab in adults with moderate to
severe plaque psoriasis have been reported earlier9 ; however, its safety profile in a large pool of paediatric patients is yet to be investigated.
Here, we report a pooled safety analysis from two Phase 3 (NCT02471144 and NCT03668613) studies up to 52 weeks in paediatric patients with moderate to severe chronic plaque psoriasis. Data from four pivotal studies (NCT01365455, NCT01358578, NCT01555125 and NCT01636687) in the adult population were also pooled to present alongside the results from the pooled paediatric safety dataset.
Disciplines :
Dermatology
Author, co-author :
Sticherling, M.; Universitätsklinikum Erlangen > Hautklinik > Hautklinik
NIKKELS, Arjen ; Centre Hospitalier Universitaire de Liège - CHU > Autres Services Médicaux > Service de dermatologie
Hamza, AM.; Alexandria University, Alexandria, Egypt > Department of Dermatology & Andrology
Kwong, P.; Solutions through Advanced Research, Jacksonville, FL, United States
Keefe, D.; Novartis Pharmaceuticals Corp., East Hanover, NJ, United States
Language :
English
Title :
Pooled Safety Analysis from Phase 3 Studies of Secukinumab in Paediatric Patients with Moderate to Severe Plaque Psoriasis
Alternative titles :
[en] Analyse groupée de l'innocuité des études de phase 3 du sécukinumab chez des patients pédiatriques atteints de psoriasis en plaques modéré à sévère
Publication date :
29 September 2021
Event name :
30e congrès de l'European Academy of Dermatology and Venereology
Event organizer :
European Academy of Dermatology and Venereology (EADV)
