Sustained long-term efficacy and safety of adalimumab in paediatric patients with severe chronic plaque psoriasis from a randomized, double-blind, phase III study
Abstract
Adalimumab (ADA ) (Humira(R), AbbVie Inc., U.S.A.) is approved by the European Medicines Agency for children aged >= 4 years with severe plaque psoriasis. To evaluate the long-term efficacy and safety of ADA in children with severe plaque psoriasis.
Results are presented from the 52-week long-term extension (LTE ) of the randomized, double-blind, double-dummy, phase III trial, in children with severe plaque psoriasis (results from prior periods have been published). Patients aged >= 4 and = 75% improvement from baseline in Psoriasis Area and Severity Index) was maintained or improved from entry to the end of the LTE : MTX (IT )/ADA 0.8(LTE ) 31-86% of patients; ADA 0.4(IT )/0.4 or 0.8(LTE ) 28-47%; ADA 0.8(IT )/0.8(LTE ) 50-72%.
No serious infections occurred in the LTE. After 52 weeks of long-term ADA treatment in children aged 4-18 years with severe plaque psoriasis, disease severity was reduced and maintained or further improved, as demonstrated by efficacy outcomes.
No new safety risks were identified.