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:

Background

Adalimumab (ADA) (Humira^® , AbbVie Inc., U.S.A.) is approved by the European Medicines Agency for children aged ≥ 4 years with severe plaque psoriasis.

Objectives

To evaluate the long-term efficacy and safety of ADA in children with severe plaque psoriasis.

Methods

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 < 18 years were randomized 1 : 1 : 1 to ADA 0·8 mg kg^-1 (40 mg maximum) or 0·4 mg kg^-1 (20 mg maximum) every other week or to methotrexate (MTX) 0·1-0·4 mg kg^-1 (25 mg maximum) weekly. The 16-week initial treatment

SUBMITTER: Thaci D 

PROVIDER: S-EPMC6916374 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature