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Adalimumab is currently FDA approved for use in adult psoriasis, pediatric Crohn's disease and polyarticular juvenile idiopathic arthritis. The current Lancet trial assesses the efficacy and safety of adalimumab in children and adolescents with severe plaque psoriasis.
This multicenter, multinational study enrolled 114 children ages 4 to 18 yrs with severe plaque psoriasis and randomized them to treatment with adalimumab (ADA) (0·8 mg/kg or 0·4 mg/kg subcutaneously)every other week after week 1, or oral methotrexate (MTX) once weekly (0·1–0·4 mg/kg) for 16 weeks.
A week 16 PASI75 was achieved moreso with ADA (58%) compared to MTX (32%).
Clearing or minimal psoriasis was seen with 61% of ADA and 41% of the MTX patients.
There were no unexpected toxicities or infections and 3 serious adverse events were reported, all in patients in the adalimumab 0·4 mg/kg group, and were not judged to be related to study drug.
ADA appears to be effective and safe in children with plaque psoriasis.