The Food and Drug Administration (FDA) has expanded the approval of Humira (adalimumab) for the treatment of uveitis to include pediatric patients ≥2 years old.
The approval was based on data from a randomized, double-masked, placebo-controlled study of 90 pediatric patients aged 2 to <18 years with active JIA-associated non-infectious uveitis. Patients received either placebo (N=30) or adalimumab (N=60) 20mg (if <30kg) or 40mg (if ≥30kg) every other week in combination with a dose of methotrexate. The primary endpoint was “time to treatment failure,” defined as worsening or sustained non-improvement in ocular inflammation, or worsening of ocular co-morbidities.
Results showed that adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo (hazard ratio: 0.25 [95% CI, 0.12, 0.49]).
The recommended dose of Humira for patients ≥2 years old with pediatric uveitis is based on weight; the treatment has not been studied in patients <2 years of age or in those with a weight <10kg.
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