Omalizumab is better than placebo in alleviating symptoms in kids with severe atopic dermatitis (ADAPT)

Reference

Chan S, Cornelius V, Cro S, Harper JI, Lack G. Treatment effect of omalizumab on severe pediatric atopic dermatitis: the ADAPT randomized clinical trial. JAMA Pediatr 2019;174(1):29-37.

Synopsis

This study took place in a single referral center in London. The researchers recruited children 4 to 19 years of age with severe atopic dermatitis (based on the Scoring Atopic Dermatitis [SCORAD] index) that persisted despite "optimal topical or systemic therapy" (undefined by the authors). The SCORAD is a 103-point scale. Scores 40 and higher are considered to be severe, and a change of 8.5 is considered to be the minimal clinically important difference. The researchers randomized the children to receive subcutaneous injections of omalizumab (n = 30) or placebo (n = 32). The omalizumab doses were based on manufacturer-provided tables that took into account the child's weight and immunoglobulin E levels. The study medications (omalizumab or placebo) were administered every 2 to 4 weeks. At baseline, the 2 groups were comparable in a whole host of characteristics, including the patient-oriented eczema measure. The authors evaluated the primary outcome - SCORAD change after 24 weeks - using intention-to-treat analysis. The SCORAD score for patients in both groups decreased at the end of 24 weeks (12.4 points for the omalizumab group and 5.1 for the placebo group). However, it appears that whatever gains occurred by the end of 24 weeks were pretty much gone by 48 weeks. This phenomenon was also seen with other symptom and quality-of-life scores. The supplemental use of potent topical corticosteroids was relatively high in each group: Of the 168 days of the study, the authors observed a median of 109 days of use in the omalizumab group and 161 days in the placebo group. The rate of children with one or more infective episodes of atopic dermatitis was similar in each group (20% and 25%, respectively) and the rate of serious adverse events was approximately 20% in each group. One patient treated with omalizumab experienced an anaphylactic reaction.