Omalizumab for severe atopic dermatitis in 4- to 19-year-olds: the ADAPT RCT

Background Evidence for systemic treatments severe childhood eczema is limited. Systemic immunosuppressants are unlicensed use in children and associated with unwanted side effects. Objective To examine the role of anti-immunoglobulin E (IgE) [omalizumab (Xolair ® , Novartis Pharmaceuticals UK Ltd, Frimley, UK)] young people eczema. Design A double-blind, placebo-controlled, parallel-arm randomised (1 : 1) trial. Setting single specialist centre – Guy’s St Thomas’ NHS Foundation Trust, London. Participants Atopic (aged 4–19 years) Interventions Treatment omalizumab or placebo 24 weeks. Main outcome measures The primary was severity, measured using objective SCORing Dermatitis (SCORAD) at Secondary outcomes included validated quality life (QoL) potent topical steroid use. Results Sixty-two participants, a median baseline total IgE level 8373 kU/l, received treatment ( n = 30) 32). unadjusted mean SCORAD score week 43.1 [standard deviation (SD) 12.5] participants arm 49.2 (SD 11.3) arm. After adjustment score, age level, difference between arms weeks –6.9 [95% confidence interval (CI) –12.2 to –1.5; p 0.013], favour omalizumab. scores improved by –12.4 –5.1 arms, respectively, measure estimates were also severity weeks: adjusted –8.3 (95% CI –15.1 –1.1; 0.024) combined subjective –6.7 –13.2 –0.1; 0.046) Eczema Area Severity Index, less effect on Patient-Oriented Measure (POEM; –1.1, 95% –4.6 2.4; 0.527). estimate precision limited sample size. QoL favoured omalizumab, an improvement (reduction) both (Children’s) Dermatology Life Quality Index [(C)DLQI] (mean –3.5, –6.4 –0.5; 0.022) Paediatric Allergic Disease Questionnaire –0.5, –0.9 0.0; 0.050). (C)DLQI 50%, from 17.0 5.6) 8.5 5.9) 24, patients treated Improvements seen despite lower arm, 48% more days than (109 vs. 161 arm) twice body surface area coverage (15.5% 31.3% There fewer failures new immunosuppression initiations no numbers cases infective exacerbation. one suspected adverse reaction In each six reported seven events that unrelated treatment. Non-serious respiratory dermatological event rates higher (incidence rate ratio 0.69, 0.49 0.96). Conclusions Omalizumab, highly atopic paediatric population eczema, reduced reduction elevated levels. its favourable profile, warrants further study as option this difficult-to-manage population. Further studies needed clarify benefit became apparent towards persisted after stopped. optimal duration needs be determined. Trial registration This trial registered ISRCTN15090567, EudraCT 2010-020841-29 ClinicalTrials.gov NCT02300701. Funding project funded Efficacy Mechanism Evaluation programme, Medical Research Council National Institute Health Care (NIHR) partnership. will published full ; Vol. 9, No. 5. See NIHR Journals Library website information. grant Charity supported Anti-IgE (ADAPT). Omalizumab supplied Ltd.