Imperial College London
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ProfessorVictoriaCornelius

Faculty of Medicine, School of Public Health

Professor in Medical Statistics and Trials Methodology
 
 
 
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Contact

 

+44 (0)20 7594 1218v.cornelius

 
 
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Assistant

 

Mrs Ranjit Rayat +44 (0)20 7594 3445

 
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Location

 

111Stadium HouseWhite City Campus

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Summary

 

Publications

Citation

BibTex format

@article{Chan:2022:10.3310/wcxn5739,
author = {Chan, SMH and Cro, S and Cornelius, V and Jahan, R and Radulovic, S and Lack, G},
doi = {10.3310/wcxn5739},
journal = {Efficacy and Mechanism Evaluation},
pages = {1--110},
title = {Omalizumab for severe atopic dermatitis in 4- to 19-year-olds: the ADAPT RCT},
url = {http://dx.doi.org/10.3310/wcxn5739},
volume = {9},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - AbstractBackgroundEvidence for systemic treatments for severe childhood eczema is limited. Systemic immunosuppressants are unlicensed for use in children and are associated with unwanted side effects.ObjectiveTo examine the role of anti-immunoglobulin E (IgE) [omalizumab (Xolair®, Novartis Pharmaceuticals UK Ltd, Frimley, UK)] in children and young people with severe eczema.DesignA double-blind, placebo-controlled, parallel-arm randomised (1 : 1) trial.SettingA single specialist centre – Guy’s and St Thomas’ NHS Foundation Trust, London.ParticipantsAtopic children and young people (aged 4–19 years) with severe eczema.InterventionsTreatment with omalizumab or placebo for 24 weeks.Main outcome measuresThe primary outcome was eczema severity, measured using the objective SCORing Atopic Dermatitis (SCORAD) at 24 weeks. Secondary outcomes included validated measures of eczema severity, quality of life (QoL) and potent topical steroid use.ResultsSixty-two participants, with a median baseline total IgE level of 8373 kU/l, received treatment with omalizumab (n = 30) or placebo (n = 32). The unadjusted mean objective SCORAD score at week 24 was 43.1 [standard deviation (SD) 12.5] for participants in the omalizumab arm and 49.2 (SD 11.3) for participants in the placebo arm. After adjustment for baseline objective SCORAD score, age and IgE level, the mean difference between arms at 24 weeks was –6.9 [95% confidence interval (CI) –12.2 to –1.5; p = 0.013], in favour of omalizumab. The mean objective SCORAD scores improved by –12.4 and –5.1 in the omalizumab and placebo arms, respectively, by 24 weeks. Secondary outcome measure estimates were also in favour of omalizumab for eczema severity at 24 weeks: the adjusted mean treatment arm difference was –8.3 (95% CI –15.1 to –1.1; p = 0.024) for total combined objective and subjecti
AU  - Chan,SMH
AU  - Cro,S
AU  - Cornelius,V
AU  - Jahan,R
AU  - Radulovic,S
AU  - Lack,G
DO  - 10.3310/wcxn5739
EP  - 110
PY  - 2022///
SN  - 2050-4365
SP  - 1
TI  - Omalizumab for severe atopic dermatitis in 4- to 19-year-olds: the ADAPT RCT
T2  - Efficacy and Mechanism Evaluation
UR  - http://dx.doi.org/10.3310/wcxn5739
UR  - https://www.journalslibrary.nihr.ac.uk/eme/WCXN5739#/abstract
UR  - http://hdl.handle.net/10044/1/97900
VL  - 9
ER  -
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