Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal
Aim Blauvelt et al. (The Lancet 2017; 389: 2287-303) aimed to compare the long-term efficacy and safety of dupilumab with medium-potency topical corticosteroids (TCS) versus placebo with TCS in adults with moderate-to-severe atopic dermatitis (AD). Setting and design This multicentre random...
| Main Authors: | , , |
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| Format: | Article |
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Wiley
2018
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| Online Access: | https://eprints.nottingham.ac.uk/48981/ |
| _version_ | 1848797894701744128 |
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| author | Thomson, J. Wernham, A.G.H. Williams, Hywel C. |
| author_facet | Thomson, J. Wernham, A.G.H. Williams, Hywel C. |
| author_sort | Thomson, J. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Aim
Blauvelt et al. (The Lancet 2017; 389: 2287-303) aimed to compare the long-term efficacy and safety of dupilumab with medium-potency topical corticosteroids (TCS) versus placebo with TCS in adults with moderate-to-severe atopic dermatitis (AD).
Setting and design
This multicentre randomised, double-blinded, placebo-controlled trial was conducted in hospitals, clinics and academic institutions across 161 sites in 14 countries.
Study exposure
Adults with moderate-to-severe AD were randomly assigned (3:1:3) to receive subcutaneous dupilumab 300mg once weekly (qw) plus TCS, dupilumab 300mg every 2 weeks (q2w) plus TCS, or placebo plus TCS until week-52.
Primary outcome measures
Co-primary efficacy endpoints were patients (%) achieving Investigator's Global Assessment (IGA) 0/1 and 2-points or higher improvement from baseline, and Eczema Area and Severity Index 75% improvement from baseline (EASI-75) at week-16.
Results
740 patients were included in the trial: 319 were randomly assigned to dupilumab qw, 106 to dupilumab q2w and 315 to the placebo arm. At week-16, more patients in the dupilumab groups achieved the co-primary endpoints: IGA 0/1 (39% [125 patients] qw dosing, 39% [41 patients] q2w dosing vs 12% [39 patients] receiving placebo; p<0.0001) and EASI-75 (64% [204] and 69% [73] vs 23% [73]; p<0.0001). Whilst no new safety signals were identified, adverse effects (AEs) were noted in 261 (83%) in those receiving dupilumab qw plus TCS, 97 (88%) dupilumab q2w plus TCS and 266 (84%) for placebo plus TCS. Rates of conjunctivitis, injection site reactions and local herpes simplex infections were higher in the dupilumab groups compared with placebo.
Conclusions
Blauvelt et al. concluded that dupilumab treatment added to TCS improved AD up to week-52 compared with TCS alone, and also demonstrated acceptable safety. |
| first_indexed | 2025-11-14T20:11:08Z |
| format | Article |
| id | nottingham-48981 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:11:08Z |
| publishDate | 2018 |
| publisher | Wiley |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-489812024-08-15T15:28:23Z https://eprints.nottingham.ac.uk/48981/ Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal Thomson, J. Wernham, A.G.H. Williams, Hywel C. Aim Blauvelt et al. (The Lancet 2017; 389: 2287-303) aimed to compare the long-term efficacy and safety of dupilumab with medium-potency topical corticosteroids (TCS) versus placebo with TCS in adults with moderate-to-severe atopic dermatitis (AD). Setting and design This multicentre randomised, double-blinded, placebo-controlled trial was conducted in hospitals, clinics and academic institutions across 161 sites in 14 countries. Study exposure Adults with moderate-to-severe AD were randomly assigned (3:1:3) to receive subcutaneous dupilumab 300mg once weekly (qw) plus TCS, dupilumab 300mg every 2 weeks (q2w) plus TCS, or placebo plus TCS until week-52. Primary outcome measures Co-primary efficacy endpoints were patients (%) achieving Investigator's Global Assessment (IGA) 0/1 and 2-points or higher improvement from baseline, and Eczema Area and Severity Index 75% improvement from baseline (EASI-75) at week-16. Results 740 patients were included in the trial: 319 were randomly assigned to dupilumab qw, 106 to dupilumab q2w and 315 to the placebo arm. At week-16, more patients in the dupilumab groups achieved the co-primary endpoints: IGA 0/1 (39% [125 patients] qw dosing, 39% [41 patients] q2w dosing vs 12% [39 patients] receiving placebo; p<0.0001) and EASI-75 (64% [204] and 69% [73] vs 23% [73]; p<0.0001). Whilst no new safety signals were identified, adverse effects (AEs) were noted in 261 (83%) in those receiving dupilumab qw plus TCS, 97 (88%) dupilumab q2w plus TCS and 266 (84%) for placebo plus TCS. Rates of conjunctivitis, injection site reactions and local herpes simplex infections were higher in the dupilumab groups compared with placebo. Conclusions Blauvelt et al. concluded that dupilumab treatment added to TCS improved AD up to week-52 compared with TCS alone, and also demonstrated acceptable safety. Wiley 2018-04-30 Article PeerReviewed Thomson, J., Wernham, A.G.H. and Williams, Hywel C. (2018) Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal. British Journal of Dermatology, 178 (4). pp. 897-902. ISSN 1365-2133 http://onlinelibrary.wiley.com/doi/10.1111/bjd.16317/full doi:10.1111/bjd.16317 doi:10.1111/bjd.16317 |
| spellingShingle | Thomson, J. Wernham, A.G.H. Williams, Hywel C. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal |
| title | Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal |
| title_full | Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal |
| title_fullStr | Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal |
| title_full_unstemmed | Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal |
| title_short | Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal |
| title_sort | long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (liberty ad chronos): a critical appraisal |
| url | https://eprints.nottingham.ac.uk/48981/ https://eprints.nottingham.ac.uk/48981/ https://eprints.nottingham.ac.uk/48981/ |