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.

Abstract

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.

Citation

Thomson, J., Wernham, A., & Williams, H. 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), 897-902. https://doi.org/10.1111/bjd.16317

• Journal Article Type: Article
• Acceptance Date: Jan 3, 2018
• Online Publication Date: Jan 6, 2018
• Publication Date: Apr 30, 2018
• Deposit Date: Jan 8, 2018
• Publicly Available Date: Jan 7, 2019
• Journal: British Journal of Dermatology
• Print ISSN: 0007-0963
• Electronic ISSN: 1365-2133
• Publisher: Oxford University Press (OUP)
• Peer Reviewed: Peer Reviewed
• Volume: 178
• Issue: 4
• Pages: 897-902
• DOI: https://doi.org/10.1111/bjd.16317
• Public URL: https://nottingham-repository.worktribe.com/output/930156
• Publisher URL: http://onlinelibrary.wiley.com/doi/10.1111/bjd.16317/full
• Additional Information: This is the peer reviewed version of the following article: Thomson, J., Wernham, A.G.H. and Williams, H.C. (2018), Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal. Br J Dermatol. doi:10.1111/bjd.16317, which has been published in final form at http://onlinelibrary.wiley.com/doi/10.1111/bjd.16317/full. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
• Contract Date: Jan 8, 2018