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Clinical Trial
. 2023 Nov 16;189(6):685-694.
doi: 10.1093/bjd/ljad284.

Dupilumab significantly improves sleep in adults with atopic dermatitis: results from the 12-week placebo-controlled period of the 24-week phase IV randomized double-blinded placebo-controlled DUPISTAD study

Joseph F Merola  1   2 , Albert S Chiou  3 , Emmanuel During  4   5 , Antonio Costanzo  6 , Peter Foley  7   8   9 , Amani Alfalasi  10 , Shaila Gogate  11 , Andreas Pinter  12 , Roni Dodiuk-Gad  13   14   15 , Dagmar Simon  16 , Marie Tauber  17 , Richard Weller  18 , Jose-Juan Pereyra-Rodriguez  19 , Marius Ardeleanu  20 , Jiangming Wu  21 , Zafer E Ozturk  22
Affiliations
Free article
Clinical Trial

Dupilumab significantly improves sleep in adults with atopic dermatitis: results from the 12-week placebo-controlled period of the 24-week phase IV randomized double-blinded placebo-controlled DUPISTAD study

Joseph F Merola et al. Br J Dermatol. .
Free article

Abstract

Background: Sleep disturbance is a prominent symptom of atopic dermatitis (AD) and can result in insomnia, daytime fatigue, drowsiness, reduced productivity and impaired quality of life (QoL).

Objectives: The Dupilumab Effect on Sleep in AD Patients (DUPISTAD) phase IV randomized double-blinded placebo-controlled study evaluated the impact of dupilumab treatment on sleep and other patient- and physician-reported outcomes.

Methods: Adults with moderate-to-severe AD were randomized 2 : 1 to dupilumab 300 mg once every 2 weeks (q2w) or placebo for 12 weeks; concomitant topical corticosteroids were permitted. Patients subsequently entered an open-label phase and received dupilumab 300 mg q2w for a further 12 weeks. The primary endpoint was the percentage change in sleep quality from baseline to week 12, assessed using a novel numeric rating scale (NRS). Secondary and exploratory endpoints included percentage change in peak pruritus NRS (PP NRS), change in SCORing Atopic Dermatitis (SCORAD), SCORAD sleep visual analogue scale (VAS), Eczema Area and Severity Index, Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment T-score and the Epworth Sleepiness Scale. Sleep diary and wrist actigraphy measurements were recorded throughout the study.

Results: In total, 127 patients received dupilumab and 61 patients received placebo. Demographic and baseline disease characteristics were balanced between groups. Sleep quality NRS significantly improved in patients treated with dupilumab by week 12 vs. placebo [least squares mean of the difference (LSMD) -15.5%, P < 0.001]. PP NRS (LSMD -27.9%, P < 0.001), SCORAD (LSMD -15.1, P < 0.001), SCORAD sleep VAS (LSMD -2.1, P < 0.001) and PROMIS T-score (LSMD -3.6, P < 0.001) were also significantly improved at week 12 with dupilumab vs. placebo. The overall percentage of patients reporting treatment-emergent adverse events was lower in the dupilumab group (56.7%) than in the placebo group (67.2%).

Conclusions: Dupilumab significantly improved sleep quality and perception of sleep continuity, itch, metrics of AD severity and QoL in adults with moderate-to-severe AD, with an acceptable safety profile compared with placebo.

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Conflict of interest statement

Conflicts of interest J.F.M. has been a principal investigator, advisory board member and consultant for Regeneron Pharmaceuticals Inc. and Sanofi. A.S.C. has been a principal investigator for Regeneron Pharmaceuticals Inc., Sanofi and AbbVie, in addition to working as an advisory board member for Pfizer. E.D. has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi. A.C. has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi. P.F. has received grant support from AbbVie, Amgen, BMS, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sanofi and Sun Pharma. P.F. has also been an investigator for AbbVie, Akaal Pharma, Amgen, Arcutis, Argenx, Aslan Pharmaceuticals, AstraZeneca, BMS, Boehringer Ingelheim, Botanix, Celgene, Celtaxsys, CSL, Cutanea, Dermira, Eli Lilly, Galderma, Genentech, Geneseq Biosciences, GSK, Hexima, Janssen, Kymab, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Reistone Biopharma, Roche, Sanofi, Sun Pharma, Teva, UCB Pharma and Valeant. P.F. has also been an advisory board member for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, Mayne Pharma, Merck, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma and Valeant, and has been a consultant for Aslan Pharmaceuticals, BMS, Eli Lilly, Galderma, GenesisCare, Janssen, LEO Pharma, Mayne Pharma, MedImmune, Novartis, Pfizer, Roche and UCB Pharma. P.F. has received travel grants from AbbVie, Eli Lilly, Galderma, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Roche, Sanofi and Sun Pharma, and has been a speaker for AbbVie, Amgen, BMS, Celgene, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Roche, Sanofi, Sun Pharma and Valeant. A.A. has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi. S.G. has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi. A.P. has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi and has served as an advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Almirall-Hermal, Amgen, Biogen Idec, BioNTech, Boehringer Ingelheim, Celgene, Celltrion, GSK, Eli Lilly, Galderma, Hexal, Janssen, Klinge Pharma, LEO Pharma, MC2, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pascoe, Pfizer, Tigercat Pharma, Regeneron Pharmaceuticals Inc., Roche, Sandoz Biopharmaceuticals, Sanofi, Schering-Plough and UCB Pharma. R.D-G. has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi. D.S. has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi. M.T. has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi and has been a consultant and/or speaker for AbbVie, Eli Lilly, Janssen, Medac and Sanofi. R.W. has received speaker fees or meeting attendance support from AbbVie, LEO Pharma, Eli Lilly and Pfizer and has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi. J.-J.P.-R. has been a principal investigator for Regeneron Pharmaceuticals Inc. and Sanofi and has been a consultant and/or investigator for AbbVie, Amgen, Biogen, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer and UCB Pharma. M.A. is an employee and shareholder of Regeneron Pharmaceuticals Inc. J.W. is an employee of and may hold stock and/or stock options in Sanofi. Z.E.O. is an employee of and may hold stock and/or stock options in Sanofi.

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