Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials.

Abstract

BACKGROUND:

Pain is a frequent symptom of atopic dermatitis (AD).

OBJECTIVES:

The aims of the study were to evaluate the effects of dupilumab on pain/discomfort in AD and to determine whether pain correlates with other outcomes.

METHODS:

This was a post hoc analysis of 5 randomized, placebo-controlled clinical trials in which adults with chronic AD received placebo or dupilumab 300 mg every 2 weeks or once weekly with and without topical corticosteroids. Proportions of patients with no pain/discomfort on this dimension of the 5-dimension EuroQoL (EQ-5D) at week 16 (all trials) and week 52 (CHRONOS) were compared between placebo and dupilumab. Correlations were evaluated between pain/discomfort and signs and symptoms of AD.

RESULTS:

Among 2632 evaluated patients, 72.9% to 83.1% reported at least moderate pain/discomfort at baseline. Higher proportions treated with dupilumab reported no pain/discomfort at week 16 relative to placebo; risk differences ranged from 22.3% (95% confidence interval = 11.5%-33.1%) to 42.2% (95% confidence interval = 26.6%-57.8%, all P ≤ 0.0001), with similar effects observed at week 52. Correlations at baseline of pain/discomfort with signs and symptoms of AD were low to moderate.

CONCLUSIONS:

Pain/discomfort, present in a substantial proportion of patients with moderate-to-severe AD, was significantly reduced by dupilumab treatment. Given the low-to-moderate correlations with other AD symptoms at baseline, pain likely represents a distinct AD symptom.Trial Registration: ClinicalTrials.gov identifiers NCT01859988, NCT02277743, NCT02277769, NCT02260986, and NCT02755649.

• Authors: Jonathan I Silverberg, Eric L Simpson, Emma Guttman-Yassky, Michael J Cork, Marjolein de Bruin-Weller, Gil Yosipovitch, Laurent Eckert, Zhen Chen, Marius Ardeleanu, Brad Shumel, Thomas Hultsch, Ana B Rossi, Jennifer D Hamilton, Jamie M Orengo, Marcella Ruddy, Neil M H Graham, Gianluca Pirozzi, Abhijit Gadkari
• Journal: Dermatitis : contact, atopic, occupational, drug (Dermatitis) Vol. 32 Issue 1S Pg. S81-S91 (Oct 01 2021) ISSN: 2162-5220 [Electronic] United States
• PMID: 33165005 (Publication Type: Journal Article)
• Copyright: Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Contact Dermatitis Society.

Chemical References

• Antibodies, Monoclonal, Humanized
• Dermatologic Agents
• dupilumab

Topics

• Adult
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Clinical Trials, Phase II as Topic
• Clinical Trials, Phase III as Topic
• Dermatitis, Atopic (complications, drug therapy)
• Dermatologic Agents (therapeutic use)
• Double-Blind Method
• Eczema (drug therapy)
• Humans
• Male
• Middle Aged
• Pain (diet therapy, etiology)
• Randomized Controlled Trials as Topic
• Severity of Illness Index
• Treatment Outcome