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

• Published in: Dermatitis Vol. 32; no. 1S; p. S81
• Main Authors: Silverberg, Jonathan I, Simpson, Eric L, Guttman-Yassky, Emma, Cork, Michael J, de Bruin-Weller, Marjolein, Yosipovitch, Gil, Eckert, Laurent, Chen, Zhen, Ardeleanu, Marius, Shumel, Brad, Hultsch, Thomas, Rossi, Ana B, Hamilton, Jennifer D, Orengo, Jamie M, Ruddy, Marcella, Graham, Neil M H, Pirozzi, Gianluca, Gadkari, Abhijit
• Format: Journal Article
• Language: English
• Published: United States 01.10.2021
• Subjects: Adult; Antibodies, Monoclonal, Humanized - therapeutic use; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Dermatitis, Atopic - complications; Dermatitis, Atopic - drug therapy; Dermatologic Agents - therapeutic use; Double-Blind Method; Eczema - drug therapy; Humans; Male; Middle Aged; Pain - diet therapy; Pain - etiology; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome
• ISSN: 2162-5220
• DOI: 10.1097/DER.0000000000000698

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