TY - JOUR
T1 - Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis
T2 - A Post Hoc Analysis of 5 Randomized Clinical Trials
AU - Silverberg, Jonathan I.
AU - Simpson, Eric L.
AU - Guttman-Yassky, Emma
AU - Cork, Michael J.
AU - De Bruin-Weller, Marjolein
AU - Yosipovitch, Gil
AU - Eckert, Laurent
AU - Chen, Zhen
AU - Ardeleanu, Marius
AU - Shumel, Brad
AU - Hultsch, Thomas
AU - Rossi, Ana B.
AU - Hamilton, Jennifer D.
AU - Orengo, Jamie M.
AU - Ruddy, Marcella
AU - Graham, Neil M.H.
AU - Pirozzi, Gianluca
AU - Gadkari, Abhijit
N1 - Funding Information:
The study was supported by Sanofi (Bridgewater, NJ) and Regeneron Pharmaceuticals, Inc (Tarrytown, NY).
Publisher Copyright:
© Lippincott Williams & Wilkins.
PY - 2021/10/1
Y1 - 2021/10/1
N2 - 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.
AB - 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.
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U2 - 10.1097/DER.0000000000000698
DO - 10.1097/DER.0000000000000698
M3 - Article
C2 - 33165005
AN - SCOPUS:85120720788
SN - 1710-3568
VL - 32
SP - S81-S91
JO - Dermatitis
JF - Dermatitis
IS - 1
ER -