Efficacy and Safety of Dupilumab Maintained in Adults ≥ 60 Years of Age with Moderate-to-Severe Atopic Dermatitis: Analysis of Pooled Data from Four Randomized Clinical Trials.

Autor: Silverberg JI; Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA., Lynde CW; University of Toronto, Markham, ON, Canada.; Lynderm Research, Markham, ON, Canada., Abuabara K; Department of Dermatology, University of California San Francisco, San Francisco, CA, USA., Patruno C; Department of Health Sciences, Magna Graecia University, Catanzaro, Italy., de Benedetto A; Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA., Zhang H; Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA., Thomas RB; Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA., Bégo-Le-Bagousse G; Sanofi, Chilly-Mazarin, France., Khokhar FA; Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA., Vakil J; Sanofi, Bridgewater, NJ, USA., Marco AR; Sanofi, Madrid, Spain., Levit NA; Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA. noah.levit@regeneron.com.
Jazyk: angličtina
Zdroj: American journal of clinical dermatology [Am J Clin Dermatol] 2023 May; Vol. 24 (3), pp. 469-483. Date of Electronic Publication: 2023 Feb 20.
DOI: 10.1007/s40257-022-00754-4
Abstrakt: Background: Adults aged ≥ 60 years are often underrepresented in atopic dermatitis (AD) clinical trials; age-related comorbidities may impact treatment efficacy and safety.
Objective: The aim was to report dupilumab efficacy and safety in patients aged ≥ 60 years with moderate-to-severe AD.
Methods: Data were pooled from four randomized, placebo-controlled dupilumab trials of patients with moderate-to-severe AD (LIBERTY AD SOLO 1 and 2, LIBERTY AD CAFÉ, and LIBERTY AD CHRONOS) and stratified by age (< 60 [N = 2261] and ≥ 60 [N = 183] years). Patients received dupilumab 300 mg every week (qw) or every 2 weeks (q2w), or placebo with/without topical corticosteroids. Post hoc efficacy at week 16 was examined using broad categorical and continuous assessments of skin lesions, symptoms, biomarkers, and quality of life. Safety was also assessed.
Results: In the ≥ 60-year-old group at week 16, a greater proportion of dupilumab-treated patients achieved an Investigator's Global Assessment score of 0/1 (q2w: 44.4%; qw: 39.7%) and 75% improvement in Eczema Area and Severity Index (63.0%; 61.6%) versus placebo (7.1% and 14.3%, respectively; P < 0.0001). Type 2 inflammation biomarkers (immunoglobulin E and thymus and activation-regulated chemokine) were also significantly reduced in dupilumab- versus placebo-treated patients (P < 0.01). Results were similar in the < 60-year-old group. The exposure-adjusted incidences of adverse events in dupilumab-treated patients were generally similar to those receiving placebo, with numerically fewer treatment-emergent adverse events in the dupilumab-treated ≥ 60-year-old group versus placebo.
Limitations: There were fewer patients in the ≥ 60-year-old group; post hoc analyses.
Conclusion: Dupilumab improved AD signs and symptoms in patients aged ≥ 60 years; results were comparable to those in patients aged < 60 years. Safety was consistent with the known dupilumab safety profile.
Trial Registration: ClinicalTrials.gov: NCT02277743, NCT02277769, NCT02755649, NCT02260986. Does dupilumab benefit adults aged 60 years and older with moderate-to-severe atopic dermatitis?(MP4 20,787 KB).
(© 2023. The Author(s).)
Databáze: MEDLINE
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