Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitisopen access
- Authors
- Beck, L.A.; Deleuran, M.; Bissonnette, R.; de, Bruin-Weller M.; Galus, R.; Nakahara, T.; Seo, S.J.; Khokhar, F.A.; Vakil, J.; Xiao, J.; Marco, A.R.; Levit, N.A.; O’Malley, J.T.; Shabbir, A.
- Issue Date
- May-2022
- Publisher
- Adis
- Citation
- American Journal of Clinical Dermatology, v.23, no.3, pp 393 - 408
- Pages
- 16
- Journal Title
- American Journal of Clinical Dermatology
- Volume
- 23
- Number
- 3
- Start Page
- 393
- End Page
- 408
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/61381
- DOI
- 10.1007/s40257-022-00685-0
- ISSN
- 1175-0561
1179-1888
- Abstract
- Background: Moderate‐to‐severe atopic dermatitis (AD) often requires long-term management with systemic therapies. Objective: Our objective was to report the safety and efficacy of dupilumab treatment up to 4 years in adults with moderate-to-severe AD and efficacy in a subgroup of patients who transitioned from dupilumab once-weekly (qw) to administration every other week (q2w). Methods: This interim analysis of the open-label extension study (NCT01949311) evaluated dupilumab 300 mg qw or q2w in adults previously enrolled in dupilumab trials for moderate-to-severe AD. Patients switched from qw to q2w following protocol amendment. The primary outcome was safety; efficacy was also assessed. Results: Of 2677 patients enrolled and treated, 352 (13.1%) completed week 204 (end of efficacy assessments) and 202 (7.5%) completed safety follow-up through week 244. Self-reported compliance was 98.1%. Dupilumab’s safety profile was consistent with previous reports. Common treatment-emergent adverse events (≥5%) included nasopharyngitis, AD, upper respiratory tract infection, oral herpes, conjunctivitis, injection-site reaction, and headache. At week 204, mean ± standard deviation (SD) Eczema Area and Severity Index was 2.46 ± 3.98, and mean percent change from parent study baseline (PSBL) was −91.07%; mean ± SD Pruritus Numerical Rating Scale score was 2.10 ± 1.83, and mean percent change from PSBL was −68.74%. Efficacy was maintained in patients (n = 226) who transitioned from qw to q2w dosing. Limitations of this study included its open-label design, the lack of control arm, and smaller subsets of patients at later timepoints and receiving the approved q2w regimen. Conclusion: These results support dupilumab as continuous long-term treatment for adults with moderate-to-severe AD; efficacy was sustained following transition from qw to q2w dosing. Trial Registration ClinicalTrials.gov: NCT01949311. © 2022, The Author(s).
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