Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis
DC Field | Value | Language |
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dc.contributor.author | Beck, L.A. | - |
dc.contributor.author | Deleuran, M. | - |
dc.contributor.author | Bissonnette, R. | - |
dc.contributor.author | de, Bruin-Weller M. | - |
dc.contributor.author | Galus, R. | - |
dc.contributor.author | Nakahara, T. | - |
dc.contributor.author | Seo, S.J. | - |
dc.contributor.author | Khokhar, F.A. | - |
dc.contributor.author | Vakil, J. | - |
dc.contributor.author | Xiao, J. | - |
dc.contributor.author | Marco, A.R. | - |
dc.contributor.author | Levit, N.A. | - |
dc.contributor.author | O’Malley, J.T. | - |
dc.contributor.author | Shabbir, A. | - |
dc.date.accessioned | 2023-03-08T07:21:06Z | - |
dc.date.available | 2023-03-08T07:21:06Z | - |
dc.date.issued | 2022-05 | - |
dc.identifier.issn | 1175-0561 | - |
dc.identifier.issn | 1179-1888 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/61381 | - |
dc.description.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). | - |
dc.format.extent | 16 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | Adis | - |
dc.title | Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis | - |
dc.type | Article | - |
dc.identifier.doi | 10.1007/s40257-022-00685-0 | - |
dc.identifier.bibliographicCitation | American Journal of Clinical Dermatology, v.23, no.3, pp 393 - 408 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.wosid | 000790248300001 | - |
dc.identifier.scopusid | 2-s2.0-85129254053 | - |
dc.citation.endPage | 408 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 393 | - |
dc.citation.title | American Journal of Clinical Dermatology | - |
dc.citation.volume | 23 | - |
dc.type.docType | Article | - |
dc.publisher.location | 뉴질랜드 | - |
dc.subject.keywordPlus | PLACEBO | - |
dc.subject.keywordPlus | HUMANIZATION | - |
dc.subject.keywordPlus | MANAGEMENT | - |
dc.relation.journalResearchArea | Dermatology | - |
dc.relation.journalWebOfScienceCategory | Dermatology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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