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在韩国,52 周的度普利尤单抗治疗中重度特应性皮炎:真实世界中的长期疗效和安全性。

A 52 weeks dupilumab treatment for moderate to severe atopic dermatitis in Korea: long-term efficacy and safety in real world.

机构信息

Department of Dermatology, National Medical Center, 245 Eulji-ro, Jung-gu, Seoul, 04564, Korea.

Department of Biostatistics and Computing, Yonsei University Graduate School, Seoul, Korea.

出版信息

Sci Rep. 2021 Dec 7;11(1):23539. doi: 10.1038/s41598-021-02950-4.

Abstract

Previously, we have reported short term effectiveness and safety of dupilumab in Korea. In this study, we are trying to report the long-term effectiveness and safety of dupilumab in Korea. Ninety-nine patients with moderate to severe AD were analyzed. They were evaluated using Eczema Area and Severity Index (EASI), Numerical Rating Scale (NRS), Patient Oriented Eczema Measure (POEM), and Dermatology Quality of Life Index (DLQI) at baseline, week 16, 32 and 52. Efficacy outcomes showed higher improvement at 52 weeks compared with 16 weeks; high percentual reductions in EASI (88.1%), peak pruritus NRS (65.6%), POEM (67.2%), and DLQI (69.0%) compared to baseline. Proportion of patients achieving EASI 75 and 90 were 90.2% and 53.7%. POEM and DLQI had high correlation with clinical measured outcomes. In the analysis for the factors affecting achievement of EASI 90, female gender (OR 2.5), eosinophilia (OR 0.2) and elevated LDH (OR 0.07) were significantly associated. Most frequent adverse events included facial erythema (19.2%) and conjunctivitis (17.2%), which were mild/moderate and resolved during treatment. In conclusion, dupilumab treatment for 52 weeks in Korean patients with moderate-to-severe AD confirmed long term effectiveness and safety.

摘要

先前,我们已经报告了度普利尤单抗在韩国的短期疗效和安全性。在这项研究中,我们试图报告度普利尤单抗在韩国的长期疗效和安全性。分析了 99 名中重度 AD 患者。他们在基线、16 周、32 周和 52 周时使用湿疹面积和严重程度指数(EASI)、数字评分量表(NRS)、患者为中心的湿疹量表(POEM)和皮肤病生活质量指数(DLQI)进行评估。疗效结果显示,52 周时的改善高于 16 周;EASI(88.1%)、瘙痒峰值 NRS(65.6%)、POEM(67.2%)和 DLQI(69.0%)与基线相比,降低比例较高。达到 EASI75 和 90 的患者比例分别为 90.2%和 53.7%。POEM 和 DLQI 与临床测量结果具有高度相关性。在影响 EASI90 达成的因素分析中,女性(OR2.5)、嗜酸性粒细胞增多症(OR0.2)和升高的 LDH(OR0.07)与 EASI90 显著相关。最常见的不良反应包括面部红斑(19.2%)和结膜炎(17.2%),均为轻度/中度,在治疗过程中缓解。总之,度普利尤单抗治疗中重度 AD 韩国患者 52 周证实了其长期疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9e6/8651808/18889dedbcaf/41598_2021_2950_Fig1_HTML.jpg

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