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日本真实世界实践中巴瑞替尼治疗中重度特应性皮炎的疗效和安全性。

Efficacy and safety of baricitinib treatment for moderate to severe atopic dermatitis in real-world practice in Japan.

机构信息

Department of Dermatology, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan.

Department of Dermatology, Nippon Medical School, Tokyo, Japan.

出版信息

J Dermatol. 2023 Jul;50(7):869-879. doi: 10.1111/1346-8138.16763. Epub 2023 Mar 8.

Abstract

The authors evaluated the efficacy and safety of baricitinib, a Janus kinase 1/2 inhibitor, for atopic dermatitis (AD) in real-world practice. From August 2021 to September 2022, 36 patients aged ≥15 years with moderate to severe AD were treated with oral baricitinib 4 mg/day plus topical corticosteroids. Baricitinib improved clinical indexes; the percent reduction at weeks 4 and 12 was a median of 69.19% and 69.98% for the Eczema Area and Severity Index (EASI), 84.52% and 76.33% for the Atopic Dermatitis Control Tool, and 76.39% and 64.58% for Peak Pruritus Numerical Rating Score, respectively. The achievement rate of EASI 75 was 38.89% and 33.33% at weeks 4 and 12, respectively. The percent reduction of EASI in the head and neck, upper limbs, lower limbs, and trunk was 56.9%, 68.3%, 80.7%, and 62.5% at week 12, respectively, with a significant difference between the head and neck versus the lower limbs. Baricitinib decreased thymus and activation-regulated chemokine, lactate dehydrogenase, and total eosinophil count at week 4. Baseline EASI of the head and neck negatively correlated with percent reduction of EASI at week 4, while baseline EASI of the lower limbs positively correlated with percent reduction of EASI at week 12. Treatment-emergent adverse events included elevation of creatine phosphokinase (11.1%), herpes labialis (5.6%), furuncle (8.3%), and exacerbation of AD (1%), without serious treatment-emergent adverse events. In this real-world study, baricitinib was well tolerated for patients with AD and achieved therapeutic effects comparable to those in clinical trials. High baseline EASI of the lower limbs might predict good treatment response at week 12, while high baseline EASI of the head and neck might predict poor treatment response at week 4 in baricitinib treatment for AD.

摘要

作者评估了 Janus 激酶 1/2 抑制剂巴瑞替尼治疗真实世界中特应性皮炎(AD)的疗效和安全性。2021 年 8 月至 2022 年 9 月,36 例年龄≥15 岁的中重度 AD 患者接受巴瑞替尼 4mg/天联合外用皮质类固醇治疗。巴瑞替尼改善了临床指标;第 4 周和第 12 周 Eczema Area and Severity Index(EASI)的中位下降率分别为 69.19%和 69.98%,Atopic Dermatitis Control Tool 的下降率分别为 84.52%和 76.33%,Peak Pruritus Numerical Rating Score 的下降率分别为 76.39%和 64.58%。第 4 周和第 12 周 EASI 75 达标率分别为 38.89%和 33.33%。第 12 周时,头颈部、上肢、下肢和躯干的 EASI 下降率分别为 56.9%、68.3%、80.7%和 62.5%,头颈部与下肢之间差异有统计学意义。巴瑞替尼在第 4 周时降低了胸腺和激活调节趋化因子、乳酸脱氢酶和总嗜酸性粒细胞计数。第 4 周时 EASI 的基线值与 EASI 的下降率呈负相关,而第 12 周时 EASI 的基线值与 EASI 的下降率呈正相关。治疗相关不良事件包括肌酸磷酸激酶升高(11.1%)、唇疱疹(5.6%)、疖(8.3%)和 AD 恶化(1%),但无严重的治疗相关不良事件。在这项真实世界研究中,巴瑞替尼治疗 AD 患者具有良好的耐受性,疗效与临床试验相当。下肢的 EASI 基线值较高可能预示着第 12 周的治疗反应良好,而头颈部的 EASI 基线值较高可能预示着第 4 周时的治疗反应不佳。

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