Real-World Effectiveness and Safety of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis: A 16-Week Study in Japan.

Teppei Hagino, Akihiko Uchiyama, Marina Onda, Keiji Kosaka, Takeshi Araki, Sei-Ichiro Motegi, Hidehisa Saeki, Eita Fujimoto, Naoko Kanda
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Abstract

Background: Real-world data on the effectiveness and safety of lebrikizumab for atopic dermatitis (AD) are limited.Objective: To evaluate the real-world effectiveness and safety of lebrikizumab on Japanese patients with AD.Methods: This two-center study included 126 Japanese patients with moderate-to-severe AD treated with lebrikizumab plus topical corticosteroids for 16 weeks. Eczema area and severity index (EASI), investigator's global assessment (IGA), peak-pruritus (PP)-numerical rating scale (NRS), sleep quality NRS, AD control tool (ADCT), dermatology life quality index (DLQI), patient-oriented eczema measure (POEM), immunoglobulin E (IgE), thymus and activation-regulated chemokine (TARC), lactate dehydrogenase (LDH), and total eosinophil count (TEC) were assessed during the treatment.Results: Lebrikizumab reduced all clinical indexes at week 4, which was maintained until week 16. The achievement rates of EASI 50, 75, 90, 100, and IGA 0/1 at week 16 were 83.1%, 57.1%, 27.3%, 11.7%, and 33.3%, respectively. The achievement rates of ≥4-point reduction in PP-NRS, sleep quality NRS, or DLQI, ADCT <7-point, and POEM ≤7-point at week 16 were 75.9%, 68.8%, 65.9%, 76.9%, and 80.4%, respectively. IgE, TARC, and LDH decreased while TEC increased during the treatment. No new safety concerns were observed.Conclusion: The 16-week treatment with lebrikizumab generated favorable effectiveness and safety in Japanese AD patients in real-world practice.

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Lebrikizumab治疗中重度特应性皮炎的有效性和安全性:一项在日本进行的为期16周的研究
背景:有关来曲珠单抗治疗特应性皮炎(AD)的有效性和安全性的真实世界数据十分有限。目的: 评估来曲珠单抗对日本特应性皮炎患者的实际有效性和安全性:评估来曲珠单抗对日本特应性皮炎患者的实际有效性和安全性。方法:在两个中心进行研究:这项由两个中心开展的研究纳入了126名中度至重度特应性皮炎日本患者,他们接受了为期16周的来布利珠单抗加局部皮质类固醇激素治疗。湿疹面积和严重程度指数(EASI)、研究者总体评估(IGA)、瘙痒峰值(PP)-数字评分量表(NRS)、睡眠质量NRS、AD控制工具(ADCT)、皮肤科生活质量指数(DLQI)、在治疗期间,还对免疫球蛋白 E (IgE)、胸腺和活化调节趋化因子 (TARC)、乳酸脱氢酶 (LDH) 和嗜酸性粒细胞总数 (TEC) 进行了评估。结果显示利珠单抗在第4周降低了所有临床指标,并一直维持到第16周。第16周EASI 50、75、90、100和IGA 0/1的达标率分别为83.1%、57.1%、27.3%、11.7%和33.3%。PP-NRS、睡眠质量NRS或DLQI、ADCT的≥4点降低率 结论:利巴韦林治疗16周的疗效显著:在实际治疗中,日本AD患者接受16周的来布利珠单抗治疗具有良好的有效性和安全性。
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