Stable Response and Sustained Improvement of Itch and Sleep Symptoms in Patients with Atopic Dermatitis Treated with Lebrikizumab over 52 Weeks.

IF 4.2 3区医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-08-01 Epub Date: 2024-07-13 DOI:10.1007/s13555-024-01225-w

Gil Yosipovitch, Peter Lio, Franz J Legat, Raj Chovatiya, Mette Deleuran, Evangeline Pierce, Marta Casillas, Yuxin Ding, Fan E Yang, Laia Bardolet, Sonja Ständer

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Abstract

Background: Lebrikizumab demonstrated significant improvement versus placebo for measures of skin clearance and patient-reported outcomes at weeks 16 and 52 in patients with moderate-to-severe atopic dermatitis (AD). We report the sustained impact of lebrikizumab monotherapy, over 52 weeks and between visits, on the frequency of itch and sleep loss symptoms, as assessed by Patient-Oriented Eczema Measure (POEM), in patients with moderate-to-severe AD.

Methods: In ADvocate1 and ADvocate2, Week-16 lebrikizumab responders (EASI75 or IGA 0/1 with ≥ 2-point improvement and without rescue medication) were randomized to lebrikizumab every 2 weeks (Q2W), every 4 weeks (Q4W), or placebo for 36 weeks. This pooled analysis reports improvement from Week 16 to 52 in patients achieving POEM response 0 (no days) or 1 (1-2 days) for Items 1 (itch) and 2 (sleep disturbance) for the lebrikizumab Q2W and Q4W treatment arms. Observed (excluding data collected after treatment discontinuation, rescue medication use, or patient transfer to escape arm) results were reported.

Results: At Week 16, for lebrikizumab Q2W and Q4W, 35.9% (n = 37/103) and 39.3% (n = 42/107) of patients responded 0 or 1 to Item 1 of POEM (Itch) and 12.6% (n = 13/103) and 12.1% (n = 13/107) responded 0. A total of 66.0% (n = 68/103) and 72.6% (n = 77/106) of patients responded 0 or 1 to Item 2 of POEM (Sleep) and 37.9% (n = 39/103) and 44.3% (n = 47/106) responded 0, respectively. By Week 52, for lebrikizumab Q2W and Q4W, 44.6% (n = 29/65) and 48.0% (n = 36/75) responded 0 or 1 to Item 1 of POEM (Itch), and 21.5% (n = 14/65) and 18.7% (n = 14/75) of patients responded 0. A total of 83.1% (n = 54/65) and 78.4% (n = 58/74) responded 0 or 1 to Item 2 of POEM (Sleep), and 67.7% (n = 44/65) and 59.5% (n = 44/74) responded 0, respectively.

Conclusion: Weekly POEM responses for itch and sleep disturbance remained stable between doses and visits, and continued to improve from Week 16 through 52, in lebrikizumab-treated patients, demonstrating consistent improvement over time for key AD symptoms.

Trial registration numbers: ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967).

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特应性皮炎患者使用莱布曲珠单抗治疗 52 周后瘙痒和睡眠症状得到稳定应答和持续改善

研究背景与安慰剂相比，在第16周和第52周，莱布利珠单抗可显著改善中重度特应性皮炎（AD）患者的皮肤清除率和患者报告结果。我们报告了利珠单抗单药治疗在52周内和两次就诊之间对中重度特应性皮炎患者瘙痒和失眠症状频率的持续影响（由患者导向湿疹测量法（POEM）评估）：在ADvocate1和ADvocate2中，第16周的来布利珠单抗应答者（EASI75或IGA 0/1且改善≥2分且未使用救治药物）被随机分配到每2周（Q2W）、每4周（Q4W）或安慰剂的来布利珠单抗治疗方案中，为期36周。本汇总分析报告了来布利珠单抗 Q2W 和 Q4W 治疗组患者在第 16 周至第 52 周期间对项目 1（瘙痒）和项目 2（睡眠障碍）的 POEM 反应为 0（无天数）或 1（1-2 天）的改善情况。报告的是观察结果（不包括治疗中止、使用抢救药物或患者转入逃避治疗组后收集的数据）：第16周时，对于来曲珠单抗Q2W和Q4W，35.9%（n = 37/103）和39.3%（n = 42/107）的患者对POEM第1项（痒）的反应为0或1，12.6%（n = 13/103）和12.1%（n = 13/107）的患者反应为0。分别有66.0%（n = 68/103）和72.6%（n = 77/106）的患者对POEM第2项（睡眠）回答为0或1，37.9%（n = 39/103）和44.3%（n = 47/106）的患者回答为0。到第52周，对于来曲珠单抗Q2W和Q4W，44.6%（n = 29/65）和48.0%（n = 36/75）的患者对POEM第1项（痒）的回答为0或1，21.5%（n = 14/65）和18.7%（n = 14/75）的患者回答为0。共有 83.1%（n = 54/65）和 78.4%（n = 58/74）的患者对 POEM 第 2 项（睡眠）的回答为 0 或 1，67.7%（n = 44/65）和 59.5%（n = 44/74）的患者回答为 0：结论：莱布利珠单抗治疗患者的瘙痒和睡眠障碍的每周POEM反应在不同剂量和访问之间保持稳定，并且从第16周到第52周持续改善，这表明随着时间的推移，AD主要症状的改善是一致的：试验注册号：ADvocate1（NCT04146363）和ADvocate2（NCT04178967）。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.