比美珠单抗对中重度化脓性汗腺炎患者报告结果的影响：来自BE HEARD i和ii的48周汇总结果

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-07-13 DOI:10.1007/s13555-025-01465-4

Vivian Y Shi, John R Ingram, Hadar Lev-Tov, Sylke Schneider-Burrus, Seth Forman, Martina L Porter, Koremasa Hayama, Linnea Thorlacius, Jérémy Lambert, Tom Vaux, Bartosz Lukowski, Robert L Rolleri, Jacek C Szepietowski

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引用次数: 0

摘要

化脓性汗腺炎（HS）症状（疼痛，瘙痒，气味和排水）影响生活质量（QoL）。Bimekizumab是一种人源化IgG1单克隆抗体，选择性抑制白细胞介素(IL)-17A和IL- 17f。bimekizumab对患者报告结果（PROs）的影响使用来自BE HEARD i和ii （BHI&II）研究的合并48周数据进行评估。方法：患者每2周接受（初始/维持）比美珠单抗320mg (Q2W)/Q2W、比美珠单抗Q2W/Q4W、比美珠单抗Q4W/Q4W或安慰剂/比美珠单抗Q2W。HS症状日记（HSSDD）和HS症状问卷（HSSQ）记录了HS特异性患者报告的症状；HS生活质量问卷（HiSQOL©）和皮肤病生活质量指数（DLQI）捕获健康相关生活质量（HRQoL）。从基线的变化（CfB）和达到临床有意义的改善阈值或低疾病影响的患者比例报告到第48周（观察病例）。结果：在1014名随机患者中，868名患者接受了比美珠单抗治疗，146名患者接受了安慰剂治疗。在第16周，比美珠单抗与安慰剂相比，观察到HSSDD/HSSQ评分的数值降低幅度更大。从第16周到第48周，连续使用比美珠单抗组的HSSQ评分进一步下降，安慰剂/比美珠单抗切换组的HSSQ评分显著下降。在第16周，比美珠单抗在HRQoL上比安慰剂有更大的改善（HiSQOL总评分平均CfB: - 11.7到- 10.3 vs - 5.5）。比美珠单抗治疗患者的HiSQOL反应率（总分降低21分）在第4周时数值上高于安慰剂（9.2%）（17.2-21.4%）；连续使用比美珠单抗组（42.0-47.4%）和切换组（55.0%）的比例在第48周增加。非常严重疾病影响的患者（HiSQOL总分≥24）随着使用比美珠单抗的时间而下降。在第16周，比美珠单抗与安慰剂相比，DLQI最小临床重要差异（降低4个点）在数值上更大（54.9-64.6% vs 49.1%）。成就增加到第48周，转换者达到了相似的比例（63.5-74.5% vs 76.5%）。DLQI评分为0/1（无HRQoL影响）的完成率也有类似的趋势。结论：比美珠单抗在第4周显示出临床意义上的改善，在中重度HS患者的pro中，HRQoL维持了1年以上。本文提供的图形摘要。试验注册：NCT04242446；NCT04242498。

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Bimekizumab Impact on Patient-Reported Outcomes in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II.

Introduction: Hidradenitis suppurativa (HS) symptoms (pain, itch, odour and drainage) impair quality of life (QoL). Bimekizumab, a humanised IgG1 monoclonal antibody, selectively inhibits interleukin (IL)-17A and IL-17F. The impact of bimekizumab on patient-reported outcomes (PROs) was assessed using pooled 48-week data from BE HEARD I&II (BHI&II) studies in moderate to severe HS.

Methods: Patients received (initial/maintenance) bimekizumab 320 mg every 2 weeks (Q2W)/Q2W, bimekizumab Q2W/Q4W, bimekizumab Q4W/Q4W or placebo/bimekizumab Q2W. HS Symptom Daily Diary (HSSDD) and HS Symptom Questionnaire (HSSQ) captured HS-specific patient-reported symptoms; HS Quality of Life questionnaire (HiSQOL^©) and Dermatology Life Quality Index (DLQI) captured health-related QoL (HRQoL). Change from baseline (CfB) and proportions of patients achieving clinically meaningful improvement thresholds or low disease impact are reported to Week 48 (observed case).

Results: Of 1014 randomised patients, 868 received bimekizumab and 146 placebo. Greater numerical reductions at Week 16 were observed across HSSDD/HSSQ scores with bimekizumab vs placebo. From Week 16 to 48, HSSQ scores further numerically reduced with continuous bimekizumab and substantially reduced for placebo/bimekizumab switchers. At Week 16, bimekizumab showed numerically greater improvement in HRQoL vs placebo (HiSQOL total score mean CfB: - 11.7 to - 10.3 vs - 5.5). HiSQOL response rate (21-point total score reduction) was numerically higher by Week 4 in bimekizumab-treated patients (17.2-21.4%) vs placebo (9.2%); rates increased to Week 48 with continuous bimekizumab (42.0-47.4%) and in switchers (55.0%). Patients with very severe disease impact (HiSQOL total score ≥ 24) decreased over time with bimekizumab. At Week 16, DLQI minimal clinically important difference (4-point decrease) achievement was numerically greater with bimekizumab vs placebo (54.9-64.6% vs 49.1%). Achievement increased to Week 48 and switchers attained similar proportions (63.5-74.5% vs 76.5%). Comparable trends were observed for DLQI score of 0/1 (no HRQoL impact) achievement rates.

Conclusion: Bimekizumab demonstrated clinically meaningful improvements by Week 4 in HRQoL, which were maintained over 1 year across PROs in patients with moderate to severe HS. Graphical Abstract available for this article.

Trial registration: NCT04242446; NCT04242498.

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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.