Long-Term Effectiveness and Safety of Bimekizumab in Patients with Moderate to Severe Hidradenitis Suppurativa Under Real Clinical Practice Conditions: The Importance of Combined Treatment in Hurley III Patients and Potential Factors Associated with Complete Response.

IF 4.2 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-08-27 DOI:10.1007/s13555-025-01521-z

Miguel Mansilla-Polo, Carmen García-Moronta, Pablo Fernández-Crehuet, Patricia Garbayo-Salmons, Martí Pons-Benavent, Lucía Aguilar-González, David Jiménez-Gallo, Rebeca Alcalá-García, Gemma Martín-Ezquerra, Antonio Martorell, Laura Mahiques-Santos, Fernando Alfageme-Roldán, Begoña Escutia-Muñoz, Antonio Sahuquillo-Torralba, Rafael Fayos-Gregori, Alberto Soto-Moreno, Irene Sánchez-Gutiérrez, Rafael Botella-Estrada, Eva Vilarrasa, Alejandro Molina-Leyva

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引用次数: 0

Abstract

Introduction: Hidradenitis suppurativa (HS) is a debilitating, chronic inflammatory skin disease that severely impacts patients' quality of life. Bimekizumab, the first dual inhibitor of interleukin (IL)-17A and IL-17F, has shown efficacy in phase 3 clinical trials and is currently approved for moderate-to-severe HS. However, long-term data in real-world clinical settings are lacking.

Methods: This was a multicenter, retrospective observational study of 78 adult patients with moderate-to-severe HS treated with bimekizumab. Outcomes included International Hidradenitis Suppurativa Severity Score System (IHS4), IHS4-55/75/90/100 response, pain, flare frequency, and safety through week 48.

Results: The mean age was 48.5 years, 60.3% (47/78) were classified as Hurley stage III. At week 24, results for IHS4-55, IHS4-75, and IHS4-90 were 54.7% (29/53), 41.5% (22/53), and 3.8% (2/53), respectively. At week 24, results for IHS4-55, IHS4-75, and IHS4-90 were 67.9% (53/78), 30.7% (24/78), and2.5% (2/78), respectively. At week 48, 56 patients were included, of whom 82.1% (46/56) reached an IHS4-55 response, 62.5% (35/56) an IHS4-75, 32,1% (18/56) an IHS4-90, and 23.2% (13/56) a complete response (IHS4-100). Patients unavailable for analysis had either not yet reached follow-up, 72.7% (16/22), or had discontinued treatment, 27.2% (6/22). Combination therapy in any form was more frequent in Hurley III patients, who had similar efficacy compared to Hurley II patients in terms of IHS4-55 at week 48. Adverse events occurred in 43.6% (34/78) of patients, mostly mild to moderate fungal infections (26.9%, 21/78) and eczematous reactions (9%, 6/78). During follow-up, eight patients (10.3%) discontinued treatment, primarily as a result of lack of efficacy (6.4%, 5/78).

Conclusion: Bimekizumab shows sustained clinical effectiveness and a manageable safety profile for moderate-to-severe HS in real-world practice up to 48 weeks. In our setting, the combination of medical and surgical treatment is frequently used and may contribute to improved effectiveness, particularly in patients with extensive structural damage.

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在真实临床条件下，比美珠单抗治疗中重度化脓性汗腺炎的长期有效性和安全性：Hurley III型患者联合治疗的重要性和完全缓解相关的潜在因素

化脓性汗腺炎（HS）是一种使人衰弱的慢性炎症性皮肤病，严重影响患者的生活质量。Bimekizumab是首个白细胞介素(IL)-17A和IL- 17f的双重抑制剂，已在3期临床试验中显示出疗效，目前已被批准用于中重度HS。然而，缺乏现实世界临床环境的长期数据。方法：这是一项多中心、回顾性观察性研究，78例接受比美珠单抗治疗的中重度HS成年患者。结果包括国际化脓性汗腺炎严重程度评分系统（IHS4）、IHS4-55/75/90/100反应、疼痛、发作频率和48周的安全性。结果：平均年龄48.5岁，60.3%（47/78）为Hurley III期。在第24周，IHS4-55、IHS4-75和IHS4-90的结果分别为54.7%（29/53）、41.5%（22/53）和3.8%（2/53）。在第24周，IHS4-55、IHS4-75和IHS4-90的结果分别为67.9%（53/78）、30.7%（24/78）和2.5%（2/78）。在第48周，纳入56例患者，其中82.1%（46/56）达到IHS4-55缓解，62.5%（35/56）达到IHS4-75缓解，32,1%（18/56）达到IHS4-90缓解，23.2%（13/56）达到完全缓解（IHS4-100）。无法进行分析的患者要么尚未随访，占72.7%(16/22)，要么已停止治疗，占27.2%（6/22）。任何形式的联合治疗在Hurley III型患者中更为常见，在第48周时，与Hurley II型患者相比，其IHS4-55的疗效相似。43.6%（34/78）的患者发生不良反应，其中以轻中度真菌感染（26.9%,21/78）和湿疹反应（9%,6/78）居多。在随访期间，8名患者（10.3%）停止治疗，主要是因为缺乏疗效（6.4%,5/78）。结论：Bimekizumab在现实世界实践中显示出持续的临床有效性和可管理的安全性，可达48周。在我们的环境中，经常使用内科和外科相结合的治疗方法，这可能有助于提高疗效，特别是对于有广泛结构损伤的患者。

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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.