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
{"title":"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","authors":"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","doi":"10.1007/s13555-025-01521-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2000,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"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\",\"doi\":\"10.1007/s13555-025-01521-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":11186,\"journal\":{\"name\":\"Dermatology and Therapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2025-08-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatology and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s13555-025-01521-z\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01521-z","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
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.
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.
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.
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