Mercè Grau-Pérez, Cristina Ciudad, Alejandro Molina-Leyva, Antonio Martorell, Eva Vilarrasa, Sofía Haselgruber, José Carlos Pascual, Fernando Alfageme, Irene Albert, Juan Garcias-Ladaria, Francisco Javier Melgosa, Raquel Rivera, Minia Campos, Gemma Ochando, Ramón García-Ruiz
{"title":"adolescent - hs:一个真实世界的多中心病例系列,关于阿达木单抗在患有中重度化脓性汗腺炎的青少年中的有效性和安全性。","authors":"Mercè Grau-Pérez, Cristina Ciudad, Alejandro Molina-Leyva, Antonio Martorell, Eva Vilarrasa, Sofía Haselgruber, José Carlos Pascual, Fernando Alfageme, Irene Albert, Juan Garcias-Ladaria, Francisco Javier Melgosa, Raquel Rivera, Minia Campos, Gemma Ochando, Ramón García-Ruiz","doi":"10.1159/000546647","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Hidradenitis suppurativa (HS) is a chronic disease that causes painful skin lumps and scarring in the skin. In an important number of patients, the disease starts in adolescence. Adalimumab was the first biologic drug approved in adolescents with HS, yet approval was done on a model-based extrapolation from other diseases. Data regarding the effectiveness and safety of adalimumab in HS in this age group is lacking. Our objective was to describe the effectiveness and safety of adalimumab in adolescents with moderate-to-severe HS.</p><p><strong>Methods: </strong>Retrospective multicenter case series. HS units across Spain were invited to participate, including all patients starting adalimumab in adolescence. Demographic, clinical, and treatment-related characteristics were retrieved. Effectiveness was measured as the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at 6 months. Safety was assessed by means of quantification and description of side effects over time.</p><p><strong>Results: </strong>A total of 65 patients from 9 HS units were included. Mean age at adalimumab start was 15.5 years. A total of 76.9% of patients achieved HiSCR at 6 months. Side effects were observed in 7 patients, 3 of them requiring drug discontinuation, with full recovery. The adult dosage (80 mg every other week [EOW]/40 mg every week) was more frequently used. The median drug survival time for adalimumab was 5.6 years (25th percentile: 2.9 years), and the recommended adolescent dosage (40 mg EOW) was associated with a need for intensification (p < 0.001). The main limitations of the study are the lack of a comparison group and the retrospective design.</p><p><strong>Conclusion: </strong>Adalimumab showed a similar safety profile in adolescents with moderate-to-severe HS as in adults, with better effectiveness data.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"1-7"},"PeriodicalIF":2.7000,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12503423/pdf/","citationCount":"0","resultStr":"{\"title\":\"ADOLESBIO-HS: A Real-World Multicenter Case Series on the Effectiveness and Safety of Adalimumab in Adolescents with Moderate-to-Severe Hidradenitis Suppurativa.\",\"authors\":\"Mercè Grau-Pérez, Cristina Ciudad, Alejandro Molina-Leyva, Antonio Martorell, Eva Vilarrasa, Sofía Haselgruber, José Carlos Pascual, Fernando Alfageme, Irene Albert, Juan Garcias-Ladaria, Francisco Javier Melgosa, Raquel Rivera, Minia Campos, Gemma Ochando, Ramón García-Ruiz\",\"doi\":\"10.1159/000546647\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Hidradenitis suppurativa (HS) is a chronic disease that causes painful skin lumps and scarring in the skin. 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Mean age at adalimumab start was 15.5 years. A total of 76.9% of patients achieved HiSCR at 6 months. Side effects were observed in 7 patients, 3 of them requiring drug discontinuation, with full recovery. The adult dosage (80 mg every other week [EOW]/40 mg every week) was more frequently used. The median drug survival time for adalimumab was 5.6 years (25th percentile: 2.9 years), and the recommended adolescent dosage (40 mg EOW) was associated with a need for intensification (p < 0.001). 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引用次数: 0
摘要
背景:化脓性汗腺炎(HS)是一种慢性疾病,引起疼痛的皮肤肿块和皮肤瘢痕。在相当数量的患者中,这种疾病始于青春期。阿达木单抗是第一个被批准用于青少年HS的生物药物,但批准是基于其他疾病的基于模型的推断。关于阿达木单抗在该年龄组HS中的有效性和安全性的数据缺乏。目的:评价阿达木单抗治疗青少年中重度HS的有效性和安全性。方法:回顾性多中心病例系列。西班牙各地的HS单位被邀请参与,包括所有在青春期开始使用阿达木单抗的患者。检索人口学、临床和治疗相关特征。有效性以6个月时达到化脓性汗腺炎临床缓解(HiSCR)的患者比例来衡量。安全性通过量化和描述副作用随时间的变化来评估。结果:纳入9个HS单位的65例患者。阿达木单抗开始的平均年龄为15.5岁。76.9%的患者在6个月时达到HiSCR。7例患者出现不良反应,其中3例需要停药,均完全康复。以成人剂量(EOW 80mg / EW 40mg)较多。阿达木单抗的中位药物生存时间为5.6年(第25个百分点:2.9年),推荐的青少年剂量(40mg EOW)与需要强化相关(局限性:缺乏对照组和回顾性设计)。结论:阿达木单抗在青少年中重度HS患者中表现出与成人相似的安全性,并且具有更好的有效性数据。
ADOLESBIO-HS: A Real-World Multicenter Case Series on the Effectiveness and Safety of Adalimumab in Adolescents with Moderate-to-Severe Hidradenitis Suppurativa.
Introduction: Hidradenitis suppurativa (HS) is a chronic disease that causes painful skin lumps and scarring in the skin. In an important number of patients, the disease starts in adolescence. Adalimumab was the first biologic drug approved in adolescents with HS, yet approval was done on a model-based extrapolation from other diseases. Data regarding the effectiveness and safety of adalimumab in HS in this age group is lacking. Our objective was to describe the effectiveness and safety of adalimumab in adolescents with moderate-to-severe HS.
Methods: Retrospective multicenter case series. HS units across Spain were invited to participate, including all patients starting adalimumab in adolescence. Demographic, clinical, and treatment-related characteristics were retrieved. Effectiveness was measured as the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at 6 months. Safety was assessed by means of quantification and description of side effects over time.
Results: A total of 65 patients from 9 HS units were included. Mean age at adalimumab start was 15.5 years. A total of 76.9% of patients achieved HiSCR at 6 months. Side effects were observed in 7 patients, 3 of them requiring drug discontinuation, with full recovery. The adult dosage (80 mg every other week [EOW]/40 mg every week) was more frequently used. The median drug survival time for adalimumab was 5.6 years (25th percentile: 2.9 years), and the recommended adolescent dosage (40 mg EOW) was associated with a need for intensification (p < 0.001). The main limitations of the study are the lack of a comparison group and the retrospective design.
Conclusion: Adalimumab showed a similar safety profile in adolescents with moderate-to-severe HS as in adults, with better effectiveness data.
期刊介绍:
Published since 1893, ''Dermatology'' provides a worldwide survey of clinical and investigative dermatology. Original papers report clinical and laboratory findings. In order to inform readers of the implications of recent research, editorials and reviews prepared by invited, internationally recognized scientists are regularly featured. In addition to original papers, the journal publishes rapid communications, short communications, and letters to ''Dermatology''. ''Dermatology'' answers the complete information needs of practitioners concerned with progress in research related to skin, clinical dermatology and therapy. The journal enjoys a high scientific reputation with a continually increasing impact factor and an equally high circulation.