Grau-Pérez Mercè, Ciudad Cristina, Molina-Leyva Alejandro, Martorell Antonio, Vilarrasa Eva, Haselgruber Sofía, Pascual José Carlos, Alfageme Fernando, Albert Irene, Garcias-Ladaria Juan, Melgosa Francisco Javier, Rivera Raquel, Campos Minia, Ochando Gemma, García-Ruiz Ramón
Dermatology Department, Hospital Universitario Puerta de Hierro Majadahonda, IDIPHISA, Madrid, Spain.
Dermatology Department, Hospital Universitario Gregorio Marañón, Madrid, Spain.
Dermatology. 2025 Jun 30:1-7. doi: 10.1159/000546647.
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.
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.
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.
Adalimumab showed a similar safety profile in adolescents with moderate-to-severe HS as in adults, with better effectiveness data.
化脓性汗腺炎（HS）是一种慢性疾病，会导致皮肤出现疼痛性肿块和瘢痕。在相当数量的患者中，该病始于青春期。阿达木单抗是首个被批准用于青少年HS患者的生物药物，但其批准是基于从其他疾病进行的模型外推。目前缺乏关于阿达木单抗在该年龄组HS患者中的有效性和安全性的数据。我们的目的是描述阿达木单抗在中度至重度HS青少年患者中的有效性和安全性。
回顾性多中心病例系列研究。邀请西班牙各地的HS治疗单位参与，纳入所有在青春期开始使用阿达木单抗的患者。收集人口统计学、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。通过对副作用随时间的量化和描述来评估安全性。
共纳入来自9个HS治疗单位的65例患者。开始使用阿达木单抗时的平均年龄为15.5岁。共有76.9%的患者在6个月时达到HiSCR。7例患者出现副作用，其中3例需要停药，但均完全康复。更常使用成人剂量（每两周80mg/每周40mg）。阿达木单抗的中位药物存活时间为5.6年（第25百分位数：2.9年），推荐的青少年剂量（每两周40mg）与需要强化治疗相关（p<0.001）。本研究的主要局限性是缺乏对照组和回顾性设计。
阿达木单抗在中度至重度HS青少年患者中的安全性与成人相似，有效性数据更好。
