Department of Dermatology, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid, Spain.
Department of Dermatology, Hospital Rio Hortega, Valladolid, Spain.
Actas Dermosifiliogr. 2023 Oct;114(9):755-762. doi: 10.1016/j.ad.2023.06.013. Epub 2023 Jun 16.
Hidradenitis suppurativa (HS) is a chronic skin condition causing lesions in which high levels of interleukin (IL)-23 and T-helper 17 cells are found. Adalimumab remains the only approved treatment. Guselkumab, an antibody targeting the p19 protein subunit of extracellular IL-23, is approved for the treatment of moderate-severe psoriasis, but evidence on its efficacy in treating HS is limited.
To assess the effectiveness and safety of guselkumab in treating moderate-severe HS under clinical practice conditions.
A multicentre retrospective observational study was carried out in 13 Spanish Hospitals including adult HS patients treated with guselkumab within a compassionate use programme (March 2020-March 2022). Data referred to patient demographic and clinical characteristics at treatment initiation (baseline), patient-reported outcomes (Numerical Pain Rating Scale [NPRS] and Dermatology Life Quality Index [DLQI]), physician scores (International Hidradenitis Suppurativa Severity Score System [IHS4], HS Physical Global Score [HS-PGA] and Hidradenitis Suppurativa Clinical Response [HiSCR]) were recorded at baseline and at 16, 24, and 48 weeks of treatment.
A total of 69 patients were included. Most (84.10%) had severe HS (Hurley III) and had been diagnosed for over ten years (58.80%). The patients had been subjected to multiple non-biological (mean 3.56) or biological (mean 1.78) therapies, and almost 90% of those treated with biologics had received adalimumab. A significant decrease in IHS4, HS-PGA, NPRS, and DLQI scores was observed from baseline to 48 weeks of guselkumab treatment (all p<0.01). HiSCR was achieved in 58.33% and 56.52% of the patients at 16 and 24 weeks, respectively. Overall, 16 patients discontinued treatment, mostly due to inefficacy (n=7) or loss of efficacy (n=3). No serious adverse events were observed.
Our results indicate that guselkumab may be a safe and effective therapeutic alternative for patients with severe HS that fail to respond to other biologics.
化脓性汗腺炎（HS）是一种慢性皮肤病，其病变中发现白细胞介素（IL）-23 和辅助性 T 细胞 17 水平升高。阿达木单抗仍然是唯一批准的治疗药物。 Guselkumab 是一种针对细胞外 IL-23 的 p19 蛋白亚单位的抗体，已被批准用于治疗中重度银屑病，但关于其在 HS 治疗中的疗效证据有限。
评估 Guselkumab 在临床实践条件下治疗中重度 HS 的有效性和安全性。
在 13 家西班牙医院进行了一项多中心回顾性观察性研究，该研究纳入了在同情使用计划（2020 年 3 月至 2022 年 3 月）中接受 Guselkumab 治疗的成年 HS 患者。数据涉及治疗开始时（基线）患者的人口统计学和临床特征、患者报告的结果（数字疼痛评分量表[NPRS]和皮肤病生活质量指数[DLQI]）、医生评分（国际化脓性汗腺炎严重程度评分系统[IHS4]、化脓性汗腺炎身体总体评分[HS-PGA]和化脓性汗腺炎临床反应[HiSCR]），这些评分在基线时以及治疗 16、24 和 48 周时进行记录。
共纳入 69 例患者。大多数（84.10%）为重度 HS（Hurley III 期），且诊断时间超过十年（58.80%）。患者曾接受过多种非生物制剂（平均 3.56 种）或生物制剂（平均 1.78 种）治疗，几乎 90%接受生物制剂治疗的患者曾接受过阿达木单抗治疗。从基线到 Guselkumab 治疗 48 周时，IHS4、HS-PGA、NPRS 和 DLQI 评分均显著下降（均 p<0.01）。分别有 58.33%和 56.52%的患者在 16 和 24 周时达到 HiSCR。总体而言，有 16 例患者因疗效不佳（n=7）或疗效丧失（n=3）而停止治疗。未观察到严重不良事件。
我们的结果表明，对于对其他生物制剂无反应的重度 HS 患者，Guselkumab 可能是一种安全有效的治疗选择。
