Abstract：
BACKGROUND: 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.
OBJECTIVE: To assess the effectiveness and safety of guselkumab in treating moderate-severe HS under clinical practice conditions.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: To assess the effectiveness and safety of guselkumab in treating moderate-severe HS under clinical practice conditions.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：化脓性汗腺炎（HS）是一种引起病变的慢性皮肤病，其中发现高水平的白介素（IL）-23和辅助性T细胞17。阿达木单抗仍然是唯一被批准的治疗方法。Guselkumab,一种针对细胞外IL-23的p19蛋白亚基的抗体被批准用于治疗中重度银屑病，但关于其治疗HS疗效的证据有限.
目的：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。
方法：在西班牙13家医院进行了一项多中心回顾性观察性研究，包括在同情使用计划（2020年3月至2022年3月）内接受guselkumab治疗的成年HS患者。数据涉及治疗开始时的患者人口统计学和临床特征（基线），患者报告的结果（疼痛数字评定量表[NPRS]和皮肤病生活质量指数[DLQI]），医师评分(国际化脓性汗腺炎严重程度评分系统[IHS4]，记录基线和治疗16、24和48周的HS身体总体评分[HS-PGA]和化脓性汗腺炎临床反应[HiSCR]）。
结果：共纳入69例患者。大多数（84.10％）患有严重的HS（HurleyIII），并且已被诊断超过十年（58.80％）。患者接受过多种非生物（平均3.56）或生物（平均1.78）治疗，在接受生物制剂治疗的患者中,近90%曾接受过阿达木单抗治疗.IHS4、HS-PGA、NPRS,从基线到guselkumab治疗48周观察到DLQI评分（均p<0.01）。在16周和24周时，58.33%和56.52%的患者实现了HiSCR，分别。总的来说,16名患者停止治疗，主要是由于无效（n=7）或功效丧失（n=3）。未观察到严重不良事件。
结论：我们的结果表明，guselkumab可能是对其他生物制剂无反应的严重HS患者的安全有效的治疗选择。
目的：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。
方法：在西班牙13家医院进行了一项多中心回顾性观察性研究，包括在同情使用计划（2020年3月至2022年3月）内接受guselkumab治疗的成年HS患者。数据涉及治疗开始时的患者人口统计学和临床特征（基线），患者报告的结果（疼痛数字评定量表[NPRS]和皮肤病生活质量指数[DLQI]），医师评分(国际化脓性汗腺炎严重程度评分系统[IHS4]，记录基线和治疗16、24和48周的HS身体总体评分[HS-PGA]和化脓性汗腺炎临床反应[HiSCR]）。
结果：共纳入69例患者。大多数（84.10％）患有严重的HS（HurleyIII），并且已被诊断超过十年（58.80％）。患者接受过多种非生物（平均3.56）或生物（平均1.78）治疗，在接受生物制剂治疗的患者中,近90%曾接受过阿达木单抗治疗.IHS4、HS-PGA、NPRS,从基线到guselkumab治疗48周观察到DLQI评分（均p<0.01）。在16周和24周时，58.33%和56.52%的患者实现了HiSCR，分别。总的来说,16名患者停止治疗，主要是由于无效（n=7）或功效丧失（n=3）。未观察到严重不良事件。
结论：我们的结果表明，guselkumab可能是对其他生物制剂无反应的严重HS患者的安全有效的治疗选择。
