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.
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。