Puig L, Daudén E, Cuervas-Mons M, Novella C, Guisado C
Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Department of Dermatology, Instituto de Investigación Sanitaria (IIS-HP) Hospital Universitario de La Princesa, Madrid, Spain.
J Eur Acad Dermatol Venereol. 2025 Mar;39 Suppl 1:27-37. doi: 10.1111/jdv.19403. Epub 2023 Aug 24.
Guselkumab is a monoclonal antibody that blocks the IL-23 pathway with proven efficacy and tolerability in the treatment of moderate-to-severe plaque psoriasis.
To assess the persistence, effectiveness and safety of guselkumab in patients with moderate-to-severe psoriasis in real clinical practice in Spain.
SPRING was a Phase IV, retrospective and non-interventional study analysing patients with moderate-to-severe plaque psoriasis who had initiated guselkumab under clinical practice conditions at least 12 months before inclusion in the study. The primary endpoint was persistence (non-persistence: discontinuation or interruption ≥90 days). Effectiveness was assessed using the Psoriasis Area Severity Index (PASI) and Investigator Global Assessment (IGA). Dermatology Life Quality Index (DLQI) and safety were also evaluated.
A total of 284 patients were included between September 2020 and June 2021. The 1-year probability of persistence was 89.6% (86.1%-93.3%). The 1-year probability of persistence was also calculated according to prior biologic treatment, being 90.3% for biologic-naïve patients and 89.5% for patients who received one or more biologic therapies before guselkumab. Additionally, patients were also classified based on the frequency of the administration of guselkumab treatment; the 1-year probability of persistence was 91.9% in patients receiving guselkumab according to the Summary of Product Characteristics and 89.3% in patients with lengthened intervals of administration. After 1 year, PASI 90 was achieved by 56.4% of patients, IGA 0/1 response and BSA <3% were achieved by 65.5% and 77.8% of patients, respectively, and 65.8% achieved a minimal clinically significant difference (>4-point reduction) in the DLQI score at 1 year. Twenty-six adverse reactions (4 of them serious) were reported in 16 patients.
This study suggests that guselkumab has high persistence in real clinical practice in Spain, independently of the previous biologic treatments and changes in the frequency of treatment. Effectiveness and safety are consistent with previously published data.
古塞库单抗是一种单克隆抗体，可阻断白细胞介素-23通路，在治疗中度至重度斑块状银屑病方面具有已证实的疗效和耐受性。
评估古塞库单抗在西班牙实际临床实践中治疗中度至重度银屑病患者的持续性、有效性和安全性。
SPRING是一项IV期、回顾性和非干预性研究，分析在临床实践条件下至少在纳入研究前12个月开始使用古塞库单抗的中度至重度斑块状银屑病患者。主要终点是持续性（非持续性：停药或中断≥90天）。使用银屑病面积和严重程度指数（PASI）和研究者整体评估（IGA）评估有效性。还评估了皮肤病生活质量指数（DLQI）和安全性。
2020年9月至2021年6月期间共纳入284例患者。持续性的1年概率为89.6%（86.1%-93.3%）。还根据先前的生物治疗计算了持续性的1年概率，初治生物制剂患者为90.3%，在使用古塞库单抗之前接受过一种或多种生物治疗的患者为89.5%。此外，还根据古塞库单抗治疗给药频率对患者进行分类；根据产品特性摘要接受古塞库单抗治疗的患者持续性的1年概率为91.9%，给药间隔延长的患者为89.3%。1年后，56.4%的患者达到PASI 90，65.5%和77.8%的患者分别达到IGA 0/1反应和体表面积<3%，65.8%的患者在1年时DLQI评分达到最小临床显著差异（降低>4分）。16例患者报告了26例不良反应（其中4例严重）。
本研究表明，在西班牙的实际临床实践中，古塞库单抗具有较高的持续性，与先前的生物治疗和治疗频率变化无关。有效性和安全性与先前发表的数据一致。
