Abstract：
BACKGROUND: PERSIST was a prospective, non-interventional, long-term, German multicentre study of patients with moderate-to-severe psoriasis receiving guselkumab, an approved monoclonal antibody that binds to the p19 subunit of interleukin (IL)-23, in a real-world setting.
OBJECTIVE: Evaluation of the efficacy and safety of guselkumab, and its effect on health-related quality of life (HRQoL), in patients with moderate-to-severe psoriasis who have received 52 weeks of treatment.
METHODS: Patients (≥18 years old) were prescribed guselkumab as per routine clinical practice. End points assessed include Psoriasis Area and Severity Index (PASI), Physician\'s Global Assessment (PGA), target Nail Psoriasis Severity Index (NAPSI), and the Dermatology Life Quality Index (DLQI).
RESULTS: Overall, 303 patients were enrolled and treated with guselkumab. Mean disease duration was 21.0 years, and 77.2% and 51.2% of patients had received ≥1 prior conventional systemic or ≥1 prior biologic therapy, respectively. Mean PASI score decreased from 16.4 at baseline to 3.0 by Week (W) 28, and further decreased to 2.4 by W52, while the proportion of patients achieving an absolute PASI score of ≤1 increased from 1.3% at baseline, to 50.8% at W28 and to 58.4% by W52. PASI90 and PASI100 responses also showed marked improvements between W28 and W52, regardless of biologic treatment history. Clearance of psoriatic skin was observed in difficult-to-treat areas, with the percentage of patients achieving a PGA score ≤1 increasing between W28 and W52. Guselkumab improved HRQoL; mean DLQI score decreased from 13.7 at baseline to 2.8 by W28, and further decreased to 2.4 by W52. At W52, 64.6% of patients achieved a DLQI score ≤1. The cumulative probability of drug survival was 92.4% at W52.
CONCLUSIONS: Guselkumab is efficacious and well tolerated regardless of previous biologic therapies, comorbidities or psoriasis manifestation in difficult-to-treat areas. No new safety signals were observed.
OBJECTIVE: Evaluation of the efficacy and safety of guselkumab, and its effect on health-related quality of life (HRQoL), in patients with moderate-to-severe psoriasis who have received 52 weeks of treatment.
METHODS: Patients (≥18 years old) were prescribed guselkumab as per routine clinical practice. End points assessed include Psoriasis Area and Severity Index (PASI), Physician\'s Global Assessment (PGA), target Nail Psoriasis Severity Index (NAPSI), and the Dermatology Life Quality Index (DLQI).
RESULTS: Overall, 303 patients were enrolled and treated with guselkumab. Mean disease duration was 21.0 years, and 77.2% and 51.2% of patients had received ≥1 prior conventional systemic or ≥1 prior biologic therapy, respectively. Mean PASI score decreased from 16.4 at baseline to 3.0 by Week (W) 28, and further decreased to 2.4 by W52, while the proportion of patients achieving an absolute PASI score of ≤1 increased from 1.3% at baseline, to 50.8% at W28 and to 58.4% by W52. PASI90 and PASI100 responses also showed marked improvements between W28 and W52, regardless of biologic treatment history. Clearance of psoriatic skin was observed in difficult-to-treat areas, with the percentage of patients achieving a PGA score ≤1 increasing between W28 and W52. Guselkumab improved HRQoL; mean DLQI score decreased from 13.7 at baseline to 2.8 by W28, and further decreased to 2.4 by W52. At W52, 64.6% of patients achieved a DLQI score ≤1. The cumulative probability of drug survival was 92.4% at W52.
CONCLUSIONS: Guselkumab is efficacious and well tolerated regardless of previous biologic therapies, comorbidities or psoriasis manifestation in difficult-to-treat areas. No new safety signals were observed.
摘要：
背景：PERSIST是一个前瞻性的，非干预性，长期的,德国对接受guselkumab的中度至重度银屑病患者的多中心研究，一种已批准的单克隆抗体，在现实世界中与白介素（IL）-23的p19亚基结合。
目的：评估guselkumab的疗效和安全性，及其对健康相关生活质量（HRQoL）的影响，在接受52周治疗的中重度银屑病患者中。
方法：患者（≥18岁）按照常规临床实践服用guselkumab。评估的终点包括牛皮癣面积和严重程度指数(PASI)，医师全球评估（PGA），目标指甲银屑病严重程度指数（NAPSI），和皮肤病生活质量指数(DLQI)。
结果：总体而言，303例患者被纳入并接受guselkumab治疗。平均病程为21.0年，77.2%和51.2%的患者接受了≥1次常规全身治疗或≥1次生物治疗，分别。到第28周，平均PASI评分从基线时的16.4降至3.0，到W52时进一步降至2.4，而达到绝对PASI评分≤1的患者比例从基线时的1.3%增加，在W28降至50.8%，在W52降至58.4%。PASI90和PASI100反应也显示出W28和W52之间的显著改善,无论生物治疗史如何。在难以治疗的区域观察到牛皮癣皮肤的清除，在W28和W52之间，PGA评分≤1的患者百分比增加。Guselkumab改善了HRQoL；平均DLQI评分从基线时的13.7下降到W28的2.8，进一步下降到W52的2.4。在W52时，64.6%的患者达到DLQI评分≤1。W52时药物存活的累积概率为92.4%。
结论：无论以前的生物治疗，Guselkumab均有效且耐受性良好，在难以治疗的地区合并症或牛皮癣表现。没有观察到新的安全信号。
目的：评估guselkumab的疗效和安全性，及其对健康相关生活质量（HRQoL）的影响，在接受52周治疗的中重度银屑病患者中。
方法：患者（≥18岁）按照常规临床实践服用guselkumab。评估的终点包括牛皮癣面积和严重程度指数(PASI)，医师全球评估（PGA），目标指甲银屑病严重程度指数（NAPSI），和皮肤病生活质量指数(DLQI)。
结果：总体而言，303例患者被纳入并接受guselkumab治疗。平均病程为21.0年，77.2%和51.2%的患者接受了≥1次常规全身治疗或≥1次生物治疗，分别。到第28周，平均PASI评分从基线时的16.4降至3.0，到W52时进一步降至2.4，而达到绝对PASI评分≤1的患者比例从基线时的1.3%增加，在W28降至50.8%，在W52降至58.4%。PASI90和PASI100反应也显示出W28和W52之间的显著改善,无论生物治疗史如何。在难以治疗的区域观察到牛皮癣皮肤的清除，在W28和W52之间，PGA评分≤1的患者百分比增加。Guselkumab改善了HRQoL；平均DLQI评分从基线时的13.7下降到W28的2.8，进一步下降到W52的2.4。在W52时，64.6%的患者达到DLQI评分≤1。W52时药物存活的累积概率为92.4%。
结论：无论以前的生物治疗，Guselkumab均有效且耐受性良好，在难以治疗的地区合并症或牛皮癣表现。没有观察到新的安全信号。
