Abstract：
OBJECTIVE: Risankizumab - a humanized monoclonal antibody that targets the p19 subunit of IL-23 - has been recently approved to treat moderate-to-severe plaque psoriasis. Real-world data based on a representative pool of patients are currently lacking.
OBJECTIVE: To assess the mid- and long-term safety and efficacy profile of risankizumab in patients with moderate-to-severe psoriasis in the routine clinical practice.
METHODS: This was a retrospective and multicenter study of consecutive psoriatic patients on risankizumab from April 2020 through November 2022. The primary endpoint was the number of patients who achieved a 100% improvement in their Psoriasis Area and Severity Index (PASI) (PASI100) on week 52.
RESULTS: A total of 510 patients, 198 (38.8%) women and 312 (61.2%) men were included in the study. The mean age was 51.7±14.4 years. A total of 227 (44.5%) study participants were obese (body mass index [BMI] >30kg/m2). The mean baseline PASI score was 11.4±7.2, and the rate of patients who achieved PASI100 on week 52, 67.0%. Throughout the study follow-up, 21%, 50.0%, 59.0%, and 66% of the patients achieved PASI100 on weeks 4, 16, 24, and 40, respectively. The number of patients who achieved a PASI ≤2 was greater in the group with a BMI ≤30kg/m2 on weeks 4 (P=.04), 16 (P=.001), and 52 (P=.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (P=.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (P=.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment.
CONCLUSIONS: Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.
OBJECTIVE: To assess the mid- and long-term safety and efficacy profile of risankizumab in patients with moderate-to-severe psoriasis in the routine clinical practice.
METHODS: This was a retrospective and multicenter study of consecutive psoriatic patients on risankizumab from April 2020 through November 2022. The primary endpoint was the number of patients who achieved a 100% improvement in their Psoriasis Area and Severity Index (PASI) (PASI100) on week 52.
RESULTS: A total of 510 patients, 198 (38.8%) women and 312 (61.2%) men were included in the study. The mean age was 51.7±14.4 years. A total of 227 (44.5%) study participants were obese (body mass index [BMI] >30kg/m2). The mean baseline PASI score was 11.4±7.2, and the rate of patients who achieved PASI100 on week 52, 67.0%. Throughout the study follow-up, 21%, 50.0%, 59.0%, and 66% of the patients achieved PASI100 on weeks 4, 16, 24, and 40, respectively. The number of patients who achieved a PASI ≤2 was greater in the group with a BMI ≤30kg/m2 on weeks 4 (P=.04), 16 (P=.001), and 52 (P=.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (P=.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (P=.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment.
CONCLUSIONS: Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.
摘要：
目的：risankizumab是一种针对IL-23p19亚基的人源化单克隆抗体，最近已被批准用于治疗中度至重度斑块状银屑病。目前缺乏基于代表性患者库的真实世界数据。
目的：评估常规临床实践中至重度银屑病患者利沙单抗的中长期安全性和有效性。
方法：这是一项对2020年4月至2022年11月期间连续接受利沙单抗治疗的银屑病患者的多中心回顾性研究。主要终点是在第52周时银屑病面积和严重程度指数（PASI）（PASI100）改善100％的患者人数。
结果：共有510名患者，研究包括198名（38.8%）女性和312名（61.2%）男性。平均年龄为51.7±14.4岁。共有227名（44.5%）研究参与者肥胖（体重指数[BMI]>30kg/m2）。平均基线PASI评分为11.4±7.2，第52周达到PASI100的患者率为67.0%。在整个研究随访过程中，21%,50.0%,59.0%,66%的患者分别在第4、16、24和40周获得PASI100。在第4周BMI≤30kg/m2的组中，达到PASI≤2的患者人数更多（P=.04），16(P=.001)，和52（P=0.002）。在第16周和第52周，未治疗组中达到PASI100的患者数量在统计学上显着增加（P=0.001，分别)。在第16周时，银屑病性关节病组中达到PASI100的参与者数量显着降低（P=.04）。在整个研究样本中，22例（4.3%）患者报告了某种类型的不良事件，20例（3.9%）患者停止治疗。
结论：Risankizumab在常规临床实践中被证明是中重度银屑病患者安全有效的治疗方法。
目的：评估常规临床实践中至重度银屑病患者利沙单抗的中长期安全性和有效性。
方法：这是一项对2020年4月至2022年11月期间连续接受利沙单抗治疗的银屑病患者的多中心回顾性研究。主要终点是在第52周时银屑病面积和严重程度指数（PASI）（PASI100）改善100％的患者人数。
结果：共有510名患者，研究包括198名（38.8%）女性和312名（61.2%）男性。平均年龄为51.7±14.4岁。共有227名（44.5%）研究参与者肥胖（体重指数[BMI]>30kg/m2）。平均基线PASI评分为11.4±7.2，第52周达到PASI100的患者率为67.0%。在整个研究随访过程中，21%,50.0%,59.0%,66%的患者分别在第4、16、24和40周获得PASI100。在第4周BMI≤30kg/m2的组中，达到PASI≤2的患者人数更多（P=.04），16(P=.001)，和52（P=0.002）。在第16周和第52周，未治疗组中达到PASI100的患者数量在统计学上显着增加（P=0.001，分别)。在第16周时，银屑病性关节病组中达到PASI100的参与者数量显着降低（P=.04）。在整个研究样本中，22例（4.3%）患者报告了某种类型的不良事件，20例（3.9%）患者停止治疗。
结论：Risankizumab在常规临床实践中被证明是中重度银屑病患者安全有效的治疗方法。
