Abstract：
BACKGROUND: Certolizumab pegol (CZP) is an anti-tumor necrosis factor alpha (TNFα) approved for the treatment of moderate to severe plaque psoriasis (PSO). However, data on its real-world use is currently limited. The objective of this study was to describe the 1-year real-world effectiveness of CZP, its impact on health-related quality of life (HRQoL), and safety outcomes in patients with moderate to severe PSO in multi-country settings.
METHODS: CIMREAL, a prospective, noninterventional study, was conducted across Europe and Canada from August 2019 to December 2022. Patients were followed for 1-year, receiving CZP 400 mg initial doses at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg Q2W maintenance dosing. Effectiveness was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety was also evaluated.
RESULTS: Overall, 399 patients with moderate to severe PSO were included. Of these, 93.7% (374/399) and 77.9% (311/399) completed months 3 and 12, respectively. Mean age (± standard deviation) was 42.9 ± 13.5 years and body mass index was 28.5 ± 6.8 kg/m2, with the majority of patients being female (68.2%). At 12 months, CZP showed substantial effectiveness, achieving PASI 75 and PASI 90 response rates (≥ 75% and ≥ 90% improvement from baseline, respectively) of 77% and 56.5%, respectively. Patients with PASI score of ≤ 3 and ≤ 2 experienced improvement from 3 months (49.8% and 41.1%, respectively) to 12 months (82.0% and 75.3%, respectively). HRQoL considerably improved, with mean DLQI scores decreasing from 12.4 to 2.3 after 12 months of treatment, and the proportion of patients with DLQI 0/1 increased from 28.6% at 3 months to 59.4% at 12 months. The 1-year probability of persistence was approximately 85%. Overall, 30.6% of the patients experienced any adverse events and 9.3% had serious adverse events.
CONCLUSIONS: In routine clinical practice, CZP exhibited consistent effectiveness, positively impacting both skin psoriasis activity and HRQoL. The 1-year persistence of CZP was high, and no new safety signals were identified.
BACKGROUND: ClinicalTrials.gov Identifier: NCT04053881 https://www.
RESULTS: gov/study/NCT04053881 .
METHODS: CIMREAL, a prospective, noninterventional study, was conducted across Europe and Canada from August 2019 to December 2022. Patients were followed for 1-year, receiving CZP 400 mg initial doses at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg Q2W maintenance dosing. Effectiveness was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety was also evaluated.
RESULTS: Overall, 399 patients with moderate to severe PSO were included. Of these, 93.7% (374/399) and 77.9% (311/399) completed months 3 and 12, respectively. Mean age (± standard deviation) was 42.9 ± 13.5 years and body mass index was 28.5 ± 6.8 kg/m2, with the majority of patients being female (68.2%). At 12 months, CZP showed substantial effectiveness, achieving PASI 75 and PASI 90 response rates (≥ 75% and ≥ 90% improvement from baseline, respectively) of 77% and 56.5%, respectively. Patients with PASI score of ≤ 3 and ≤ 2 experienced improvement from 3 months (49.8% and 41.1%, respectively) to 12 months (82.0% and 75.3%, respectively). HRQoL considerably improved, with mean DLQI scores decreasing from 12.4 to 2.3 after 12 months of treatment, and the proportion of patients with DLQI 0/1 increased from 28.6% at 3 months to 59.4% at 12 months. The 1-year probability of persistence was approximately 85%. Overall, 30.6% of the patients experienced any adverse events and 9.3% had serious adverse events.
CONCLUSIONS: In routine clinical practice, CZP exhibited consistent effectiveness, positively impacting both skin psoriasis activity and HRQoL. The 1-year persistence of CZP was high, and no new safety signals were identified.
BACKGROUND: ClinicalTrials.gov Identifier: NCT04053881 https://www.
RESULTS: gov/study/NCT04053881 .
摘要：
背景：赛托珠单抗pegol（CZP）是一种抗肿瘤坏死因子α（TNFα），已被批准用于治疗中度至重度斑块状银屑病（PSO）。然而,其实际使用数据目前有限。这项研究的目的是描述CZP的1年真实世界有效性，它对健康相关生活质量（HRQoL）的影响，以及在多国家环境中中度至重度PSO患者的安全性结果。
方法：CIMREAL，一个潜在的，非干预性研究，于2019年8月至2022年12月在欧洲和加拿大进行。患者随访1年，在第0、2和4周接受CZP400mg初始剂量，然后每2周接受CZP200mg（Q2W）或CZP400mgQ2W维持剂量。使用银屑病面积和严重程度指数（PASI）和皮肤病生活质量指数（DLQI）评估有效性。还评估了安全性。
结果：总体而言，包括399例中度至重度PSO患者。其中,93.7%(374/399)和77.9%(311/399)分别完成第3个月和第12个月。平均年龄（±标准差）为42.9±13.5岁，体重指数为28.5±6.8kg/m2，大多数患者为女性（68.2％）。12个月时,CZP显示出实质性的有效性，达到PASI75和PASI90应答率(与基线相比改善≥75%和≥90%，分别为77%和56.5%，分别。PASI评分≤3和≤2的患者从3个月开始经历改善(49.8%和41.1%,分别)至12个月(82.0%和75.3%，分别)。HRQoL显著改善，治疗12个月后，平均DLQI评分从12.4降至2.3，DLQI0/1的患者比例从3个月时的28.6%增加到12个月时的59.4%。持续1年的概率约为85％。总的来说,30.6%的患者出现任何不良事件，9.3%的患者出现严重不良事件。
结论：在常规临床实践中，CZP表现出一致的有效性，积极影响皮肤银屑病活动和HRQoL。CZP的1年持久性很高，没有发现新的安全信号。
背景：ClinicalTrials.gov标识符：NCT04053881https://www.
结果：gov/study/NCT04053881。
方法：CIMREAL，一个潜在的，非干预性研究，于2019年8月至2022年12月在欧洲和加拿大进行。患者随访1年，在第0、2和4周接受CZP400mg初始剂量，然后每2周接受CZP200mg（Q2W）或CZP400mgQ2W维持剂量。使用银屑病面积和严重程度指数（PASI）和皮肤病生活质量指数（DLQI）评估有效性。还评估了安全性。
结果：总体而言，包括399例中度至重度PSO患者。其中,93.7%(374/399)和77.9%(311/399)分别完成第3个月和第12个月。平均年龄（±标准差）为42.9±13.5岁，体重指数为28.5±6.8kg/m2，大多数患者为女性（68.2％）。12个月时,CZP显示出实质性的有效性，达到PASI75和PASI90应答率(与基线相比改善≥75%和≥90%，分别为77%和56.5%，分别。PASI评分≤3和≤2的患者从3个月开始经历改善(49.8%和41.1%,分别)至12个月(82.0%和75.3%，分别)。HRQoL显著改善，治疗12个月后，平均DLQI评分从12.4降至2.3，DLQI0/1的患者比例从3个月时的28.6%增加到12个月时的59.4%。持续1年的概率约为85％。总的来说,30.6%的患者出现任何不良事件，9.3%的患者出现严重不良事件。
结论：在常规临床实践中，CZP表现出一致的有效性，积极影响皮肤银屑病活动和HRQoL。CZP的1年持久性很高，没有发现新的安全信号。
背景：ClinicalTrials.gov标识符：NCT04053881https://www.
结果：gov/study/NCT04053881。
