Dataset related to article "Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis) "

This record contains raw data related to article “Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis)" Abstract <strong>Background: </strong> Tildrakizumab is a humanized monoclonal antibody that binds selectively the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis. <strong>Objectives: </strong> We conducted a 52-week retrospective study to assess the effectiveness and safety of tildrakizumab in a real-life setting. <strong>Methods: </strong> Our retrospective study included 237 consecutive adults with moderate-to-severe plaque psoriasis, enrolled in 10 different Italian centres, treated with tildrakizumab up to Week 52. Patient characteristics, comorbidities, previous treatments and the PASI (Psoriasis Area and Severity Index) score at each visit (baseline, Week 16, Week 28 and Week 52) were retrieved from the electronic medical records. The percentages of patients achieving 75%, 90% and 100% (PASI 75, PASI 90 and PASI 100) improvement in PASI with respect to baseline PASI were registered. <strong>Results: </strong> At Week 52, 90.91%, 73.55% and 58.68% of patients achieved a PASI reduction ≥75% (PASI 75), PASI 90 and PASI 100, respectively. An absolute PASI ≤ 2 was reached by 85.95% at Week 52. Compared with Phase 3 clinical trials, we observed similar rates of PASI 75/90 responses and higher percentages of patients achieving PASI 100. Patients who had not responded to previous biologic treatments and patients with cardio-metabolic comorbidities were significantly more likely to achieve PASI 100 at Week 28 and PASI 90 at Week 52. The higher body mass index did not interfere with the odds of reaching PASI 75/90/100 at each time point. No significant safety findings were recorded throughout the study, and none of the patients had to interrupt the treatment because of adverse events. <strong>Conclusion: </strong> Our data suggest that the efficacy of tildrakizumab for plaque psoriasis in 'real-life' clinical practice is comparable with Phase 3 clinical trials with higher percentages of patients achieving complete skin clearance (PASI 100) at Weeks 16, 28 and 52.本数据集包含与论文《替达珠单抗（tildrakizumab）治疗慢性斑块状银屑病的真实世界疗效：一项为期52周的多中心回顾性研究——IL PSO（意大利银屑病全景研究）》摘要相关的原始数据。 **背景：** 替达珠单抗（tildrakizumab）是一种可选择性结合白细胞介素-23（interleukin-23, IL-23）p19亚基的人源化单克隆抗体，已被批准用于治疗中重度慢性斑块状银屑病。 **目的：** 本研究开展一项为期52周的回顾性研究，旨在评估替达珠单抗在真实世界临床场景中的疗效与安全性。 **方法：** 本回顾性研究共纳入来自意大利10家不同中心的237例连续入组的中重度斑块状银屑病成人患者，所有患者均接受替达珠单抗治疗直至第52周。研究人员从电子病历中提取了患者的基线特征、合并症情况、既往治疗史，以及每次随访（基线、第16周、第28周及第52周）时的银屑病面积与严重性指数（Psoriasis Area and Severity Index, PASI）评分。同时记录了相较于基线PASI评分，患者实现PASI评分改善75%、90%、100%（即PASI 75、PASI 90、PASI 100）的比例。 **结果：** 至第52周时，分别有90.91%、73.55%及58.68%的患者实现PASI评分降低≥75%（PASI 75）、PASI 90及PASI 100。至第52周时，85.95%的患者达到绝对PASI评分≤2。与III期临床试验（Phase 3 clinical trials）相比，本研究中患者的PASI 75/90应答率相似，但实现PASI 100的患者比例更高。既往生物制剂治疗应答不佳的患者，以及合并心血管代谢合并症的患者，在第28周时实现PASI 100、第52周时实现PASI 90的概率显著更高。较高的体重指数（body mass index, BMI）未对各时间点实现PASI 75/90/100的概率产生显著影响。整个研究期间未记录到显著的安全性相关事件，亦无患者因不良事件（adverse events）终止治疗。 **结论：** 本研究数据表明，替达珠单抗在“真实世界”临床实践中治疗斑块状银屑病的疗效与III期临床试验相当，且在第16、28及52周时，实现完全皮肤清除（PASI 100）的患者比例更高。