OBJECTIVE: Soon after tildrakizumab, an interleukin 23p19-inhibitor, was registered for moderate-to-severe plaque psoriasis, a prospective single-center cohort study was established to evaluate efficacy and safety of tildrakizumab in daily practice.
METHODS: Following approval of tildrakizumab, patients with moderate-to-severe plaque psoriasis eligible for systemic treatment were included into the Kiel Tildra Cohort (KTC) and followed using routine assessments of efficacy, psoriasis area and severity index (PASI), body surface area (BSA), dermatology life quality index (DLQI), itch (visual analog scale), and safety. Data of the KTC were compared to the respective phase 3 clinical trials.
RESULTS: The KTC included 150 patients differing substantially from those in the trial program. There was a high rate of previous systemic (87.3%) and biologic (31.8%) therapy and of comorbidity in the KTC as compared to the phase 3 studies. Due to the best practice approach, baseline PASI was lower in the KTC, but DLQI was similar in both groups. At the time of this analysis, 126 patients completed week 28, 92 patients week 52, and 58 patients week 76, respectively. There was a constant improvement in PASI, BSA, DLQI, and itch from baseline until week 76. There was no clinically meaningful laboratory abnormality.
CONCLUSIONS: Patients treated in routine practice with tildrakizumab differed substantially from the phase 3 studies. Despite systemic pre-treatment and increased comorbidity, tildrakizumab showed comparable efficacy and safety in the KTC. Prospective cohort studies are a suitable tool to generate RWE before registry data become available.
目标:tildrakizumab后不久,白细胞介素23p19抑制剂,被登记为中度至重度斑块状牛皮癣,我们建立了一项前瞻性单中心队列研究,目的是在日常实践中评估tildrakizumab的疗效和安全性.
方法:在批准tildrakizumab后,符合全身治疗条件的中度至重度斑块型银屑病患者被纳入KielTildra队列(KTC),并使用常规疗效评估进行随访,银屑病面积和严重程度指数(PASI),体表面积(BSA),皮肤病学生活质量指数(DLQI),痒(视觉模拟量表),和安全。将KTC的数据与相应的3期临床试验进行比较。
结果:KTC纳入了150名与试验项目有很大差异的患者。与3期研究相比,KTC先前的全身性(87.3%)和生物学(31.8%)治疗以及合并症的发生率很高。由于最佳实践方法,基线PASI在KTC中较低,但两组的DLQI相似。在这个分析的时候,126名患者完成第28周,92名患者完成第52周,58名患者完成第76周。PASI的不断改进,BSA,DLQI,从基线开始痒直到第76周。没有有临床意义的实验室异常。
结论:常规治疗中使用tildrakizumab的患者与3期研究有很大不同。尽管全身预处理和合并症增加,tildrakizumab在KTC中显示出相当的疗效和安全性.前瞻性队列研究是在注册数据可用之前生成RWE的合适工具。