替西罗莫司真实世界疗效和安全性：64 周中度至重度斑块状银屑病患者研究。

Tildrakizumab Real-World Effectiveness and Safety Over 64 Weeks in Patients With Moderate-to-Severe Plaque Psoriasis.

出版信息

J Drugs Dermatol. 2024 Aug 1;23(8):612-618. doi: 10.36849/JDD.8217.

Abstract

BACKGROUND

Tildrakizumab is a humanized anti-interleukin-23 p19 monoclonal antibody approved for the treatment of moderate-to-severe plaque psoriasis. This report describes real-world effectiveness and safety of tildrakizumab through 64 weeks of treatment.

METHODS

In this Phase 4, multicenter, uncontrolled, open-label trial (NCT03718299), adults with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg at weeks 0 and 4 and every 12 weeks thereafter through week 52. Effectiveness was assessed from body surface area (BSA) affected and static Physician Global Assessment (sPGA) through week 64 and Psoriasis Area and Severity Index (PASI) through week 52. Adverse events are reported.

RESULTS

Of 55 patients enrolled, 45 completed the study and 36 received all doses of tildrakizumab. From baseline to week 64, mean +/- standard deviation BSA decreased by 83.1% (from 14.5 +/- 11.5 to 2.1 +/- 3.6) and sPGA by 67.6% (from 3.2 +/- 0.6 to 1.0 +/- 1.0); sPGA x BSA decreased by 89.6% (from 47.0 +/- 41.5 to 4.6 +/- 9.4; all P<0.001). PASI scores decreased compared to baseline at weeks 4, 16, 28, and 52 (P<0.001). For PASI responses at week 52 compared with baseline, 87.0% achieved greater than or equal to 75% improvement, 56.5% achieved greater than or equal to 90% improvement, and 32.6% achieved 100% improvement. Of 85 treatment-emergent adverse events in 34/55 patients, none were considered related to tildrakizumab treatment.

CONCLUSIONS

Tildrakizumab treatment was effective in adult patients with moderate-to-severe plaque psoriasis in real-world settings, with no new safety signals. J Drugs Dermatol. 2024;23(8):612-618. doi:10.36849/JDD.8217.

摘要

背景

替度鲁单抗是一种人源化抗白细胞介素-23p19 单克隆抗体，已被批准用于治疗中度至重度斑块型银屑病。本报告描述了替度鲁单抗在 64 周治疗期间的真实世界疗效和安全性。

方法

在这项 4 期、多中心、非对照、开放标签试验（NCT03718299）中，中重度斑块型银屑病成人患者在第 0 周和第 4 周接受替度鲁单抗 100mg，并在第 52 周后每 12 周接受一次治疗。在第 64 周评估体表面积（BSA）受影响和静态医师整体评估（sPGA），在第 52 周评估银屑病面积和严重程度指数（PASI）。报告不良事件。

结果

在 55 名入组患者中，45 名患者完成了研究，36 名患者接受了替度鲁单抗的所有剂量。从基线到第 64 周，BSA 的平均（±标准差）下降了 83.1%（从 14.5（±11.5）至 2.1（±3.6）），sPGA 下降了 67.6%（从 3.2（±0.6）至 1.0（±1.0））；sPGA x BSA 下降了 89.6%（从 47.0（±41.5）至 4.6（±9.4）；所有 P 值均<0.001）。与基线相比，PASI 评分在第 4、16、28 和 52 周时均有所下降（P 值均<0.001）。与基线相比，第 52 周时 PASI 应答的患者中，87.0%达到了大于或等于 75%的改善，56.5%达到了大于或等于 90%的改善，32.6%达到了 100%的改善。在 34/55 名患者的 85 例治疗出现的不良事件中，无 1 例被认为与替度鲁单抗治疗相关。