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.
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：Tildrakizumab是一种人源化抗白细胞介素-23p19单克隆抗体，被批准用于治疗中度至重度斑块状银屑病。该报告描述了通过64周治疗的tildrakizumab的真实世界有效性和安全性。
方法：在此阶段4中，多中心，不受控制,开放标签试验(NCT03718299),患有中度至重度斑块状银屑病的成年人在第0周和第4周接受了tildrakizumab100mg,此后每12周接受一次,直至第52周.通过第64周的体表面积（BSA）和静态医师全球评估（sPGA）以及第52周的牛皮癣面积和严重程度指数（PASI）评估有效性。报告不良事件。
结果：在55名患者中，45人完成了研究，36人接受了所有剂量的tildrakizumab。从基线到第64周,平均值+/-标准偏差BSA下降83.1%(从14.5+/-11.5下降到2.1+/-3.6),sPGA下降67.6%(从3.2+/-0.6下降到1.0+/-1.0);sPGAxBSA下降89.6%(从47.0+/-41.5sp下降到4.6+/-0.001+/-&nbb9.4)。与基线相比，第4、16、28和52周的PASI评分降低(P<0.001)。与基线相比，第52周的PASI反应，87.0%实现大于或等于75%的改进，56.5%实现大于或等于90%的改进,32.6%实现了100%的改善。在34/55患者的85例治疗中出现的不良事件中，没有一个被认为与tildrakizumab治疗有关.
结论：Tildrakizumab治疗在现实世界中对患有中度至重度斑块状银屑病的成年患者有效，没有新的安全信号.J药物Dermatol.2024；23（8）：612-618。doi:10.36849/JDD.8217。
方法：在此阶段4中，多中心，不受控制,开放标签试验(NCT03718299),患有中度至重度斑块状银屑病的成年人在第0周和第4周接受了tildrakizumab100mg,此后每12周接受一次,直至第52周.通过第64周的体表面积（BSA）和静态医师全球评估（sPGA）以及第52周的牛皮癣面积和严重程度指数（PASI）评估有效性。报告不良事件。
结果：在55名患者中，45人完成了研究，36人接受了所有剂量的tildrakizumab。从基线到第64周,平均值+/-标准偏差BSA下降83.1%(从14.5+/-11.5下降到2.1+/-3.6),sPGA下降67.6%(从3.2+/-0.6下降到1.0+/-1.0);sPGAxBSA下降89.6%(从47.0+/-41.5sp下降到4.6+/-0.001+/-&nbb9.4)。与基线相比，第4、16、28和52周的PASI评分降低(P<0.001)。与基线相比，第52周的PASI反应，87.0%实现大于或等于75%的改进，56.5%实现大于或等于90%的改进,32.6%实现了100%的改善。在34/55患者的85例治疗中出现的不良事件中，没有一个被认为与tildrakizumab治疗有关.
结论：Tildrakizumab治疗在现实世界中对患有中度至重度斑块状银屑病的成年患者有效，没有新的安全信号.J药物Dermatol.2024；23（8）：612-618。doi:10.36849/JDD.8217。
