Background

Data for the effect of metabolic syndrome (MetS) on the efficacy and safety of biologic agents for psoriasis treatment are limited.

Objective

To evaluate long-term tildrakizumab efficacy, drug survival, and safety in patients with psoriasis by baseline MetS status.

Methods

Post hoc analyses of up to 3 years of efficacy data and 5 years of safety data from the phase 3, double-blind, randomized controlled reSURFACE 1 and 2 trial (NCT01722331 and NCT01729754) base and extension studies were conducted for patients receiving continuous tildrakizumab 100 or 200 mg.

Results

Of 338 (n = 124/214 in reSURFACE 1/2) and 307 (n = 147/160 in reSURFACE 1/2) patients continuously receiving tildrakizumab 100 and 200 mg, respectively, throughout the studies, 26/44 (21%/21%) and 34/30 (23%/19%) met MetS criteria. Proportions of patients who achieved a 75% improvement in the Psoriasis Area and Severity Index (PASI) in reSURFACE 1/2 were generally comparable among those with versus without MetS at week 52 (tildrakizumab 100 mg, 85%/86% vs 86%/94%; tildrakizumab 200 mg, 76%/87% vs 76%/87%) and through week 148. Results were similar for responders with 90% and 100% improvement in the PASI. Tildrakizumab's safety profile did not vary by MetS status.

Limitations

Small sample size and post hoc analysis limit interpretation.

Conclusion

Long-term tildrakizumab efficacy and safety were comparable between patients with and without MetS.

中文翻译：

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Tildrakizumab 的疗效、药物存活率和安全性在伴有和不伴有代谢综合征的银屑病患者中相当：来自两项 3 期随机对照研究（reSURFACE 1 和 reSURFACE 2）的长期结果。

背景

代谢综合征 (MetS) 对生物制剂治疗银屑病的疗效和安全性影响的数据有限。

客观的

通过基线 MetS 状态评估银屑病患者的长期 tildrakizumab 疗效、药物存活率和安全性。

方法

对连续接受 tildrakizumab 100 的患者进行了 3 期、双盲、随机对照 reSURFACE 1 和 2 试验（NCT01722331 和 NCT01729754）基础和扩展研究的长达 3 年疗效数据和 5 年安全性数据的事后分析或 200 毫克。

结果

在 338 名（reSURFACE 1/2 中 n = 124/214）和 307 名（reSURFACE 1/2 中 n = 147/160）患者中，在整个研究过程中分别持续接受 tildrakizumab 100 和 200 mg，26/44 (21%/ 21%) 和 34/30 (23%/19%) 符合 MetS 标准。在第 52 周时，在 reSURFACE 1/2 中银屑病面积和严重程度指数 (PASI) 改善 75% 的患者比例在有与无 MetS 的患者中大致相当（tildrakizumab 100 mg，85%/86% 与 86%/ 94%；tildrakizumab 200 mg，76%/87% 与 76%/87%）直到第 148 周。响应者的结果相似，PASI 改善 90% 和 100%。Tildrakizumab 的安全性不会因 MetS 状态而异。

限制

小样本量和事后分析限制了解释。

结论

有和没有 MetS 的患者的长期 tildrakizumab 疗效和安全性相当。