Qiu Jingyue, Liu Jiakuo, Liu Wenwen, Lin Fei, Shi Ning
Pharmaceutical Department, PLA Strategic Support Force Medical Center, Beijing, China.
Shandong Provincial Center for ADR Monitoring, Jinan, China.
Front Med (Lausanne). 2023 Sep 29;10:1264667. doi: 10.3389/fmed.2023.1264667. eCollection 2023.
BACKGROUND: Orally effective therapeutics for plaque psoriasis with improved response rates, lower toxicity and costs are needed in clinical practices. This study aims to assess the efficacy and safety of the recently approved TYK2 inhibitor deucravacitinib in adults with moderate to severe plaque psoriasis through meta-analysis. METHODS: A systematic search was performed for eligible studies using electronic databases, including PubMed, Embase, Cochrane Library, Clinical Trials, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform (ICTRP). Randomized controlled trials (RCTs) comparing the efficacy and safety of deucravacitinib vs. placebo or active comparators in adult patients with plaque psoriasis were included. The effectiveness of deucravacitinib was evaluated using a 75% improvement in Psoriasis Area and Severity Index (PASI 75) from baseline and the proportion of patients achieving the static Physician's Global Assessment (sPGA) response. The secondary endpoint was the proportion of patients achieving PASI 90, PASI 100, ssPGA 0/1, and Dermatology Life Quality Index 0/1 (DLQI). The incidence of adverse events (AEs), serious AEs (SAEs), and AE-related treatment discontinuation were statistically analyzed to determine the safety of deucravacitinib. RESULTS: The systematic review and meta-analysis included five RCTs involving 2,198 patients with moderate to severe plaque psoriasis. Results showed that deucravacitinib was superior to placebo as well as active comparator apremilast in multiple key endpoints, including PASI 75, sPGA 0/1, PASI 90, PASI 100, DLQI 0/1 at week 16. Moreover, a durable response was seen in the two 52-week studies. Safety assessment showed that deucravacitinib was generally well tolerated, and the incidence of AEs, SAEs, and AE-related treatment discontinuation was low and balanced across groups. CONCLUSION: Deucravacitinib demonstrated superior efficacy to apremilast in adult patients with moderate to severe plaque psoriasis with an acceptable safety profile and has the potential to be used as the first-line oral therapy for plaque psoriasis.
背景：临床实践中需要疗效更佳、毒性更低且成本更低的斑块状银屑病口服治疗药物。本研究旨在通过荟萃分析评估近期获批的酪氨酸激酶2（TYK2）抑制剂氘可来昔替尼在中度至重度斑块状银屑病成人患者中的疗效和安全性。 方法：使用电子数据库进行系统检索以查找符合条件的研究，这些数据库包括PubMed、Embase、Cochrane图书馆、临床试验、欧盟临床试验注册库和国际临床试验注册平台（ICTRP）。纳入比较氘可来昔替尼与安慰剂或活性对照药在斑块状银屑病成人患者中的疗效和安全性的随机对照试验（RCT）。使用银屑病面积和严重程度指数（PASI）较基线改善75%以及达到静态医师整体评估（sPGA）缓解的患者比例来评估氘可来昔替尼的有效性。次要终点是达到PASI 90、PASI 100、静态医师整体评估0/1（ssPGA 0/1）和皮肤病生活质量指数0/1（DLQI）的患者比例。对不良事件（AE）、严重不良事件（SAE）的发生率以及与AE相关的治疗停药情况进行统计分析，以确定氘可来昔替尼的安全性。 结果：该系统评价和荟萃分析纳入了5项RCT，涉及2198例中度至重度斑块状银屑病患者。结果显示，在多个关键终点上，氘可来昔替尼优于安慰剂以及活性对照药阿普米司特，包括第16周时的PASI 75、sPGA 0/1、PASI 90、PASI 100、DLQI 0/1。此外，在两项为期52周的研究中观察到了持久的缓解。安全性评估表明，氘可来昔替尼总体耐受性良好，AE、SAE的发生率以及与AE相关的治疗停药率较低，且各治疗组之间均衡。 结论：在中度至重度斑块状银屑病成人患者中，氘可来昔替尼显示出优于阿普米司特的疗效，安全性可接受，有潜力用作斑块状银屑病的一线口服治疗药物。
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