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德瓦鲁单抗治疗中重度斑块型银屑病的安全性和有效性：一项荟萃分析。

Safety and efficacy of Deucravacitinib for moderate to severe plaque psoriasis: A meta-analysis.

机构信息

Department of Dermatology, the Forth Hospital of Hebei Medical University, Shijiazhuang, China.

出版信息

Skin Res Technol. 2024 Aug;30(8):e13855. doi: 10.1111/srt.13855.

DOI:10.1111/srt.13855
PMID:39180322
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11344170/
Abstract

BACKGROUND

To systematically evaluate the safety and efficacy of Deucravacitinib for moderate to severe plaque psoriasis.

MATERIALS AND METHODS

Randomized controlled trials (RCTs) of Deucravacitinib for moderate to severe plaque psoriasis in PubMed, Cochrane Library, Embase, and Web of Science were searched from database establishment to April 2023. Literature quality was independently evaluated by two investigators using the Cochrane risk-of-bias assessment tool, and the systematic analysis was made using StateSE15 and RevMan 5.3 software.

RESULTS

Four RCTs were included, including 1751 patients with moderate to severe plaque psoriasis. Meta-analysis showed that the differences in efficacy and adverse events (AEs) between the Deucravacitinib group and placebo group were significant (p < 0.05). The patients in the Deucravacitinib group took orally 3-12 mg daily for 12 sequential weeks or 6 mg daily for 52 sequential weeks. Psoriasis Area and Severity Index (PASI) reduced by 75% (PASI 75), (PASI 90), and (PASI 100), static Physician Global Assessment (sPGA) of 0 or 1 (sPGA 0/1), Dermatology Life Quality Index of 0 or 1 (DLQI 0/1), and Psoriasis Symptoms and Signs Diary (PSSD) were significantly higher in the Deucravacitinib group compared to the placebo group, with significant differences (p < 0.05). The most frequently encountered AEs after treatment in the Deucravacitinib group was nasopharyngitis.

CONCLUSION

Oral administration of Deucravacitinib is effective for moderate to severe plaque psoriasis. Attention should be paid to the occurrence of AEs, and more RCTs are required to evaluate the relationship between the dose and safety and efficacy.

摘要

背景

系统评估德瓦鲁单抗治疗中重度斑块状银屑病的安全性和有效性。

材料和方法

从数据库建立到 2023 年 4 月，在 PubMed、Cochrane 图书馆、Embase 和 Web of Science 中检索德瓦鲁单抗治疗中重度斑块状银屑病的随机对照试验（RCT）。两位研究者使用 Cochrane 偏倚风险评估工具独立评估文献质量，并使用 StateSE15 和 RevMan 5.3 软件进行系统分析。

结果

纳入 4 项 RCT，共 1751 例中重度斑块状银屑病患者。Meta 分析结果显示，德瓦鲁单抗组与安慰剂组在疗效和不良反应（AE）方面的差异均有统计学意义（p<0.05）。德瓦鲁单抗组患者每日口服 3-12 mg，连续服用 12 周或每日 6 mg，连续服用 52 周。治疗后，德瓦鲁单抗组患者的银屑病面积和严重程度指数（PASI）75 缓解率（PASI 75）、90 缓解率（PASI 90）、100 缓解率（PASI 100）、静态医师整体评估（sPGA）0/1 缓解率（sPGA 0/1）、皮肤病生活质量指数（DLQI）0/1 缓解率（DLQI 0/1）、银屑病症状和体征日记（PSSD）评分均显著高于安慰剂组，差异有统计学意义（p<0.05）。德瓦鲁单抗组治疗后最常见的不良反应是鼻咽炎。

结论

口服德瓦鲁单抗治疗中重度斑块状银屑病有效。应注意不良反应的发生，需要更多 RCT 来评估剂量与安全性和疗效之间的关系。

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