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与多种生物制剂和小分子药物相比,德卡伐替尼在皮肤红斑狼疮中显示出更优的疗效和安全性——一项系统评价和荟萃分析。

Deucravacitinib shows superior efficacy and safety in cutaneous lupus erythematosus compared to various biologics and small molecules - A systematic review and meta-analysis.

作者信息

Bokor Laura Anna, Martyin Katalin, Krebs Máté, Galajda Noémi Ágnes, Meznerics Fanni Adél, Szabó Bence, Hegyi Péter, Lőrincz Kende, Kiss Norbert, Bánvölgyi András, Hidvégi Bernadett

机构信息

Department of Dermatology, Venereology and Dermatooncology, Faculty of Medicine, Semmelweis University, 41 Mária Street, Budapest 1085, Hungary; Centre for Translational Medicine, Semmelweis University, 22 Baross Street, Budapest 1085, Hungary.

Centre for Translational Medicine, Semmelweis University, 22 Baross Street, Budapest 1085, Hungary.

出版信息

Autoimmun Rev. 2025 Feb 28;24(3):103723. doi: 10.1016/j.autrev.2024.103723. Epub 2024 Dec 16.

Abstract

BACKGROUND

Novel therapies for cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) demonstrated efficacy and safety in previous trials. However, data on the comparison of these treatments is still lacking, limiting their integration into clinical practice. Therefore, our aim is to perform a systematic review and network meta-analysis to compare the efficacy and safety of novel systemic therapies in CLE.

METHODS

A systematic search was performed across PubMed, Embase, and CENTRAL on November 25, 2023, to identify studies involving patients with CLE or SLE with active skin involvement treated with novel systemic therapies. The primary outcomes assessed were the proportion of patients achieving the Cutaneous Lupus Erythematosus Disease Area and Severity Index-50 (CLASI-50), the change in CLASI-A, the occurrence of adverse events (AEs), and serious adverse events (SAEs).

RESULTS

18,280 records were retrieved, of which 53 met the inclusion criteria. Deucravacitinib showed significantly greater efficacy in achieving the CLASI50 compared to placebo (OR: 8.28, 95 % CI: 2.22-30.91). Both litifilimab (OR: 2.54, 95 % CI: 1.20-5.40) and anifrolumab (OR: 2.25, 95 % CI: 1.23-4.14) were also significantly more effective than placebo. No significant differences were observed in the occurrence of AEs and SAEs between these therapeutics and placebo.

CONCLUSION

Anifrolumab and litifilimab are effective and safe treatment options in CLE. However, deucravacitinib demonstrated superior efficacy and safety with fewer adverse events compared to anifrolumab. CLE patients who have shown an inadequate response to first- and second-line treatments may benefit from the incorporation of deucravacitinib into their treatment regimens.

摘要

背景

用于治疗皮肤型红斑狼疮(CLE)和系统性红斑狼疮(SLE)的新型疗法在既往试验中已证明其有效性和安全性。然而,关于这些治疗方法比较的数据仍然缺乏,这限制了它们在临床实践中的应用。因此,我们的目的是进行一项系统评价和网状Meta分析,以比较CLE中新型全身治疗的疗效和安全性。

方法

于2023年11月25日在PubMed、Embase和CENTRAL数据库中进行系统检索,以识别涉及接受新型全身治疗的有活动性皮肤受累的CLE或SLE患者的研究。评估的主要结局包括达到皮肤红斑狼疮疾病面积和严重程度指数-50(CLASI-50)的患者比例、CLASI-A的变化、不良事件(AE)的发生情况以及严重不良事件(SAE)。

结果

共检索到18280条记录,其中53条符合纳入标准。与安慰剂相比,德卡伐替尼在达到CLASI50方面显示出显著更高的疗效(OR:8.28,95%CI:2.22-30.91)。利蒂菲利单抗(OR:2.54,95%CI:1.20-5.40)和阿尼氟单抗(OR:2.25,95%CI:1.23-4.14)也比安慰剂显著更有效。在这些治疗方法与安慰剂之间,AE和SAE的发生情况未观察到显著差异。

结论

阿尼氟单抗和利蒂菲利单抗是治疗CLE的有效且安全的选择。然而,与阿尼氟单抗相比,德卡伐替尼显示出更高的疗效和安全性,不良事件更少。对一线和二线治疗反应不佳的CLE患者可能会受益于将德卡伐替尼纳入其治疗方案。

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