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低剂量利妥昔单抗治疗天疱疮的疗效和安全性:一项更新的系统评价和荟萃分析

Efficacy and safety of low dose rituximab in pemphigus: an updated systematic review and meta-analysis.

作者信息

Liu Si-Han, Wang Si-Hang, Zuo Ya-Gang

机构信息

Department of Dermatology, State Key Laboratory of Complex Severe and Rare Diseases, National Clinical Research Center for Dermatologic and Immunologic Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

出版信息

Front Immunol. 2025 Jul 25;16:1605243. doi: 10.3389/fimmu.2025.1605243. eCollection 2025.

DOI:10.3389/fimmu.2025.1605243
PMID:40787442
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12331757/
Abstract

OBJECTIVE

To evaluate the efficacy and safety of low-dose rituximab (RTX) in the treatment of pemphigus.

METHODS

A systematic literature search was conducted across PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov to identify eligible studies. Primary efficacy outcomes included complete remission (CR), relapse rates, time to disease control (TDC), time to CR, and cumulative corticosteroid dose. Safety outcomes were assessed by meticulously documenting adverse events (AEs) and concomitant medications reported in each study.

RESULTS

The final analysis incorporated five comparative studies and nine single-arm studies investigating the efficacy and safety outcomes of low-dose RTX. Comparative data revealed no statistically significant differences between the high-dose and low-dose RTX groups in CR, relapse rates, TDC, time to CR, and cumulative corticosteroid dose. In single-arm studies, pooled CR and relapse rates were 63.2% and 28.6%, respectively. No fatal events were reported; however, severe AEs, including pneumonia and sepsis, were documented in the low-dose RTX cohort.

CONCLUSION

Low-dose RTX exhibited comparable clinical efficacy to high-dose RTX regimens in pemphigus management. However, clinicians should remain vigilant for potential AEs associated with low-dose RTX infusion.

摘要

目的

评估低剂量利妥昔单抗(RTX)治疗天疱疮的疗效和安全性。

方法

在PubMed、Embase、Cochrane图书馆和ClinicalTrials.gov上进行系统的文献检索,以确定符合条件的研究。主要疗效指标包括完全缓解(CR)、复发率、疾病控制时间(TDC)、达到CR的时间和累积皮质类固醇剂量。通过仔细记录每项研究中报告的不良事件(AE)和伴随用药来评估安全性指标。

结果

最终分析纳入了五项比较研究和九项单臂研究,以调查低剂量RTX的疗效和安全性指标。比较数据显示,高剂量和低剂量RTX组在CR、复发率、TDC、达到CR的时间和累积皮质类固醇剂量方面无统计学显著差异。在单臂研究中,汇总的CR率和复发率分别为63.2%和28.6%。未报告致命事件;然而,低剂量RTX队列中记录了包括肺炎和败血症在内的严重AE。

结论

在天疱疮治疗中,低剂量RTX与高剂量RTX方案具有相当的临床疗效。然而,临床医生应警惕与低剂量RTX输注相关的潜在AE。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/534a/12331757/4424a26c2fbb/fimmu-16-1605243-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/534a/12331757/ec7622afc807/fimmu-16-1605243-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/534a/12331757/ac50aa328e18/fimmu-16-1605243-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/534a/12331757/4d11e9295aba/fimmu-16-1605243-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/534a/12331757/4424a26c2fbb/fimmu-16-1605243-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/534a/12331757/ec7622afc807/fimmu-16-1605243-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/534a/12331757/ac50aa328e18/fimmu-16-1605243-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/534a/12331757/4d11e9295aba/fimmu-16-1605243-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/534a/12331757/4424a26c2fbb/fimmu-16-1605243-g004.jpg

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本文引用的文献

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A study of ultralow dose rituximab as adjuvant to standard of care in treatment of significant and extensive pemphigus vulgaris: A case series.一项关于超低剂量利妥昔单抗作为标准治疗辅助药物治疗重度广泛性寻常型天疱疮的病例系列研究。
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Is It Time to Reconsider Rituximab Dosing Regimens for Pemphigus Vulgaris?是时候重新考虑寻常型天疱疮的利妥昔单抗给药方案了吗?
Antibodies (Basel). 2024 Jan 5;13(1):4. doi: 10.3390/antib13010004.
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The efficacy and safety of low-dose rituximab in the treatment of pemphigus vulgaris: a cohort study.
低剂量利妥昔单抗治疗寻常型天疱疮的疗效和安全性:一项队列研究。
J Dermatolog Treat. 2024 Dec;35(1):2302071. doi: 10.1080/09546634.2024.2302071. Epub 2024 Jan 22.
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Three cases of refractory bullous pemphigoid in the elderly treated successfully with ultra-low-dose rituximab.三例老年难治性大疱性类天疱疮患者经超低剂量利妥昔单抗治疗成功。
J Dermatol. 2023 Apr;50(4):561-564. doi: 10.1111/1346-8138.16668. Epub 2022 Dec 20.
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Low-Dose Rituximab for Bullous Pemphigoid. Protocol and Single-Center Experience.
Actas Dermosifiliogr. 2023 Jan;114(1):62-68. doi: 10.1016/j.ad.2021.10.018. Epub 2022 Jul 20.
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Clinical observation of different doses of rituximab for the treatment of severe pemphigus: A single-center prospective cohort study.不同剂量利妥昔单抗治疗重度天疱疮的临床观察:一项单中心前瞻性队列研究。
J Am Acad Dermatol. 2023 Feb;88(2):500-502. doi: 10.1016/j.jaad.2022.06.1187. Epub 2022 Jun 30.
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