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类风湿关节炎中托珠单抗从静脉制剂转换为皮下制剂:回顾性队列分析与系统文献综述

Switch from Intravenous to Subcutaneous Formulation of Tocilizumab in Rheumatoid Arthritis: Retrospective Cohort Analysis and Systematic Literature Review.

作者信息

Galoppini Giorgio, Garaffoni Carlo, Lotesoriere Andrea, Nogarin Federico, Bortoluzzi Alessandra, Govoni Marcello, Silvagni Ettore

机构信息

Department of Medical Sciences, Rheumatology Unit, University of Ferrara and Azienda Ospedaliero-Universitaria S. Anna, Cona (Ferrara), Italy.

出版信息

Biologics. 2025 Dec 4;19:713-727. doi: 10.2147/BTT.S555169. eCollection 2025.

Abstract

PURPOSE

Subcutaneous tocilizumab (SC-TCZ) is approved for rheumatoid arthritis (RA) management. During Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) pandemics, experiences of intravenous (IV)-to-SC TCZ switch in RA patients spread. We aimed to determine SC-TCZ maintenance, efficacy and safety in IV-to-SC TCZ switchers, combining a single center, retrospective cohort study and a systematic literature review (SLR).

PATIENTS AND METHODS

We included RA patients undergoing IV-to-SC TCZ switch (2015-2024); patients were grouped and evaluated according to maintenance of SC-TCZ ("Go on SC" group, GoS) or returning to IV-TCZ within 12 months (T2) ("Back IV" group, BI). SC-TCZ maintenance, disease activity, adverse events (AEs) were evaluated; a univariate regression analysis was performed to evaluate factors associated with a successful switch. The SLR was performed in accordance with PRISMA 2.0 guidelines and registered in PRSPERO (ID CRD42024523714), to search for relevant articles regarding maintenance of SC-TCZ after IV-to-SC switch, efficacy (assessed both clinically and with clinimetric tools) and safety of this strategy, as well as predictors of a successful IV-to-SC switch.

RESULTS

According to the success of SC-TCZ switch (T2), SC-TCZ maintenance rate was 43.3% (13/30 patients). A switch back to IV-TCZ was more likely if patients had higher baseline GH score (OR 1.05, 95% CI 1.01-1.10), and less likely if the IV-to-SC switch was agreed with treating physician (0.03, 0.00-0.21). At first visit after baseline, the mean DAS28 value diminished in GoS (-0.3) versus BI (+0.5), p < 0.001. No treatment-related serious AEs were reported. The SLR retrieved 12 articles (3626 patients), including 2 open-label randomized controlled trials (RCTs) and 10 observational studies. By the end of follow-up, SC-TCZ maintenance in our cohort was lower than in other experiences (25.9% versus 78.7%), but with a longer follow-up (up to 4.5 years).

CONCLUSION

Intravenous to subcutaneous tocilizumab switch is an effective and safe option in rheumatoid arthritis management, especially in the case of a shared decision.

摘要

目的

皮下注射托珠单抗(SC-TCZ)已被批准用于类风湿关节炎(RA)的治疗。在严重急性呼吸综合征冠状病毒2(SARS-CoV2)大流行期间,类风湿关节炎患者从静脉注射(IV)转换为皮下注射托珠单抗的经验不断传播。我们旨在通过一项单中心回顾性队列研究和系统文献综述(SLR),确定从静脉注射转换为皮下注射托珠单抗的患者中,皮下注射托珠单抗的维持情况、疗效和安全性。

患者和方法

我们纳入了2015年至2024年间从静脉注射转换为皮下注射托珠单抗的类风湿关节炎患者;根据皮下注射托珠单抗的维持情况(“继续使用皮下注射托珠单抗”组,GoS)或在12个月内恢复静脉注射托珠单抗(T2)(“转回静脉注射”组,BI)对患者进行分组和评估。评估皮下注射托珠单抗的维持情况、疾病活动度、不良事件(AE);进行单变量回归分析以评估与成功转换相关的因素。系统文献综述按照PRISMA 2.0指南进行,并在PROSPERO(ID CRD42024523714)注册,以搜索有关静脉注射转换为皮下注射后皮下注射托珠单抗的维持情况、疗效(通过临床和临床测量工具评估)和该策略的安全性,以及静脉注射到皮下注射成功转换的预测因素的相关文章。

结果

根据皮下注射托珠单抗转换的成功情况(T2),皮下注射托珠单抗的维持率为43.3%(30例患者中的13例)。如果患者基线GH评分较高,则更有可能转回静脉注射托珠单抗(OR 1.05,95% CI 1.01-1.10),而如果静脉注射到皮下注射的转换得到治疗医生的同意,则可能性较小(0.03,0.00-0.21)。在基线后的首次就诊时,GoS组的平均DAS28值下降(-0.3),而BI组上升(+0.5),p<0.001。未报告与治疗相关的严重不良事件。系统文献综述检索到12篇文章(3626例患者),包括2项开放标签随机对照试验(RCT)和10项观察性研究。到随访结束时,我们队列中皮下注射托珠单抗的维持率低于其他研究(25.9%对78.7%),但随访时间更长(长达4.5年)。

结论

静脉注射转换为皮下注射托珠单抗在类风湿关节炎治疗中是一种有效且安全的选择,尤其是在共同决策的情况下。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/120b/12684985/b0c19f425cad/BTT-19-713-g0001.jpg

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