免疫介导的炎症性疾病的综合疗法：使用巴黎医院公共援助临床数据仓库的研究

IF 4.6 2区医学 Q1 RHEUMATOLOGY

Seminars in arthritis and rheumatism Pub Date : 2025-02-14 DOI:10.1016/j.semarthrit.2025.152660

Anne-Laure Gérard , Matheus Vieira , Ariel Cohen , Olivier Hassanaly , Jérôme Lambert , David Saadoun

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引用次数: 0

摘要

不同生物和靶向合成DMARDs的联合治疗（即联合治疗）最近出现在免疫介导的炎症性疾病（IMID）的治疗中。然而，缺乏跨专业和与联合治疗相关的预后因素的实际数据。方法使用巴黎医院公共援助临床数据仓库进行多中心观察性研究，包括接受联合治疗的IMID患者和匹配的单一治疗对照组。主要终点是严重不良事件（SAE）的发生，定义为严重感染、主要心血管事件、肿瘤和死亡率（全因）。从42,071名患有IMID的受试者中，在2017年至2022年期间，在125名患者（中位年龄36岁，58%为女性）中确定了131种联合治疗方案。最常见的IMIDs是炎症性肠病（48.8%）、结缔组织病（23.2%）、炎症性肌病（14.4%）和血管炎（11.2%）。中位随访15个月后[IQR 19]， 30例（24%）患者出现严重感染，5例（4%）出现肿瘤，4例（3.2%）出现静脉血栓栓塞，3例（2.4%）出现急性冠状动脉综合征，7例（5.6%）死亡。1年累积SAE和严重感染发生率分别为29% （95% CI 21-38）和24% （95% CI 16-32）。调整混杂因素后，联合治疗患者的生存率、SAE发生率和严重感染与单一治疗对照组（n=251）相比无统计学差异。在多变量分析中，我们发现abat接受+ JAKi （HR 6.81, 95% CI 1.88-24.68）、抗il -1 （HR 4.82, 95% CI 1.17-19.89）和抗cd20 （HR 4.03, 95% CI 1.22-13.31）联合治疗与SAE风险增加独立相关。结论：与单一治疗相比，联合治疗的SAE总体风险似乎没有显著增加，但某些联合治疗需要谨慎。联合治疗组合物似乎可以预测安全性结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Combotherapies in immune-mediated inflammatory diseases: A study using the Clinical Data Warehouse from Paris Hospitals’ Public Assistance

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Combotherapies in immune-mediated inflammatory diseases: A study using the Clinical Data Warehouse from Paris Hospitals’ Public Assistance

Background

The combination of different biological and targeted synthetic DMARDs (i.e., combotherapy) has recently emerged in the management of immune-mediated inflammatory diseases (IMID). However, real-life data across specialities and prognostic factors related to combotherapy are lacking.

Methods

Multicenter observational study conducted using the Clinical Data Warehouse from Paris Hospitals’ Public Assistance including IMID patients under combotherapy, and a matched monotherapy control group. The primary endpoint was the occurrence of serious adverse events (SAE), defined by severe infections, major cardiovascular events, neoplasia and mortality (all-cause).

Results

From 42,071 subjects having an IMID, 131 combotherapy lines were identified among 125 patients (median age of 36 years, 58 % females) between 2017 and 2022. The most frequent IMIDs were inflammatory bowel disease (48.8 %), connective tissue diseases (23.2 %), inflammatory myopathies (14.4 %) and vasculitis (11.2 %). After a median follow-up of 15 months [IQR 19], 30 (24 %) patients presented severe infections, 5 (4 %) neoplasia, 4 (3.2 %) venous thromboembolism, 3 (2.4 %) acute coronary syndromes and 7 (5.6 %) deaths. The 1-year cumulative incidence of SAE and severe infections were 29 % (95 %CI 21–38), and 24 % (95 %CI 16–32), respectively. The survival, incidence of SAE and severe infections were not statistically different from combotherapy patients compared to monotherapy controls (n=251) after adjustment for confounders. In multivariate analyses, we found abatacept + JAKi (HR 6.81, 95 %CI 1.88–24.68), anti-IL-1-based (HR 4.82, 95 %CI 1.17–19.89) and anti-CD20-based (HR 4.03, 95 %CI 1.22–13.31) combotherapies to be independently associated with an increased risk of SAE.

Conclusion

The overall risk of SAE under combotherapy does not seem greatly increased compared to monotherapy, but certain combinations warrant caution. The combotherapy composition seems predictive of safety outcomes.

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来源期刊

Seminars in arthritis and rheumatism 医学-风湿病学

CiteScore

9.20

自引率

4.00%

发文量

176

审稿时长

46 days

期刊介绍： Seminars in Arthritis and Rheumatism provides access to the highest-quality clinical, therapeutic and translational research about arthritis, rheumatology and musculoskeletal disorders that affect the joints and connective tissue. Each bimonthly issue includes articles giving you the latest diagnostic criteria, consensus statements, systematic reviews and meta-analyses as well as clinical and translational research studies. Read this journal for the latest groundbreaking research and to gain insights from scientists and clinicians on the management and treatment of musculoskeletal and autoimmune rheumatologic diseases. The journal is of interest to rheumatologists, orthopedic surgeons, internal medicine physicians, immunologists and specialists in bone and mineral metabolism.