类风湿关节炎患者接受阿巴接受或安慰剂治疗的间质性肺疾病事件发生率，背景为甲氨蝶呤：一项来自临床试验摘要的事后汇总分析

IF 4.4 2区医学 Q1 RHEUMATOLOGY

Seminars in arthritis and rheumatism Pub Date : 2025-07-16 DOI:10.1016/j.semarthrit.2025.152795

Philippe Dieudé , Jeffrey A. Sparks , Aryeh Fischer , Leo Chen , Karissa Lozenski , Stephanie Dahan , Mark Chaballa , Wayne Little

{"title":"类风湿关节炎患者接受阿巴接受或安慰剂治疗的间质性肺疾病事件发生率，背景为甲氨蝶呤：一项来自临床试验摘要的事后汇总分析","authors":"Philippe Dieudé , Jeffrey A. Sparks , Aryeh Fischer , Leo Chen , Karissa Lozenski , Stephanie Dahan , Mark Chaballa , Wayne Little","doi":"10.1016/j.semarthrit.2025.152795","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Interstitial lung disease (ILD) is a common and serious complication of rheumatoid arthritis (RA) and is associated with increased morbidity, mortality, and healthcare resource utilization.</div></div><div><h3>Objective</h3><div>To determine incidence rates (IRs) of ILD events in patients enrolled in clinical trials for RA who received abatacept + methotrexate (MTX) versus placebo + MTX.</div></div><div><h3>Methods</h3><div>We performed a retrospective analysis of pooled safety data from 10 phase 3 clinical trials of adult patients. ILD events included acute respiratory events suggestive of pneumonitis/ILD. Crude IRs per 100 person-years for baseline demographics and disease characteristics within treatment groups and IR ratios (IRRs) for placebo + MTX versus abatacept + MTX were estimated.</div></div><div><h3>Results</h3><div>Overall, 3708 (10,521 person-years) were treated with abatacept + MTX and 999 patients were treated with placebo + MTX (938 person-years). Patients treated with abatacept + MTX had a lower rate of ILD events versus patients treated with placebo + MTX: IR (95 % CI) 0.10 (0.05–0.18) versus 0.43 (0.16–1.14), respectively (IRR [95 % CI] 4.49 [1.23–13.42] for placebo + MTX vs abatacept + MTX). Patients with RA aged ≥ 55 years, body mass index < 30 kg/m<sup>2</sup>, no history of smoking, no baseline disease-modifying antirheumatic drug use other than MTX, no prior tumor necrosis factor inhibitor use, high DAS28-CRP, and rheumatoid factor or anti-citrullinated protein antibody positivity who were receiving corticosteroid(s) had a significantly lower rate of ILD events if treated with abatacept + MTX versus placebo + MTX.</div></div><div><h3>Conclusion</h3><div>In this <em>post hoc</em> analysis, patients with RA who received abatacept had a lower rate of ILD events, including the subgroups of older age, lower body mass index, and no smoking history, compared with placebo. This warrants further investigation in prospective, controlled studies.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"74 ","pages":"Article 152795"},"PeriodicalIF":4.4000,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Incidence rates of interstitial lung disease events among patients with rheumatoid arthritis treated with abatacept or placebo, with background methotrexate: a post hoc pooled analysis from a compendium of clinical trials\",\"authors\":\"Philippe Dieudé , Jeffrey A. Sparks , Aryeh Fischer , Leo Chen , Karissa Lozenski , Stephanie Dahan , Mark Chaballa , Wayne Little\",\"doi\":\"10.1016/j.semarthrit.2025.152795\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Interstitial lung disease (ILD) is a common and serious complication of rheumatoid arthritis (RA) and is associated with increased morbidity, mortality, and healthcare resource utilization.</div></div><div><h3>Objective</h3><div>To determine incidence rates (IRs) of ILD events in patients enrolled in clinical trials for RA who received abatacept + methotrexate (MTX) versus placebo + MTX.</div></div><div><h3>Methods</h3><div>We performed a retrospective analysis of pooled safety data from 10 phase 3 clinical trials of adult patients. ILD events included acute respiratory events suggestive of pneumonitis/ILD. Crude IRs per 100 person-years for baseline demographics and disease characteristics within treatment groups and IR ratios (IRRs) for placebo + MTX versus abatacept + MTX were estimated.</div></div><div><h3>Results</h3><div>Overall, 3708 (10,521 person-years) were treated with abatacept + MTX and 999 patients were treated with placebo + MTX (938 person-years). Patients treated with abatacept + MTX had a lower rate of ILD events versus patients treated with placebo + MTX: IR (95 % CI) 0.10 (0.05–0.18) versus 0.43 (0.16–1.14), respectively (IRR [95 % CI] 4.49 [1.23–13.42] for placebo + MTX vs abatacept + MTX). Patients with RA aged ≥ 55 years, body mass index < 30 kg/m<sup>2</sup>, no history of smoking, no baseline disease-modifying antirheumatic drug use other than MTX, no prior tumor necrosis factor inhibitor use, high DAS28-CRP, and rheumatoid factor or anti-citrullinated protein antibody positivity who were receiving corticosteroid(s) had a significantly lower rate of ILD events if treated with abatacept + MTX versus placebo + MTX.</div></div><div><h3>Conclusion</h3><div>In this <em>post hoc</em> analysis, patients with RA who received abatacept had a lower rate of ILD events, including the subgroups of older age, lower body mass index, and no smoking history, compared with placebo. This warrants further investigation in prospective, controlled studies.</div></div>\",\"PeriodicalId\":21715,\"journal\":{\"name\":\"Seminars in arthritis and rheumatism\",\"volume\":\"74 \",\"pages\":\"Article 152795\"},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2025-07-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Seminars in arthritis and rheumatism\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0049017225001660\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Seminars in arthritis and rheumatism","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0049017225001660","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

背景：间质性肺疾病（ILD）是类风湿性关节炎（RA）常见且严重的并发症，与发病率、死亡率和医疗资源利用率增加有关。目的确定接受阿巴接受+甲氨蝶呤（MTX）与安慰剂+ MTX治疗的RA临床试验患者ILD事件的发生率（IRs）。方法：我们对10项成人患者的3期临床试验的安全性数据进行回顾性分析。ILD事件包括提示肺炎/ILD的急性呼吸事件。估计了治疗组内基线人口统计学和疾病特征的每100人年的粗IR，以及安慰剂+ MTX与阿巴接受+ MTX的IR比（IRRs）。结果总体而言，3708例（10,521人年）患者接受阿巴接受+ MTX治疗，999例患者接受安慰剂+ MTX治疗（938人年）。接受abatacept + MTX治疗的患者与安慰剂+ MTX治疗的患者相比，ILD事件发生率较低：IR (95% CI) 0.10（0.05-0.18）对0.43(0.16-1.14)，分别为（安慰剂+ MTX vs abatacept + MTX的IRR [95% CI] 4.49[1.23-13.42]）。RA患者年龄≥55岁，体重指数<；30 kg/m2，无吸烟史，基线无MTX以外的疾病改善抗风湿药物使用，既往无肿瘤坏死因子抑制剂使用，DAS28-CRP高，类风湿因子或抗瓜氨酸化蛋白抗体阳性，接受皮质类固醇治疗的患者，如果接受阿巴接受普+ MTX治疗，ILD事件发生率明显低于安慰剂+ MTX。结论：在这项事后分析中，与安慰剂相比，接受abataccept治疗的RA患者的ILD事件发生率较低，包括年龄较大、体重指数较低和无吸烟史的亚组。这需要在前瞻性对照研究中进一步调查。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Incidence rates of interstitial lung disease events among patients with rheumatoid arthritis treated with abatacept or placebo, with background methotrexate: a post hoc pooled analysis from a compendium of clinical trials

Background

Interstitial lung disease (ILD) is a common and serious complication of rheumatoid arthritis (RA) and is associated with increased morbidity, mortality, and healthcare resource utilization.

Objective

To determine incidence rates (IRs) of ILD events in patients enrolled in clinical trials for RA who received abatacept + methotrexate (MTX) versus placebo + MTX.

Methods

We performed a retrospective analysis of pooled safety data from 10 phase 3 clinical trials of adult patients. ILD events included acute respiratory events suggestive of pneumonitis/ILD. Crude IRs per 100 person-years for baseline demographics and disease characteristics within treatment groups and IR ratios (IRRs) for placebo + MTX versus abatacept + MTX were estimated.

Results

Overall, 3708 (10,521 person-years) were treated with abatacept + MTX and 999 patients were treated with placebo + MTX (938 person-years). Patients treated with abatacept + MTX had a lower rate of ILD events versus patients treated with placebo + MTX: IR (95 % CI) 0.10 (0.05–0.18) versus 0.43 (0.16–1.14), respectively (IRR [95 % CI] 4.49 [1.23–13.42] for placebo + MTX vs abatacept + MTX). Patients with RA aged ≥ 55 years, body mass index < 30 kg/m², no history of smoking, no baseline disease-modifying antirheumatic drug use other than MTX, no prior tumor necrosis factor inhibitor use, high DAS28-CRP, and rheumatoid factor or anti-citrullinated protein antibody positivity who were receiving corticosteroid(s) had a significantly lower rate of ILD events if treated with abatacept + MTX versus placebo + MTX.

Conclusion

In this post hoc analysis, patients with RA who received abatacept had a lower rate of ILD events, including the subgroups of older age, lower body mass index, and no smoking history, compared with placebo. This warrants further investigation in prospective, controlled studies.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

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.