Real-world evidence of the antifibrotic nintedanib in rheumatoid arthritis-interstitial lung disease. National multicenter study of 74 patients

IF 4.6 2区医学 Q1 RHEUMATOLOGY

Seminars in arthritis and rheumatism Pub Date : 2025-03-14 DOI:10.1016/j.semarthrit.2025.152710

Belén Atienza-Mateo , Ana Serrano-Combarro , Jesús Loarce Martos , Nuria Vegas-Revenga , María Martín López , Santos Castañeda , Rafael B. Melero-González , Natalia Mena Vázquez , Carmen Carrasco-Cubero , Carolina Díez Morrondo , David Castro Corredor , Tomás Ramón Vázquez Rodríguez , Andrea García Valle , Gema Bonilla , Marina Rodríguez López , Ignacio Braña Abascal , Sara María Rojas Herrera , Juan C Sarmiento-Monroy , Pablo Andújar Brazal , Diego Ferrer , Christian Omar Anchorena Diaz

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Abstract

Objective

To assess the effectiveness and safety of the antifibrotic drug nintedanib in rheumatoid arthritis (RA)-related interstitial lung disease (ILD) and a progressive phenotype in clinical practice.

Methods

National Spanish multicenter study of RA-ILD patients to whom nintedanib was added due to progressive fibrosing ILD. Outcome variables were effectiveness, retention rate and safety. Forced vital capacity (FVC) evolution was the primary endpoint. A comparative study between our cohort and those RA-ILD patients included in the INBUILD trial (n = 89, 42 treated with nintedanib) was performed.

Results

A total of 74 patients (31 women/43 men) were collected, mean age of 69.3 ± 8.8 years. Median [IQR] ILD duration up to antifibrotic initiation was 51 [22–77.5] months. Besides corticosteroids (n = 54), nintedanib was used combined with cDMARD (n = 21), bDMARD (n = 46) and/or JAKi (n = 4) and monotherapy (n = 3). Mean FVC one year before nintedanib start was 81.9 ± 21.2 (% pred.), whilst mean baseline FVC was 73.7 ± 22.5 (% pred.). After a median follow-up of 15 [10–22, 4–9] months, no significant decline in mean FVC or DLCO values was observed. Moreover, the evolution of DLCO and FVC significantly differed from a predictive model that assumed their changes without the drug. The retention rate with nintedanib was 78.4 %. During the follow up, 16.7 % of patients showed ILD progression or progressive pulmonary fibrosis. Gastrointestinal adverse events were the most common reason for nintedanib discontinuation. Compared with INBUILD trial, patients from clinical practice were older, had a higher tobacco exposure, time since ILD diagnosis was longer and treatment with combined immunosuppressants was more frequent. However, baseline mean values of FVC and DLCO were similar in both groups.

Conclusion

Nintedanib seems to be effective and relatively safe in progressive fibrosing RA-ILD despite clinical differences with the INBUILD trial.

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目的评估抗纤维化药物宁替达尼对类风湿性关节炎（RA）相关间质性肺病（ILD）和临床实践中进展性表型的有效性和安全性：西班牙全国性多中心研究：对因进展性纤维化ILD而加用宁替尼的RA-ILD患者进行研究。结果变量为有效性、保留率和安全性。强迫生命容量（FVC）的变化是主要终点。我们的队列与INBUILD试验中的RA-ILD患者（n = 89，42例接受了宁替尼治疗）进行了比较研究：共收集了 74 名患者（31 名女性/43 名男性），平均年龄为 69.3 ± 8.8 岁。中位数[IQR]ILD持续时间为51[22-77.5]个月。除皮质类固醇（54例）外，nintedanib还与cDMARD（21例）、bDMARD（46例）和/或JAKi（4例）联合使用，以及单药治疗（3例）。开始使用宁替达尼前一年的平均 FVC 为 81.9 ± 21.2（预测值%），而平均基线 FVC 为 73.7 ± 22.5（预测值%）。中位随访 15 [10-22, 4-9] 个月后，未观察到平均 FVC 或 DLCO 值有明显下降。此外，DLCO 和 FVC 的变化与假定不用药时的预测模型有明显差异。宁替达尼的保留率为78.4%。在随访期间，16.7%的患者出现了ILD进展或进行性肺纤维化。胃肠道不良事件是宁替尼停药的最常见原因。与INBUILD试验相比，临床实践中的患者年龄更大，烟草暴露率更高，确诊ILD的时间更长，接受联合免疫抑制剂治疗的频率更高。然而，两组患者的FVC和DLCO基线平均值相似：结论：尽管与INBUILD试验存在临床差异，但奈替达尼似乎对进行性纤维化RA-ILD有效且相对安全。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.