Narváez Javier, Aguilar-Coll Martí, Roig-Kim Montserrat, Palacios-Olid Judith, Maymó-Paituvi Pol, de Daniel-Bisbe Laia, LLop Dídac
Department of Rheumatology, Hospital Universitario de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.
Department of Rheumatology, Hospital Universitario de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.
Autoimmun Rev. 2025 May 30;24(6):103804. doi: 10.1016/j.autrev.2025.103804. Epub 2025 Mar 14.
To evaluate the efficacy, safety, and tolerability of antifibrotic agents, nintedanib and pirfenidone, in the treatment of rheumatoid arthritis-associated interstitial lung disease (RA-ILD).
A systematic literature review was conducted following PRISMA and MOOSE guidelines. Studies assessing nintedanib or pirfenidone in RA-ILD were included. A meta-analysis was performed using a random-effects model.
Six studies (2 randomized controlled trials and 4 observational) involving 270 RA-ILD patients met the inclusion criteria. In total, 148 received nintedanib and 122 received pirfenidone. Nearly 70 % had a usual interstitial pneumonia pattern. The pooled analysis revealed a mean FVC decline of -68.97 mL/year (95 % CI: -104.85 to -32.49; p < 0.001) and a mean difference of 1.15 % (p = 0.33; after excluding influential studies: -0.28, p = 0.54). Their impact on %pDLCO has been less extensively evaluated, with a mean difference of -1.76 % (p = 0.36; after excluding influential studies: effect size -3.78, p < 0.001). The changes in pulmonary function tests were comparable between nintedanib and pirfenidone. Mortality rates ranged from 15 % to 35 %, with respiratory-specific mortality reported at 44 % to 100 %. Lung transplantation rates were 4-5 %. Antifibrotic therapy was associated with a pooled adverse event (AE) rate of 73 % (95 % CI: 0.38-0.97; p < 0.001), with gastrointestinal symptoms and hepatotoxicity being the most frequently reported. Treatment discontinuation due to AEs occurred in nearly 24 % of patients (95 % CI: 0.16-0.40; p < 0.001).
Antifibrotic agents demonstrated stabilization of %pFVC, with less robust evidence for %pDLCO in RA-ILD. Nearly one quarter of patients discontinued therapy due to AEs.
评估抗纤维化药物尼达尼布和吡非尼酮治疗类风湿关节炎相关间质性肺病（RA - ILD）的疗效、安全性和耐受性。
按照PRISMA和MOOSE指南进行系统文献综述。纳入评估尼达尼布或吡非尼酮治疗RA - ILD的研究。采用随机效应模型进行荟萃分析。
六项研究（2项随机对照试验和4项观察性研究）涉及270例RA - ILD患者，符合纳入标准。其中，148例接受尼达尼布治疗，122例接受吡非尼酮治疗。近70%患者表现为普通型间质性肺炎模式。汇总分析显示，用力肺活量（FVC）平均每年下降68.97 mL（95%置信区间：-104.85至-32.49；p < 0.001），平均差异为1.15%（p = 0.33；排除有影响的研究后：-0.28，p = 0.54）。它们对肺一氧化碳弥散量百分比（%pDLCO）的影响评估较少，平均差异为-1.76%（p = 0.36；排除有影响的研究后：效应量-3.78，p < 0.001）。尼达尼布和吡非尼酮在肺功能测试变化方面相当。死亡率在15%至35%之间，报告的呼吸系统特异性死亡率为44%至100%。肺移植率为4% - 5%。抗纤维化治疗的汇总不良事件（AE）发生率为73%（95%置信区间：0.38 - 0.97；p < 0.001），最常报告的是胃肠道症状和肝毒性。近24%的患者因不良事件停药（95%置信区间：0.16 - 0.40；p < 0.001）。
抗纤维化药物在RA - ILD中显示出%pFVC稳定，而对%pDLCO的证据较弱。近四分之一的患者因不良事件停药。
