Abatacept for the treatment of myositis-associated interstitial lung disease
作者:Rohit Aggarwal, Nantakarn Pongtarakulpanit, Daniel I. Sullivan, Siamak Moghadam‐Kia, Sangmee Bae, Jesse Wilkerson, Didem Saygın, Galina Marder, Swamy Venuturupalli, Paul F. Dellaripa, Sonye K. Danoff, Tracy J. Doyle, Gary M. Hunninghake, Joyce Lee, Aryeh Fischer, Jeremy Falk, Cheilonda Johnson, Diane Koontz, Dana P. Ascherman, Chester V. Oddis · 发表于:Lara D. Veeken · 年份:2025 · DOI:10.1093/rheumatology/keaf218 · 被引用次数:5 · 研究领域:Inflammatory Myopathies and Dermatomyositis、Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis、Spondyloarthritis Studies and Treatments
OBJECTIVES: This randomized, placebo-controlled pilot trial evaluated the efficacy and safety of abatacept in patients with anti-synthetase syndrome-associated interstitial lung disease (ASyS-ILD). METHODS: Participants with active ASyS-ILD were randomized to receive abatacept (n = 9) or placebo (n = 11) for 24 weeks, followed by a 24-week open-label extension with abatacept for all participants. The primary endpoint was a change in % predicted forced vital capacity (%FVC) from baseline to week 24. Secondary endpoints included changes in the FVC (ml), % predicted diffusing capacity of the lung for carbon monoxide (%DLCO), shortness of breath questionnaire (SOBQ) and pulmonary disease activity on a visual analogue scale (VAS) at weeks 24 and 48. Pre-post baseline analysis of FVC and quantitative image analysis (QIA) of high-resolution computed tomographic scans were performed. Data were analysed using a generalized linear mixed model. The study was not powered for primary or secondary endpoints. RESULTS: At week 24, there was no significant difference in the primary endpoint of %FVC change between abatacept and placebo (between treatment difference of -0.35, 95%CI -6.91 to 6.21, P = 0.914) and in all secondary endpoints. However, by week 48, trends favouring abatacept in %FVC, FVC (ml), %DLCO and SOBQ were observed without statistical significance. There was a significant improvement in pulmonary disease activity VAS and pre-post baseline slopes of %FVC and QIA scores in the a...