Abatacept for the treatment of myositis-associated interstitial lung disease (ATtackMy-ILD).

作者信息

Aggarwal Rohit, Pongtarakulpanit Nantakarn, Sullivan Daniel I, Moghadam-Kia Siamak, Bae Sangmee Sharon, Wilkerson Jesse, Saygin Didem, Marder Galina, Venuturupalli Swamy, Dellaripa Paul F, Danoff Sonye K, Doyle Tracy, Hunninghake Gary M, Lee Joyce S, Fischer Aryeh, Falk Jeremy, Johnson Cheilonda, Koontz Diane, Ascherman Dana P, Oddis Chester V

机构信息

Department of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, United States of America.

Department of Medicine, Division of Allergy, Immunology and Rheumatology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Rheumatology (Oxford). 2025 Apr 24. doi: 10.1093/rheumatology/keaf218.

DOI:10.1093/rheumatology/keaf218

PMID:40272902

Abstract

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 end point 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 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 was analyzed 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 end point of %FVC change between abatacept and placebo (between treatment difference of -0.35, 95%CI -6.91-6.21, p= 0.914) and in all secondary endpoints. However, by week 48, trends favoring 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 abatacept arm. Abatacept was generally well tolerated.

CONCLUSION

Abatacept did not significantly improve %FVC at 24 weeks. However, trends at 48 weeks suggest potential benefits, supporting the need for a larger, long-term randomized controlled trial.