Aggarwal R.Pongtarakulpanit N.Sullivan D.I.Moghadam-Kia S.Bae S.S.Wilkerson J.Saygin D.Marder G.Venuturupalli S.Dellaripa P.F.Danoff S.K.Doyle T.Hunninghake G.M.Lee J.S.Fischer A.Falk J.Johnson C.Koontz D.Ascherman D.P.Oddis C.V.Mahidol University2025-12-182025-12-182025-12-01Rheumatology Vol.64 No.SI (2025) , SI156-SI16814620324https://repository.li.mahidol.ac.th/handle/123456789/113569Objectives 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 24weeks, 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 abatacept arm. Abatacept was generally well tolerated. Conclusion Abatacept did not significantly improve %FVC at 24weeks. However, trends at 48weeks suggest potential benefits, supporting the need for a larger, long-term randomized controlled trial.MedicineArticleSCOPUS10.1093/rheumatology/keaf2182-s2.0-1050244505711462033240272902