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Clinical Trial
. 2025 Dec 1;64(SI):SI156-SI168.
doi: 10.1093/rheumatology/keaf218.

Abatacept for the treatment of myositis-associated interstitial lung disease

Rohit Aggarwal  1 , Nantakarn Pongtarakulpanit  1   2 , Daniel I Sullivan  3 , Siamak Moghadam-Kia  1 , Sangmee Sharon Bae  4 , Jesse Wilkerson  5 , Didem Saygin  6 , Galina Marder  7 , Swamy Venuturupalli  8 , Paul F Dellaripa  9 , Sonye K Danoff  10 , Tracy Doyle  11 , Gary M Hunninghake  11 , Joyce S Lee  12 , Aryeh Fischer  13 , Jeremy Falk  14 , Cheilonda Johnson  15 , Diane Koontz  1 , Dana P Ascherman  1 , Chester V Oddis  1
Affiliations
Clinical Trial

Abatacept for the treatment of myositis-associated interstitial lung disease

Rohit Aggarwal et al. Rheumatology (Oxford). .

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 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 24 weeks. However, trends at 48 weeks suggest potential benefits, supporting the need for a larger, long-term randomized controlled trial.

Clinical trial registration: clinicaltrials.gov; NCT03215927.

Keywords: abatacept; anti-synthetase syndrome; idiopathic inflammatory myopathy; interstitial lung disease; placebo-controlled trial; randomized.

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References

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