Rheumatology (Oxford, England) · 2025
Abatacept for the treatment of myositis-associated interstitial lung disease.
Клиническое исследование II фазыСтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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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
Аннотация
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.
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.