Abatacept for the treatment of myositis-associated interstitial lung disease

被引：1

作者：

Aggarwal, Rohit ^{[1
]}

Pongtarakulpanit, Nantakarn ^{[1
,2
]}

Sullivan, Daniel, I ^{[3
]}

Moghadam-Kia, Siamak ^{[1
]}

Bae, Sangmee Sharon ^{[4
]}

Wilkerson, Jesse ^{[5
]}

Saygin, Didem ^{[6
]}

Marder, Galina ^{[7
]}

Venuturupalli, Swamy ^{[8
]}

Dellaripa, Paul F. ^{[9
]}

Danoff, Sonye K. ^{[10
]}

Doyle, Tracy ^{[11
]}

Hunninghake, Gary M. ^{[11
]}

Lee, Joyce S. ^{[12
]}

Fischer, Aryeh ^{[13
]}

Falk, Jeremy ^{[14
]}

Johnson, Cheilonda ^{[15
]}

Koontz, Diane ^{[1
]}

Ascherman, Dana P. ^{[1
]}

Oddis, Chester, V ^{[1
]}

机构：

[1] Univ Pittsburgh, Dept Med, Div Rheumatol & Clin Immunol, Pittsburgh, PA USA

[2] Mahidol Univ, Ramathibodi Hosp, Dept Med, Div Allergy Immunol & Rheumatol, Bangkok, Thailand

[3] Univ Pittsburgh, Dept Med, Div Pulm Allergy Crit Care & Sleep Med, Pittsburgh, PA USA

[4] Univ Calif Los Angeles, Dept Med, Div Rheumatol, David Geffen Sch Med, Los Angeles, CA USA

[5] DLH LLC, Bethesda, MD USA

[6] Rush Univ, Div Rheumatol, Med Ctr, Chicago, IL USA

[7] Northwell Hlth, Dept Rheumatol, Great Neck, NY USA

[8] Cedars Sinai Med Ctr, Dept Med, Div Rheumatol, Beverly Hills, CA USA

[9] Brigham & Womens Hosp BWH, Dept Rheumatol, Boston, MA USA

[10] John Hopkins Med, Dept Med, Div Pulm & Crit Care Med, Baltimore, MD USA

[11] Brigham & Womens Hosp BWH, Div Pulm & Crit Care Med BWH, Boston, MA USA

[12] Univ Colorado Denver, Dept Med, Aurora, CO USA

[13] Bristol Myers Squibb, Lung Fibrosis Clin Dev Lead, Lawrenceville, NJ USA

[14] Cedars Sinai Med Ctr, Div Pulm & Crit Care, Los Angeles, CA USA

[15] Univ Penn, Dept Med, Philadelphia, PA USA

来源：

RHEUMATOLOGY | 2025年

关键词：

anti-synthetase syndrome; idiopathic inflammatory myopathy; interstitial lung disease; abatacept; randomized; placebo-controlled trial; IDIOPATHIC INFLAMMATORY MYOPATHIES; ANTISYNTHETASE SYNDROME; POLYMYOSITIS; STANDARDIZATION; DERMATOMYOSITIS; AUTOANTIBODIES; SPIROMETRY; PHENOTYPE; SEVERITY; SURVIVAL;

D O I：

10.1093/rheumatology/keaf218

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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

引用

页数：13

共 49 条

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