Baseline characteristics of the TRANSLATE2 cohort: A prospective study on rheumatoid arthritis-associated interstitial lung disease

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OBJECTIVES: To describe the baseline characteristics of patients enrolled in the TRANSLATE2 cohort (NCT04227535), a national, multicenter, prospective case-control study designed to investigate the genetic and non-genetic determinants of interstitial lung disease (ILD) in rheumatoid arthritis (RA). METHODS: Cases with RA-ILD and RA controls without ILD were consecutively included in TRANSLATE2 with a 5-year prospective follow-up. All participants fulfilled the ACR/EULAR 2010 classification criteria for RA. ILD presence or absence was confirmed for every participant by chest high-resolution computed tomography (HRCT). Baseline demographic and clinical data were collected. Blood samples were collected at enrollment for centralized biobanking of DNA, RNA, and serum to support future genetic and biomarker studies. For ILD cases, chest HRCT scans were centrally reviewed to determine HRCT pattern. For the current study, associations with ILD were tested using univariable and multivariable logistic regression models. RESULTS: Among the 506 patients included (275 RA-ILD, 231 RA-noILD), RA-ILD cases were more frequently male (48.4% vs. 29.9%), older at enrollment (66.6 [9.9] vs. 58.5 [13.2] years) and older at RA onset (52.2 [14.7] vs. 45.8 [14.3] years). ILD was independently associated with male sex (OR 1.82; 95% CI 1.06, 3.14) and older age at RA onset (OR per 10 years 1.28; 95% CI 1.10,1.50). For ILD cases, the most frequent HRCT patterns were definite for usual interstitial pneumonia (39.3%) and non-specific interstitial pneumonia (17.8%). At enrollment, respiratory symptoms were observed in 67.3% with a mean forced vital capacity % predicted of 87.6% (21.7) and a mean diffusing capacity of the lung for carbon monoxide % predicted of 58.4% (18.8). CONCLUSION: The TRANSLATE2 cohort provides a comprehensive and deeply phenotyped dataset that offers a unique opportunity to investigate the genetic architecture, risk factors, and natural history of RA-ILD.

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