Use of Race-Specific Equations in Pulmonary Function Tests Impedes Potential Eligibility for Care and Treatment of Pulmonary Fibrosis.

RATIONALE: The use of race-specific reference values to evaluate pulmonary function has long been embedded into clinical practice; however, there is a growing consensus that this practice may be inappropriate and that use of race-neutral equations should be adopted to improve access to healthcare.

OBJECTIVES: To evaluate if using race-neutral equations to assess percent predicted forced vital capacity (FVC%pred) impacts eligibility for clinical trials, antifibrotic therapy and referral for lung transplantation in Black, Hispanic/Latino, and White patients with interstitial lung disease (ILD) Methods: FVC%pred values for patients from the Pulmonary Fibrosis Foundation Patient Registry were calculated using race-specific (Hankinson 1999), race-agnostic (Global Lung Function Initiative [GLI]-2012), and race-neutral (GLI-2022 or GLI-Global) equations. Eligibility for ILD clinical trials (FVC%pred >45% and <90%), antifibrotic therapy (FVC%pred >55% and <82%), and lung transplantation referral (FVC%pred <70%) using GLI-2022 and GLI-2012 were compared with that of Hankinson 1999.

RESULTS: Baseline characteristics were available for 1882 patients (Black, n=104; Hispanic/Latino, n=103; White, n=1675), and outcomes were evaluated in 1531 patients with FVC%pred within ±90 days of Registry enrollment (Black, n=78; Hispanic/Latino, n=72; White, n=1381). Black patients were younger at consent and more likely to be female than Hispanic/Latino or White patients. Compared with GLI-2022, Hankinson's 1999 criteria misclassified 22% of Black patients, 14% of Hispanic/Latino patients, and 12% of White patients for ILD clinical trial eligibility; misclassified 21% of Black patients, 17% of Hispanic/Latino patients, and 19% of White patients for antifibrotic therapy eligibility; and misclassified 6% of Black patients, 14% of Hispanic/Latino patients, and 12% of White patients for lung transplantation referral. Similar trends were observed when comparing GLI-2012 with Hankinson 1999.

CONCLUSIONS: Misclassification of patients for critical interventions is highly prevalent when using Hankinson's 1999 criteria and highlights the need to consider adopting the race-neutral GLI-2022 for enhanced accuracy and more equitable representation in pulmonary healthcare. Our results make a compelling case for re-evaluating the use of race as a physiological variable and emphasize the pressing need for continuous innovation to ensure equal and optimal care for all patients, regardless of their race or ethnicity.

CLINICAL TRIAL REGISTRATION: NCT02758808 Primary source of funding: This analysis was sponsored by F. Hoffmann-La Roche, Ltd./Genentech, Inc.