Characterization of Spirometric Response to Standard-of-care Treatment in Lung Allograft Recipients With Bronchiolitis Obliterans and the Utility of Spirometric Criteria for Rescue Therapy: Implications for the Design of Risk-stratified Clinical Trials.

Authors

Derek E Byers, Ramsey Hachem, Chadi A Hage, Rajat Walia, Hilary Goldberg, Mrunal Patel, John Reynolds, Julia Klesney-Tait, Selim Arcasoy, Chetan Naik, Nicoe De Simone, Amena Usmani, Reda Girgis, Francis Cordova, Brian Keller, David Nunley, Jagadish Patil, Matthew Morrell, Elizabeth Lendermon, Howard Huang, Andres Pelaez, Amir Emtazoo, Keith Wille, Kevin Chan, Gordon Yung, Maher Baz, Shambhu Aryal, Suresh Vedantham, Mary Clare Derfler, Paul Commean, Keith Berman, Andrew Atkinson, Jeff Atkinson, Alexey Prokudin, John McCarthy, George J Despotis, on the behalf of the EPI Study Group

Published in

Transplantation. Sep 24, 2025. Epub Sep 24, 2025.

Abstract

The spirometric response to standard-of-care (SOC) immunosuppressive therapy for the management of bronchiolitis obliterans syndrome (BOS) has been sparsely reported in the literature. Data from a Medicare-approved Registry were analyzed to characterize the effectiveness/durability of a wide range of SOC interventions to manage the decline of lung function and to validate the study spirometric criteria for initiation of rescue therapy.
Lung transplant recipients with refractory BOS at 21 US collaborating centers were enrolled in the Registry. Data included both nonspirometric (eg, demographic, Immunosuppressive Regimens for management of BOS) and spirometric parameters (ie, FEV1 measurements and derived indices). The utility of study forced expiratory volume in 1 s (FEV1) criteria for treatment (ie, statistically significant rate of FEV1 decline >30 mL/mo) was evaluated by comparing the spirometric course between participants who met or did not meet this criterion.
Only 21% of participants treated with SOC therapy had >50% decrease (76 ± 25% decrease) in the rate of FEV1 decline. Although 51% of participants had a partial response (rate of FEV1 decline decreased on average 71%), 49% of participants had a substantial increase (mean increase 224%). The FEV1 criterion for treatment was able to identify 19% of participants (48/258) who achieved durable stabilization (ie, nonsignificant rate of FEV1 <30 mL/mo) with SOC therapy.
Patients with BOS have a widely variable response to SOC therapy. Our findings support the use of FEV1 rate of decline to assess response to SOC therapy and to assure appropriate assignment of participants with refractory BOS to rescue therapy treatment cohorts.

PMID:
41032890
Bibliographic data and abstract were imported from PubMed on 02 Oct 2025.

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