Journal article
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
Transplantation, Vol.110(2), pp.e481-e491
02/2026
DOI: 10.1097/TP.0000000000005515
PMCID: PMC12818472
PMID: 41032890
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.
Details
- Title: Subtitle
- 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
- Creators
- Derek E Byers - Washington University in St. LouisRamsey Hachem - University of UtahChadi A Hage - University of PittsburghRajat WaliaHilary Goldberg - Brigham and Women's HospitalMrunal Patel - Indiana University – Purdue University IndianapolisJohn Reynolds - Duke UniversityJulia Klesney-Tait - University of IowaSelim Arcasoy - Columbia UniversityChetan Naik - Washington University in St. LouisNicoe De Simone - Carter BloodCareAmena Usmani - University of UtahReda Girgis - University of PittsburghFrancis Cordova - Washington University in St. LouisBrian Keller - Massachusetts General HospitalDavid Nunley - Indiana University – Purdue University IndianapolisJagadish Patil - University of MinnesotaMatthew Morrell - University of UtahHoward Huang - Methodist HospitalElizabeth Lendermon - University of Pittsburgh Medical CenterAmir Emtazoo - University of UtahAndres Pelaez - University of UtahKeith Wille - University of UtahKevin Chan - University of PittsburghGordon Yung - Dignity HealthMaher Baz - Brigham and Women's HospitalShambhu Aryal - Nova Medical (United States)Suresh Vedantham - University of UtahMary Clare Derfler - University of UtahPaul Commean - University of UtahKeith Berman - University of UtahAndrew Atkinson - University of PittsburghJeff Atkinson - Washington University in St. Louis School of MedicineAlexey Prokudin - Washington University in St. Louis School of MedicineJohn McCarthy - University of PittsburghGeorge J Despotis - Washington University in St. LouisEPI Study Group
- Resource Type
- Journal article
- Publication Details
- Transplantation, Vol.110(2), pp.e481-e491
- DOI
- 10.1097/TP.0000000000005515
- PMID
- 41032890
- PMCID
- PMC12818472
- NLM abbreviation
- Transplantation
- ISSN
- 1534-6080
- eISSN
- 1534-6080
- Publisher
- LIPPINCOTT WILLIAMS & WILKINS; PHILADELPHIA
- Grant note
- Centers for Medicare and Medicaid Services: CAG-00324R2 Therakos: NCT02181257
This study was funded by an investigator-initiated grant provided by Therakos LLC, a former Mallinckrodt Pharmaceuticals company (NCT02181257). The US Centers for Medicare and Medicaid Services (CMS) reimbursed costs of extracorporeal photopheresis therapy for enrolled participants in this CMS-approved study under its Coverage with Evidence Development authority (CAG-00324R2). J.M. is partially supported by National Science Foundation grant DMS 2054199.
- Language
- English
- Electronic publication date
- 09/24/2025
- Date published
- 02/2026
- Academic Unit
- Pulmonary, Critical Care, and Occupational Medicine; Internal Medicine
- Record Identifier
- 9984969108002771
Metrics
4 Record Views