MORTALITY BY ORGAN-SPECIFIC FIBROTIC MANIFESTATIONS IN PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE IN THE UNITED STATES
6 affiliations
- 1Department of Pharmaceutical Services, Winship Cancer Institute of Emory University, Atlanta, United States
- 2Sanofi, Morristown, United States
- 3Sanofi, Berlin, Germany
- 4Nference Inc, Bengaluru, Karnataka - India
- 5Nference Inc, Cambridge, United States
- 6Sanofi, São Paulo, SP, Brazil
Abstract
Background: Fibrotic manifestations of cGVHD can affect multiple organs including lung, skin, gastrointestinal tract, and joint/fascia, leading to significant morbidity and mortality; however, the real-world impact of organ-specific fibrotic manifestations on mortality has not been well characterized. This study evaluated the impact of organ-specific fibrosis on all-cause mortality. Methods: Patient electronic medical records deidentified in a HIPAA-compliant manner from a multisite academic medical center in the US were analyzed to identify adults (aged ≥ 18 years) with first allogenic hematopoietic stem cell transplantation (aHSCT) and cGVHD diagnosis between 1 January 2015 and 31 May 2024. A large language model (LLM) with tailored prompts was leveraged to identify lung, skin, gastrointestinal (GI), and joint/fascia fibrosis from unstructured patient notes using predefined fibrosis-suggestive and -specific terms developed with clinical expert input. Fibrosis presence was assessed from 90 days before through the day of their first identified cGVHD diagnosis in the health care system (baseline) and post-cGVHD diagnosis (follow-up). Landmark analyses at 1-year post-cGVHD diagnosis evaluated the impact of fibrosis on all-cause mortality. Differences in overall survival were assessed by Cox hazard regression and the log-rank test. Results: Of 925 patients meeting inclusion criteria, median age at diagnosis was 60 years, 91% were White, 57% male, with acute myeloid leukemia (34%) and myelodysplastic syndrome (23%) being most common pre-transplant diagnoses. Mean follow-up was 33.1 months. Overall, 49% of patients had evidence of selected fibrosis at some point in their medical record with fibrosis of skin being the most common (31%) followed by fibrosis of lung (17%), joint and fascia (16%) and GI (5%). Of 674 patients alive and contributing data at 1-year landmark timepoint, 259 patients had evidence of fibrosis. Patients with fibrosis at one-year landmark had more severe cGVHD at baseline (30% vs 19%) and were prescribed more systematic treatments compared to patients with no fibrosis including ruxolitinb and ECP. Whilst median survival was not reached for landmark cohort, survival at 36 month was lower for those with lung fibrosis compared to those without fibrosis at landmark (77.6% vs 89.7%, p-value 0.039) corresponding to a hazard ratio of 1.72 (95% CI 1.02-2.90). Conclusions: This real-world evidence study demonstrates that fibrotic manifestations in cGVHD are prevalent. Those developing lung fibrosis had lower overall survival compared to patients without. These findings support the need for early identification and intervention.
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BibTeX
@article{hall2026mortality,
title = {{MORTALITY BY ORGAN-SPECIFIC FIBROTIC MANIFESTATIONS IN PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE IN THE UNITED STATES}},
author = {Kevin HALL and Lauren ROTA and Shaum KABADI and Kathy MARSHALL and Robert SCHWENK and Nataly BLEIBDREY and Mithun MANOHARAN and Allison SMITHER and Alyshah Abdul SULTAN and Luiz SANTORO NETO},
journal = {Hematology, Transfusion and Cell Therapy},
year = {2026},
month = oct,
doi = {10.1016/j.htct.2026.106892},
url = {https://doi.org/10.1016/j.htct.2026.106892},
note = {CC BY},
}
RIS
TY - JOUR
TI - MORTALITY BY ORGAN-SPECIFIC FIBROTIC MANIFESTATIONS IN PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE IN THE UNITED STATES
AU - Kevin HALL
AU - Lauren ROTA
AU - Shaum KABADI
AU - Kathy MARSHALL
AU - Robert SCHWENK
AU - Nataly BLEIBDREY
AU - Mithun MANOHARAN
AU - Allison SMITHER
AU - Alyshah Abdul SULTAN
AU - Luiz SANTORO NETO
PY - 2026
DA - 2026/10/23
JO - Hematology, Transfusion and Cell Therapy
DO - 10.1016/j.htct.2026.106892
UR - https://doi.org/10.1016/j.htct.2026.106892
AB - Background: Fibrotic manifestations of cGVHD can affect multiple organs including lung, skin, gastrointestinal tract, and joint/fascia, leading to significant morbidity and mortality; however, the real-world impact of organ-specific fibrotic manifestations on mortality has not been well characterized. This study evaluated the impact of organ-specific fibrosis on all-cause mortality. Methods: Patient electronic medical records deidentified in a HIPAA-compliant manner from a multisite academic medical center in the US were analyzed to identify adults (aged ≥ 18 years) with first allogenic hematopoietic stem cell transplantation (aHSCT) and cGVHD diagnosis between 1 January 2015 and 31 May 2024. A large language model (LLM) with tailored prompts was leveraged to identify lung, skin, gastrointestinal (GI), and joint/fascia fibrosis from unstructured patient notes using predefined fibrosis-suggestive and -specific terms developed with clinical expert input. Fibrosis presence was assessed from 90 days before through the day of their first identified cGVHD diagnosis in the health care system (baseline) and post-cGVHD diagnosis (follow-up). Landmark analyses at 1-year post-cGVHD diagnosis evaluated the impact of fibrosis on all-cause mortality. Differences in overall survival were assessed by Cox hazard regression and the log-rank test. Results: Of 925 patients meeting inclusion criteria, median age at diagnosis was 60 years, 91% were White, 57% male, with acute myeloid leukemia (34%) and myelodysplastic syndrome (23%) being most common pre-transplant diagnoses. Mean follow-up was 33.1 months. Overall, 49% of patients had evidence of selected fibrosis at some point in their medical record with fibrosis of skin being the most common (31%) followed by fibrosis of lung (17%), joint and fascia (16%) and GI (5%). Of 674 patients alive and contributing data at 1-year landmark timepoint, 259 patients had evidence of fibrosis. Patients with fibrosis at one-year landmark had more severe cGVHD at baseline (30% vs 19%) and were prescribed more systematic treatments compared to patients with no fibrosis including ruxolitinb and ECP. Whilst median survival was not reached for landmark cohort, survival at 36 month was lower for those with lung fibrosis compared to those without fibrosis at landmark (77.6% vs 89.7%, p-value 0.039) corresponding to a hazard ratio of 1.72 (95% CI 1.02-2.90). Conclusions: This real-world evidence study demonstrates that fibrotic manifestations in cGVHD are prevalent. Those developing lung fibrosis had lower overall survival compared to patients without. These findings support the need for early identification and intervention.
SN - 2531-1379
SN - 2531-1387
ER -