IDENTIFICATION AND DESCRIPTION OF CHRONIC GRAFT-VERSUS-HOST DISEASE PATIENTS USING TRINETX LIVE PLATFORM
Author(s)
Sandrine Colas1, Julie Nhu Ha, PharmD2, Rihab Gamaoun, PharmD3, Marie-Laure Kürzinger, MSc3.
1Pharmacoepidemiologist, Sanofi, Paris, France, 2Patient Safety and PharmacoVigilance, Sanofi, Toronto, ON, Canada, 3Patient Safety and PharmacoVigilance, Sanofi, Gentilly, France.
1Pharmacoepidemiologist, Sanofi, Paris, France, 2Patient Safety and PharmacoVigilance, Sanofi, Toronto, ON, Canada, 3Patient Safety and PharmacoVigilance, Sanofi, Gentilly, France.
OBJECTIVES: Chronic graft versus host disease (cGVHD) is the most common, severe complication of allogeneic hematopoietic stem cell transplant (allo-HSCT), affecting ~30-50% recipients. This multi-organ autoimmune disease impacts quality of life and contributes to non-relapse mortality. Yet limited literature describes this population.Objectives were to i) identify cGVHD patients and describe their characteristics, organ involvement, and treatment patterns, ii) estimate safety events incidences using TriNetX Global Network.
METHODS: Patients aged ≥12 years with allo-HSCT and cGVHD (ICD-10) between Jan2021-Dec2025 were identified in TriNetX. Indication for allo-HST, demographics at cGVHD onset and agents by line of therapy (LOT) were described. Cumulative incidences of safety events (liver disease, pneumonia, sepsis, cytopenia, secondary malignancies) were estimated.
RESULTS: Among 6,840 cGVHD patients identified, 57% were male. Blood cancer history included myeloid leukemia (55%), lymphoid leukemia (25%), myelodysplastic syndromes (23%), lymphomas (21%), multiple myeloma (7%). Mean age at cGVHD was 52.8±17 years. Comorbidities were heart disease (42%), kidney disease (35%), liver disease (19%).
Affected organs at baseline/last follow-up were (up to 5 years): lungs (25%/64%), digestive system (30%/65%), muscles/connective tissue (25%/68%), genitourinary system (23%/58%), skin (17%/52%), mouth (7%/25%), liver (6%/20%).
Systemic corticosteroids dominated 1st LOT (52%), dropping in subsequent LOTs (<32% in LOT6). Corticosteroids+calcineurin inhibitors peaked in 2nd LOT (12%). Corticosteroids+ruxolitinib increased from early to later LOTs (2% to <6%). Ruxolitinib was prescribed in 49.24% during first four LOTs. Belumosudil use increased from 3rd-6th LOT (4%-6%).
Safety events cumulative incidences were: thrombocytopenia 35.3%; severe infections 35.5%; pneumonia 29.8%; liver disease 25.1%; secondary malignancies 2.6%.
CONCLUSIONS: This TriNetX study provides valuable real-world insights on cGVHD patients and safety. Patient characteristics and treatment pathways align with previous multicentric French studies and reflect adherence to recent guidelines.
METHODS: Patients aged ≥12 years with allo-HSCT and cGVHD (ICD-10) between Jan2021-Dec2025 were identified in TriNetX. Indication for allo-HST, demographics at cGVHD onset and agents by line of therapy (LOT) were described. Cumulative incidences of safety events (liver disease, pneumonia, sepsis, cytopenia, secondary malignancies) were estimated.
RESULTS: Among 6,840 cGVHD patients identified, 57% were male. Blood cancer history included myeloid leukemia (55%), lymphoid leukemia (25%), myelodysplastic syndromes (23%), lymphomas (21%), multiple myeloma (7%). Mean age at cGVHD was 52.8±17 years. Comorbidities were heart disease (42%), kidney disease (35%), liver disease (19%).
Affected organs at baseline/last follow-up were (up to 5 years): lungs (25%/64%), digestive system (30%/65%), muscles/connective tissue (25%/68%), genitourinary system (23%/58%), skin (17%/52%), mouth (7%/25%), liver (6%/20%).
Systemic corticosteroids dominated 1st LOT (52%), dropping in subsequent LOTs (<32% in LOT6). Corticosteroids+calcineurin inhibitors peaked in 2nd LOT (12%). Corticosteroids+ruxolitinib increased from early to later LOTs (2% to <6%). Ruxolitinib was prescribed in 49.24% during first four LOTs. Belumosudil use increased from 3rd-6th LOT (4%-6%).
Safety events cumulative incidences were: thrombocytopenia 35.3%; severe infections 35.5%; pneumonia 29.8%; liver disease 25.1%; secondary malignancies 2.6%.
CONCLUSIONS: This TriNetX study provides valuable real-world insights on cGVHD patients and safety. Patient characteristics and treatment pathways align with previous multicentric French studies and reflect adherence to recent guidelines.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH190
Topic
Epidemiology & Public Health, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Oncology, Rare & Orphan Diseases