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  1. Article
  2. Source: Campus Sanofi
  3. May 20, 2025

Clinical outcomes of cGvHD following allogeneic HSCT: A Swedish population-based real-world registry study

Author: Sanofi

Editorial Team

   

KEY TAKEAWAY

This population-based real-world registry study analyzed clinical outcomes of cGvHD among patients who underwent allogeneic HSCT in Sweden.

  • Among patients surviving ≥6 months post-HSCT, cGvHD incidence was 71.9%
  • At 1-year post-HSCT, non-cGvHD patients had 4.72 times higher mortality risk compared to those with moderate-severe cGvHD (P <0.0001)
  • Patients with moderate-severe cGvHD had higher rates of morbidities (P <0.05) and healthcare utilization (~1.6-fold) vs non- and mild cGvHD
  • The study findings emphasize the need for novel treatments and real-time methods to monitor effective immunosuppression following HSCT

WHY THIS MATTERS

cGvHD is a serious immune-mediated complication of HSCT but is associated with superior survival in patients with hematological malignancies.

  • Hence, a major challenge in managing cGvHD is to optimize prevention of severe disease while maximizing the graft-versus-leukemia effect

There is limited data on cGvHD burden from real-world studies

  • cGvHD disease burden and associated clinical outcomes have not been adequately assessed in Sweden
  • Hence, this study evaluated cGvHD disease burden (mortality and morbidities) and associated healthcare resource utilization in Sweden

STUDY DESIGN

  • Retrospective, population-based longitudinal study using 4 national registers*
  • All patients with a record of allogeneic HSCT from 2006 to 2015 were identified in the Patient Register
  • Exclusion criteria: Absence of hematological malignancy prior HSCT; reused proxy identification numbers; age <18 or >75; death ≤6 months post-HSCT
  • The 0–6-month follow-up period for patients who survived ≥6 months (index date) was 6–12 months post-HSCT
  • Based on the timing and extent of commonly used cGvHD treatments, patients were classified as having non-, mild, or moderate-severe cGvHD†
  • Statistical analysis‡: OS rates by Kaplan-Meier method and difference among groups by log-rank/Mantel–Haenszel test; time-dependent HRs by multi-variate Cox-regression model; adjusted morbidity incidence rate ratios (IRR) by multivariate negative binomial model
    • For each follow-up year, rate of healthcare resource utilization was calculated as the total number of days in inpatient/outpatient care reported in the Patient Register for all causes divided by the total days contributed to follow-up time for that follow-up year

KEY RESULTS

Patient characteristics

  • Of 1,246 included patients, 28.1% were classified as non-cGvHD and 71.9% as cGvHD (mild cGvHD, 27.7%; moderate-severe cGvHD, 44.2%).
  • Sex (58% men), age (median, 52 [40–61] years), year of HSCT (2011–2015, 65%; 2006–2010, 35%), and source for HSCT (peripheral blood stem cells, 76%; bone marrow/cord blood, 24%) were comparable across cohorts.
  • Diagnosis of acute leukemia was more common in non-cGvHD patients (63%) vs those with moderate-severe cGvHD (51%) and mild cGvHD (52%).

Overall survival

  • At 1-year post-HSCT:
    • OS decreased with decreasing cGvHD severity status
    • Best OS was in patients with moderate-severe cGvHD
    • Lowest OS rate was in non-cGvHD patients, mainly due to relapse-related mortality (RRM)
  • At 5-year follow-up:
    • OS was similar among the 3 groups
    • During the entire follow-up period, OS did not significantly differ among the groups (P = 0.73)
  • More patients died from RRM than transplant-related mortality in all groups.
OS rateaNon-cGvHD
(n = 350)		Mild cGvHD
(n = 345)		Moderate-Severe
cGvHD (n = 551)		P-valueb
1-year OS rate, %74.382.087.5<0.0001
5-year OS rate, %67.763.365.30.5

aOS rate by Kaplan-Meier method; bDifference among groups by log-rank/Mantel–Haenszel test.

Mortality

  • During the follow-up period, the risk of mortality was significantly higher in non- and mild cGvHD patients than in those with moderate-severe cGvHD.
  • Factors such as HSCT treatment period, sex, or donor relationship did not have an impact on the risk of mortality (P >0.05).
  • Patients aged 60–75 years who underwent HSCT had increased risk of mortality vs those aged 18–39 years.
  • Patients who received peripheral blood stem cells had reduced risk of mortality vs those who received bone marrow or cord blood as donor source.
 Multivariate analysis
HR (95% CI)		P-valuea
(multivariate)
cGvHD  
Non-cGvHD vs moderate-severe cGvHD4.72 (3.07–7.24)<0.0001
Mild cGvHD vs moderate-severe cGvHD2.21 (1.37–3.56)0.001
Age at follow-up, years  
60–75 vs 18–391.47 (1.14–1.91)0.004
Source for HSCT  
PBSC vs bone marrow/cord blood0.77 (0.63–0.95)0.016

aP-value produced using a univariate and multivariate Cox-regression model, respectively.

Morbidities

  • During the follow-up period, the risk of mortality was significantly hIncidence of most morbidities was significantly higher (P <0.05) among patients with moderate-severe cGvHD vs those with non- (21–83% higher IRRs) and mild cGvHD (10–77% higher IRRs).

Healthcare resource utilization‡
 

  • During the 10-year study period, number of transplants more than doubled, but the proportion of patients with cGvHD remained approximately constant.
  • In the follow-up period, more moderate-severe cGvHD patients received inpatient or outpatient healthcare after HSCT vs non- or mild cGvHD patients.
  • At 1-year follow-up, the proportion of patients with moderate-severe cGvHD using healthcare was ~1.6-fold higher vs those with non- or mild cGvHD.
  • Compared to non- and mild cGvHD patients, those with moderate-severe cGvHD spent larger proportion of follow-up time in:
    • Inpatient healthcare (59% and 31% more, respectively)
    • Outpatient healthcare (54% and 36% more, respectively)

*Four national population-based registers held by the National Board of Health and Welfare were linked: The Patient Register, the Cancer Register, the Cause of Death Register, and the Prescribed Drug Register.
†non-cGvHD, patients who received neither systemic corticosteroids nor systemic immunosuppressive treatment during the entire observation period after tapering of post-HSCT GvHD prophylaxis immuno-suppression; mild cG- vHD, patients receiving either corticosteroids or immunosuppressants alone; moderate-severe cGvHD, patients re- quiring more intensive treatment than those with mild cGvHD. ‡Patients who did not survive ≥6 months post-HSCT (n = 193) were excluded.

Please refer to the source publication Novitzky-Basso I, et al. for additional details.

MAT-KW-2400453/V1/Dec2024  

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