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Real-world outcomes in refractory chronic graft-versus-host disease: the Italian multicenter experience with

Francesca Bonifazi1, Marcello Roberto2, Maria Teresa Lupo Stanghellini3

  • 1IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia 'Seràgnoli', Bologna. francesca.bonifazi@unibo.it.

Haematologica
|February 19, 2026
PubMed

Insights

Belumosudil effectively treats chronic graft-versus-host disease (cGvHD) in heavily pretreated patients. This real-world study shows significant response rates and improved patient outcomes, confirming its role in refractory cGvHD.

Area of Science:

  • Hematology
  • Immunology
  • Pharmacology

Background:

  • Chronic graft-versus-host disease (cGvHD) is a significant complication of allogeneic hematopoietic stem cell transplantation, impacting quality of life and survival.
  • Existing treatments for steroid-refractory or -dependent cGvHD are limited, necessitating novel therapeutic approaches.

Purpose of the Study:

  • To evaluate the real-world effectiveness and tolerability of belumosudil, a ROCK2 inhibitor, in patients with chronic graft-versus-host disease (cGvHD).

Main Methods:

  • A retrospective, multicenter study involving 80 patients with cGvHD treated with belumosudil across 29 Italian centers.
  • Analysis of best overall response rate (ORR), overall response rates at 3, 6, and 12 months, time to response, duration of response, failure-free survival, and patient-reported outcomes using the NIH Severity Index Score.

Main Results:

  • The best overall response rate was 62.5%, with ORRs of 52.6%, 57.6%, and 55.0% at 3, 6, and 12 months, respectively.
  • Median time to response was 3 months, with an 83.4% 12-month duration of response and 67.5% 12-month failure-free survival.
  • Meaningful improvements in patient-reported outcomes were observed, and treatment was generally well tolerated across all involved organs.

Conclusions:

  • Belumosudil demonstrates significant efficacy in a real-world setting for patients with cGvHD refractory to multiple immunosuppressive therapies.
  • These findings support belumosudil as a valuable therapeutic option for managing steroid-refractory or -dependent cGvHD.
  • The study highlights the potential of ROCK2 inhibition in addressing the unmet needs in cGvHD management.

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