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March 28, 2026Transplantation and Cellular TherapyOpen Access

Transportability to the European population of Efficacy of Belumosudil as Compared with Physician’s Choice of Best Available Therapy for The Treatment of Chronic Graft Versus Host Disease

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Authors

DWDaniel WolffUniversity Hospital RegensburgCSCarlos SolanoUniversitat de ValènciaDMDavid Michonneau

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Implication

Transportability analysis shows potential efficacy of belumosudil in European cGVHD patients, indicating significant clinical benefits over BAT.

Key Points

  • This analysis aims to evaluate the efficacy of belumosudil in European patients with chronic graft-versus-host disease (cGVHD) by transporting US findings.
  • Conducted a transportability analysis to model belumosudil’s effect in EU patients.
  • Compared treatment responses from US patients with those in Europe using a targeted maximum likelihood estimation model.
  • Collected data from 196 US and 222 European patients treated with 2-5 prior lines of therapy between March 2015 and 2024.
  • Estimated overall response rate (ORR) for belumosudil in Europe was 37.6%, compared to 26.3% for best available therapy (BAT).
  • Found an ORR ratio of 1.427 with a p-value of 0.03, indicating significant efficacy.
  • Treatment-response patterns were similar in EU and US populations for cGVHD patients.

Cite This Study

Wolff et al. (2026) studied this question.

synapsesocial.com/papers/69c770f78bbfbc51511e0c98https://doi.org/10.1016/j.jtct.2026.03.028
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