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December 8, 2025BloodOpen Access

Axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic graft-versus-host disease: Interim safety analysis of a phase 2, randomized study

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Authors

RZRobert ZeiserAIAnnie ImAAAlbert Assad

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Overview

Interim analysis shows axatilimab plus ruxolitinib is well tolerated in patients with chronic graft-versus-host disease, indicating improved safety profile.

Key Points

  • To evaluate the interim safety of axatilimab in combination with ruxolitinib in chronic graft-versus-host disease patients.
  • Randomized, open-label, multicenter phase 2 study enrolled patients aged ≥12 with newly diagnosed cGVHD
  • Patients received either axatilimab plus ruxolitinib, ruxolitinib alone, or corticosteroids
  • Safety assessed through treatment-emergent adverse events and laboratory evaluations
  • 44 patients enrolled and treated, with 43 having received study treatment
  • No evidence of additive toxicity with the axatilimab and ruxolitinib combination
  • Common treatment-emergent adverse events included diarrhea, fatigue, and increased amylase

Cite This Study

Zeiser et al. (2025) studied this question.

synapsesocial.com/papers/693624dd4fa91c937236d199https://doi.org/10.1182/blood-2025-6012
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Safety analysis of axatilimab in patients with chronic graft-versus-host disease in an expanded access program2025 · 1 citations
  2. 2An open-label phase I study of JAK inhibitor ruxolitinib with and without CTLA-4 ig abatacept for the prophylaxis of graft-versus-host ddsease and cytokine release syndrome after T-cell replete haploidentical peripheral blood hematopoietic cell transplantation2025
  3. 3Predictors of response and safety profile of axatilimab in chronic GVHD: Pooled analysis of 384 patients.2026
  4. 4Long-term treatment duration and safety of axatilimab among patients with chronic graft-versus-host disease in AGAVE-2012025 · 1 citations
  5. 5Impact of ruxolitinib on corticosteroid treatment patterns in 1147 patients with chronic graft-versus-host disease in real-world practice in the United States: A long-term follow-up analysis2025