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December 19, 2025Clinical Pharmacology & TherapeuticsOpen Access

Axatilimab Immunogenicity and Clinical Relevance in Patients with Chronic Graft‐Versus‐Host Disease

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Authors

YYYan‐ou YangXLXing LiuBBBreann Barker

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Overview

Clinical trial examines the effects of immunogenicity on efficacy and safety of axatilimab in chronic graft-versus-host disease patients, indicating minimal impact of ADA and NAb.

Key Points

  • To evaluate the effects of antidrug antibodies on the pharmacokinetics, pharmacodynamics, efficacy, and safety of axatilimab in patients with cGVHD.
  • Analyzed data from 319 participants with chronic graft-versus-host disease (cGVHD) including those with treatment-emergent ADA.
  • Measured pharmacokinetics and pharmacodynamics based on ADA status and neutralizing antibody (NAb) occurrence.
  • Examined overall response rates and safety events across different ADA and NAb subgroups.
  • 34.2% of participants were treatment-emergent ADA-positive, with most onset within the first month.
  • No significant differences in pharmacokinetics, efficacy, or safety were found between ADA and NAb subgroups.
  • Remained consistent nonclassical monocyte levels regardless of ADA or NAb status.

Cite This Study

Yang et al. (2025) studied this question.

synapsesocial.com/papers/69449a892f0218eca95083aehttps://doi.org/10.1002/cpt.70161
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Also Consider

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

  1. 1Predictors of response and safety profile of axatilimab in chronic GVHD: Pooled analysis of 384 patients.2026
  2. 2Axatilimab (Niktimvo®) in chronic graft-versus-host disease: a profile of its use2026
  3. 3Safety analysis of axatilimab in patients with chronic graft-versus-host disease in an expanded access program2025 · 1 citations
  4. 4An evaluation of axatilimab for the treatment of chronic graft-versus-host disease2026
  5. 5Axatilimab in Recurrent or Refractory Chronic Graft-versus-Host Disease2024 · 151 citations