What type of study is this?

This is a Human Clinical Trial study (also classified as: Pre-Registered Trial).

December 8, 2025Blood

Safety analysis of axatilimab in patients with chronic graft-versus-host disease in an expanded access program

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Authors

ASAnthony S. Stein HCHannah Choe

Discussion

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Overview

Safety analysis reports adverse events in chronic graft-versus-host disease patients receiving axatilimab, indicating its tolerability after systemic therapy failure.

Key Points

To analyze the safety of axatilimab in patients with chronic graft-versus-host disease through an expanded access program.
Open-label, multicenter study design
Included patients with active, refractory cGVHD aged ≥6 years
Documented disease history and concurrent treatments
Evaluated adverse events from consent to 30 days post-treatment
Used descriptive statistics to summarize data
112 patients enrolled, 104 received axatilimab
41.3% reported serious adverse events, most commonly hypoxia and pneumonia
72.1% experienced any treatment-emergent adverse events
Only 5 patients discontinued due to unacceptable toxicity
Majority transitioned to commercial product, suggesting ongoing clinical benefit

Cite This Study

Stein et al. (2025) studied this question.

synapsesocial.com/papers/693624dd4fa91c937236d19a https://doi.org/10.1182/blood-2025-6008

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December 8, 2025Blood

Safety analysis of axatilimab in patients with chronic graft-versus-host disease in an expanded access program

View Full Paper

Ask AI

Bookmark

Authors

ASAnthony S. Stein HCHannah Choe

Discussion

Member takes

Overview

Safety analysis reports adverse events in chronic graft-versus-host disease patients receiving axatilimab, indicating its tolerability after systemic therapy failure.

Key Points

To analyze the safety of axatilimab in patients with chronic graft-versus-host disease through an expanded access program.
Open-label, multicenter study design
Included patients with active, refractory cGVHD aged ≥6 years
Documented disease history and concurrent treatments
Evaluated adverse events from consent to 30 days post-treatment
Used descriptive statistics to summarize data
112 patients enrolled, 104 received axatilimab
41.3% reported serious adverse events, most commonly hypoxia and pneumonia
72.1% experienced any treatment-emergent adverse events
Only 5 patients discontinued due to unacceptable toxicity
Majority transitioned to commercial product, suggesting ongoing clinical benefit

Cite This Study

Stein et al. (2025) studied this question.

synapsesocial.com/papers/693624dd4fa91c937236d19a https://doi.org/10.1182/blood-2025-6008

View Full Paper

Ask AI

Bookmark