Ruxolitinib plus Steroids for Acute Graft Versus Host Disease
A Multicenter, Randomized, Phase 3 Trial
In patients newly diagnosed with high-risk acute graft-versus-host disease (aGVHD), clinical outcomes have historically been poor. This study evaluates combining ruxolitinib (RUX) with corticosteroids against using corticosteroids alone.
Study Overview
This phase 3 trial (ClinicalTrials.gov: NCT04061876) tested the safety and effectiveness of:
- Ruxolitinib with steroids: RUX at 5 mg/day combined with methylprednisolone at 1 mg/kg/day.
- Steroids only: Methylprednisolone at 2 mg/kg/day alone.
The trial included 198 patients diagnosed with intermediate or high-risk aGVHD. They were randomly divided into two groups:
- 99 patients: Received RUX + steroids.
- 99 patients: Received steroids only.
Key Findings
- Response Rate: On day 28, 92.9% of the RUX/steroids group showed improvement compared to 70.7% in the steroids-only group.
- Long-term Outcomes: After 18 months, 57.2% of the RUX/steroids group remained free from failure, compared to 33.3% in the steroids-only group.
- Adverse Events: There were fewer severe adverse events in the RUX/steroids group (26.3%) versus the steroids-only group (50.5%).
This trial is the first of its kind to confirm that adding ruxolitinib is both effective and safe for treating newly diagnosed high-risk aGVHD.
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