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Ruxolitinib plus corticosteroids in newly diagnosed patients with aGvHD: Results from a phase III trial
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Standard initial therapy for patients with aGvHD typically consists of corticosteroids, such as methylprednisolone or prednisolone.1 A multicenter, open-label, randomized phase III trial (NCT04061876) assessed the safety and effectiveness of ruxolitinib, a JAK1/2 inhibitor, in combination with methylprednisolone in patients with newly diagnosed intermediate- or high-risk aGvHD. Patients were randomized 1:1 to receive ruxolitinib 5 mg/day plus methylprednisolone 1 mg/kg/day (n = 99) or methylprednisolone 2 mg/kg/day (n = 99). Results from this trial were published in Signal Transduction and Targeted Therapy by Dou et al.1 |
| Key learnings |
| The ORR was higher in the ruxolitinib plus corticosteroid combination group compared with corticosteroids alone on Day 28 (92.9% vs 70.7%; OR, 5.8; 95% CI, 2.4–14.0; p <0.001) and on Day 56 (85.9% vs 46.5%; OR, 7.07; 95% CI, 3.36–15.75; p < 0.001). |
| The ruxolitinib plus corticosteroid combination group showed improved 18-month failure-free survival vs corticosteroid alone (57.2% vs. 33.3%; HR, 0.46; 95% CI, 0.31–0.68; p < 0.001), suggesting a more durable response. |
| Grade ≥3 AEs were similar between the two groups; however, fewer Grade 4 AEs were observed in the combination group (26.3% vs 50.5%; p = 0.005). |
| Ruxolitinib treatment reduced corticosteroid exposure, potentially minimizing long-term immunosuppression without increasing infection rates. Abbreviations: CMV, cytomegalovirus; EFS, event-free survival; HCT, hematopoietic cell transplantation; HLA, human leukocyte antigen; NFT-BART, Nonparametric Failure Time Bayesian Additive Regression Trees; OS, overall survival. |
| The addition of ruxolitinib to methylprednisolone was well tolerated and improved response rates and failure-free survival while not increasing steroid exposure, NRM, mortality, or infectious complications. |
Abbreviations: AE, adverse event; aGvHD, acute graft-versus-host disease; CI, confidence interval; CIR, cumulative incidence of relapse; HR, hazard ratio; JAK, Janus kinase; NRM, non-relapsed mortality; OR, odds ratio; ORR, overall response rate; OS, overall survival.
- Dou L, Zhao Y, Yang J, et al. Ruxolitinib plus steroids for acute graft versus host disease: a multicenter, randomized, phase 3 trial. Signal Transduct Target Ther. 2024;9(1):288. DOI: 1038/s41392-024-01987-x
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