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Ruxolitinib plus corticosteroids in newly diagnosed patients with aGvHD: Results from a phase III trial

By Dylan Barrett

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Nov 18, 2024

Learning objective: After reading this article, learners will be able to cite a new clinical development in acute graft-versus-host disease.



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.

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