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Ruxolitinib in adult and pediatric steroid-refractory GvHD: Long-term real-world outcomes
The development of newer therapies, such as ruxolitinib, to target steroid-refractory or -dependent GvHD has led to improved disease response in clinical trials. However, real-world data to further assess long-term efficacy and safety are lacking. A retrospective, multi-center, observational study was conducted across 17 Spanish centers under the GETH-TC to evaluate the real-world experience of ruxolitinib in adult (n = 352) and pediatric patients (<14 years; n = 42) with steroid-refractory acute or chronic GvHD.1 Patients were assessed for their best response to ruxolitinib at any time after initiation. Results were published in Bone Marrow Transplantation by Escamilla-Gómez et al.1
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Key learnings |
| In adult patients, ruxolitinib demonstrated an ORR of 58.8% in aGvHD (CR, 33.6%) and 65.7% in cGvHD (CR, 18.5%). Response rates were higher in pediatric patients, with an ORR of 82.7% in aGvHD (CR, 51.7%) and 100% in cGvHD (CR, 23%). |
| Corticosteroids were withdrawn in 59.2% and 40.1% of adult responders with aGvHD and cGvHD, respectively, and ruxolitinib in 47.2% and 34.8%, respectively, suggesting a potential for long-term reduction in immunosuppression. |
| Cytopenias, most commonly thrombocytopenia and anemia, were the most frequent AEs, occurring in 19.3% of patients with aGvHD and 19.5% of patients with cGvHD overall. CMV reactivation occurred in 49.7% of adults with aGvHD and 30.5% with cGvHD, necessitating monitoring. |
| Findings from this study confirm that ruxolitinib can be used as a standard second-line therapy for steroid-refractory GvHD. In addition, earlier intervention in pediatric patients can lead to higher efficacy and reduction in corticosteroid use, facilitating long-term toxicity reduction. |
Abbreviations: AE, adverse event; aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease; CMV, cytomegalovirus; CR, complete remission; GETH-TC, Grupo Español de Trasplante Hematopoyético y Terapia Celular; GvHD, graft-versus-host disease; ORR, overall response rate.
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