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Ruxolitinib in steroid-refractory acute graft-vs-host disease: Japanese subgroup analysis of the randomized REACH2 trial.
- Source :
-
International journal of hematology [Int J Hematol] 2024 Jul; Vol. 120 (1), pp. 106-116. Date of Electronic Publication: 2024 May 25. - Publication Year :
- 2024
-
Abstract
- Acute graft-versus-host disease (aGvHD) is a major complication after allogeneic hematopoietic stem cell transplantation in Japan and other countries. Nearly one-third of patients do not respond to standard systemic steroid therapy and no standard second-line treatment has been established in Japan. We report efficacy and safety findings of ruxolitinib versus best available therapy (BAT) from a subgroup analysis of the international, phase 3 REACH2 study in Japanese patients with steroid-refractory aGvHD. The primary endpoint was overall response rate (ORR) at day 28. Overall, 9 patients received ruxolitinib and 21 received BAT. The ORR at day 28 (88.9% vs 52.4%) and durable ORR at day 56 (66.7% vs 28.6%) were higher with ruxolitinib versus BAT. The estimated cumulative incidence of loss of response at 6 months was 12.5% with ruxolitinib and 18.2% with BAT. The median failure-free survival was longer with ruxolitinib versus BAT (2.73 vs 1.25 months). The most common adverse events up to day 28 in the ruxolitinib and BAT groups were anemia (55.6% vs 19.0%) and thrombocytopenia (44.4% vs 4.8%, respectively). Ruxolitinib showed better efficacy outcomes and a consistent safety profile compared with BAT in the Japanese subgroup, and the findings were consistent with overall study results.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Middle Aged
Adult
Male
Female
Japan
Aged
Acute Disease
Steroids therapeutic use
Young Adult
Treatment Outcome
Adolescent
East Asian People
Nitriles
Pyrazoles therapeutic use
Pyrazoles adverse effects
Pyrimidines therapeutic use
Graft vs Host Disease drug therapy
Graft vs Host Disease etiology
Hematopoietic Stem Cell Transplantation
Subjects
Details
- Language :
- English
- ISSN :
- 1865-3774
- Volume :
- 120
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- International journal of hematology
- Publication Type :
- Academic Journal
- Accession number :
- 38796666
- Full Text :
- https://doi.org/10.1007/s12185-024-03772-6