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Ruxolitinib in steroid-refractory acute graft-vs-host disease: Japanese subgroup analysis of the randomized REACH2 trial.

Authors :
Teshima T
Onishi Y
Kato K
Taniguchi S
Miyamura K
Fukushima K
Kato J
Ishikawa T
Doki N
Nakamae H
Maeda Y
Inamoto Y
Okada M
Maki A
Shimada F
Tajima T
Wroclawska M
Zeiser R
Onizuka M
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).)

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