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

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

Object Details

• Location: Deutsche Nationalbibliothek Frankfurt am Main
• Extent: Online-Ressource
• Language: Englisch
• Notes: International journal of hematology. - 120, 1 (2024) , 106-116, ISSN: 1865-3774

Contributors, Places and Time

• Event: Veröffentlichung
• (where): Freiburg
• (who): Universität
• (when): 2024
• Creator: Teshima, Takanori ; Onishi, Yasushi ; Kato, Koji ; Taniguchi, Shuichi ; Miyamura, Koichi ; Fukushima, Kentaro ; Kato, Jun ; Ishikawa, Takayuki ; Doki, Noriko ; Nakamae, Hirohisa ; Maeda, Yoshinobu ; Inamoto, Yoshihiro ; Okada, Masaya ; Maki, Akio ; Shimada, Fumika ; Tajima, Takeshi ; Wroclawska, Monika ; Zeiser, Robert ; Onizuka, Makoto

Further information

• DOI: 10.1007/s12185-024-03772-6
• URN: urn:nbn:de:bsz:25-freidok-2492693
• Rights: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Last update: 15.08.2025, 7:21 AM CEST