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

Standort
Deutsche Nationalbibliothek Frankfurt am Main
Umfang
Online-Ressource
Sprache
Englisch
Anmerkungen
International journal of hematology. - 120, 1 (2024) , 106-116, ISSN: 1865-3774

Ereignis
Veröffentlichung
(wo)
Freiburg
(wer)
Universität
(wann)
2024
Urheber
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

DOI
10.1007/s12185-024-03772-6
URN
urn:nbn:de:bsz:25-freidok-2492693
Rechteinformation
Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
Letzte Aktualisierung
15.08.2025, 07:21 MESZ

Datenpartner

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Beteiligte

  • 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
  • Universität

Entstanden

  • 2024

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