Ruxolitinib for steroid-refractory chronic graft-versus-host disease: Japanese subgroup analysis of REACH3 study
Ruxolitinib, a Janus kinase (JAK1-JAK2) inhibitor, has demonstrated safety and efficacy in patients with graft-versus-host disease (GvHD). This phase 3 randomized trial (REACH3) evaluated the efficacy and the safety of ruxolitinib 10 mg twice daily compared with investigator-selected best available therapy (BAT) in a subgroup of Japanese patients (n = 37) with steroid-refractory or dependent (SR/D) chronic GvHD. At data cut-off, treatment was ongoing in 17 patients and discontinued in 20. The overall response rate (complete or partial) at week 24 was greater with ruxolitinib than BAT (50% vs. 20%; odds ratio, 4.13 [95% CI, 0.90-18.9]). The best overall response rate (complete or partial response at any time point up to week 24) was higher with ruxolitinib than BAT (68.2% vs. 46.7%; odds ratio, 2.69 [95% CI, 0.66-10.9]). Ruxolitinib led to longer median failure-free survival than BAT (18.6 months vs. 3.7 months; hazard ratio, 0.34; [95% CI, 0.14-0.85]). The most common grade ≥ 3 adverse events up to week 24 were anemia (ruxolitinib: 22.7%; BAT: 6.7%) and pneumonia (22.7% and 20.0%, respectively). Ruxolitinib showed a higher response rate and improvement in failure-free survival in Japanese patients with SR/D chronic GvHD, with a safety profile consistent with the overall study population.
Authors
- Naoyuki Uchida (ORCID: https://orcid.org/0000-0001-5952-5926)
- Masako Toyosaki (ORCID: https://orcid.org/0009-0008-6455-3831)
- Tatsunori Goto (ORCID: https://orcid.org/0000-0002-0314-9498)
- Yoshinobu Maeda (ORCID: https://orcid.org/0000-0003-1634-5487)
- Koji Kato (ORCID: https://orcid.org/0000-0002-5815-4585)
- Fumika Shimada
- Noriko Doki (ORCID: https://orcid.org/0000-0002-8661-3179)
- Tadakazu Kondo (ORCID: https://orcid.org/0000-0002-8959-6271)
- Takanori Teshima (ORCID: https://orcid.org/0000-0002-0941-271X)
- Souichi Shiratori (ORCID: https://orcid.org/0000-0002-5528-7112)
- Masaya Okada (ORCID: https://orcid.org/0000-0002-4037-6040)
- Kentaro Fukushima (ORCID: https://orcid.org/0000-0002-8003-2584)
- Takashi Ikeda (ORCID: https://orcid.org/0000-0003-3976-5230)
- Yasushi Onishi (ORCID: https://orcid.org/0000-0003-0032-6994)
- Hirohisa Nakamae (ORCID: https://orcid.org/0000-0003-4203-990X)
- Takeshi Tajima
- Takayuki Ishikawa (ORCID: https://orcid.org/0000-0002-4356-4039)
- Tommaso Stefanelli
- Akio Maki
Institutions
- Hokkaido University of Science (JP)
- Kansai Medical University (JP)
- Novartis (Switzerland) (CH)
- Tokai University (JP)
- Hyogo Medical University (JP)
- Okayama University (JP)
- Hokkaido University (JP)
- Kyoto University (JP)
- Tokyo Metropolitan Komagome Hospital (JP)
- Shizuoka Cancer Center (JP)
- Tohoku University Hospital (JP)
- Kyushu University Hospital (JP)
- Novartis (Japan) (JP)
- Japanese Red Cross Nagoya Daiichi Hospital (JP)
- Kobe City Medical Center General Hospital (JP)
- Toranomon Hospital (JP)
- Tokyo Metropolitan University (JP)
- Hyogo University (JP)
- The University of Osaka (JP)
Publication Details
- Journal
- International Journal of Hematology
- Published
- 2024-10-03
- DOI
- https://doi.org/10.1007/s12185-024-03850-9
- Citations
- 1
- Primary Topic
- Hematopoietic Stem Cell Transplantation
- Type
- article
- Field-Weighted Citation Impact
- 0.45
Funders
- Novartis
- Keio University
- Jichi Medical University
- Hyogo College of Medicine
- Hokkaido University
- Novartis Pharma