Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation
Summary
Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation.
Timeline
- Start
- 2017-03-10
- Primary completion
- 2019-06-24
- Completion
- 2021-04-23
Outcome
Met primary endpoint
paper Overall response at day 28 was higher in the ruxolitinib group than in the control group PMID 32320566 ↗
registry analysis (superiority test); Ruxolitinib (RUX) vs Best Available Therapy (BAT); p <.0001; Odds Ratio (OR) 2.64 (95% CI 1.65 to 4.22) NCT02913261 ↗
release “Results of randomized Phase 3 REACH2 trial show that ruxolitinib significantly improves overall response rate (ORR) at 28 days vs. best available therapy” incyte.com ↗
release “REACH2, the first Phase 3 study of ruxolitinib in acute GVHD to have met its primary endpoint” incyte.com ↗
release “Results from the REACH2 trial showed that overall response rate (ORR) at Day 28 was superior in the Jakavi arm at 62.3% vs. 39.4%” novartis.com ↗
Publications
- Mahmoudjafari Z, Bhatt V, Xue Z, Locatelli F, Socie G, Zeiser R. Clinical considerations for ruxolitinib in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) and steroid-refractory or -dependent chronic GVHD: a plain language summary. Ther Adv Hematol. 2026 May 19;17:20406207261442908. doi: 10.1177/20406207261442908. eCollection 2026.
- Mohty M, Socie G, Szer J, Niederwieser D, Butler J, Wagner-Drouet E, Or R, Rovenvald-Zuckerman T, Bozdag SC, Forcade E, Grillo G, Kroger N, Stolzel F, Russo D, Sanz J, Sarkar R, Stefanelli T, Wilke C, Zeiser R, von Bubnoff N. Ruxolitinib Versus Best Available Therapy in Patients With Steroid-Refractory Acute Graft-Versus-Host Disease: Final Analysis From the Randomized Phase III REACH2 Trial. J Clin Oncol. 2025 Dec;43(34):3639-3645. doi: 10.1200/JCO-25-00809. Epub 2025 Oct 15.
- Mahmoudjafari Z, Kintsch E, Xue Z, Bhatt V, Galvin J, Locatelli F, Zeiser R. Impact of concomitant azoles on ruxolitinib treatment in patients with GVHD: post hoc analyses of REACH2 and REACH3. Blood Adv. 2025 Aug 26;9(16):4206-4216. doi: 10.1182/bloodadvances.2025016212.
- Socie G, Niederwieser D, von Bubnoff N, Mohty M, Szer J, Or R, Garrett J, Prahallad A, Wilke C, Zeiser R. Prognostic value of blood biomarkers in steroid-refractory or steroid-dependent acute graft-versus-host disease: a REACH2 analysis. Blood. 2023 Jun 1;141(22):2771-2779. doi: 10.1182/blood.2022018579.
- Zeiser R, von Bubnoff N, Butler J, Mohty M, Niederwieser D, Or R, Szer J, Wagner EM, Zuckerman T, Mahuzier B, Xu J, Wilke C, Gandhi KK, Socie G; REACH2 Trial Group. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med. 2020 May 7;382(19):1800-1810. doi: 10.1056/NEJMoa1917635. Epub 2020 Apr 22.
- Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etanercept | Protein / enzyme biologic | — | — |
| Comparator | Everolimus | Small molecule | — | — |
| Comparator | Infliximab | Monoclonal antibody | — | — |
| Comparator | Mesenchymal Stromal Cells | Cell therapy | — | — |
| Comparator | Methotrexate | Small molecule | — | — |
| Comparator | Mycophenolate Mofetil | Small molecule | — | — |
| Subject | Ruxolitinib | Small molecule | 10 mg | Oral |
| Comparator | Sirolimus | Small molecule | — | — |