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Stem cell transplantation

Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a multicenter survey

Leukemia volume 29, pages 2062–2068 (2015)Cite this article

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Abstract

Despite major improvements in allogeneic hematopoietic cell transplantation over the past decades, corticosteroid-refractory (SR) acute (a) and chronic (c) graft-versus-host disease (GVHD) cause high mortality. Preclinical evidence indicates the potent anti-inflammatory properties of the JAK1/2 inhibitor ruxolitinib. In this retrospective survey, 19 stem cell transplant centers in Europe and the United States reported outcome data from 95 patients who had received ruxolitinib as salvage therapy for SR-GVHD. Patients were classified as having SR-aGVHD (n=54, all grades III or IV) or SR-cGVHD (n=41, all moderate or severe). The median number of previous GVHD-therapies was 3 for both SR-aGVHD (1–7) and SR-cGVHD (1–10). The overall response rate was 81.5% (44/54) in SR-aGVHD including 25 complete responses (46.3%), while for SR-cGVHD the ORR was 85.4% (35/41). Of those patients responding to ruxolitinib, the rate of GVHD-relapse was 6.8% (3/44) and 5.7% (2/35) for SR-aGVHD and SR-cGVHD, respectively. The 6-month-survival was 79% (67.3–90.7%, 95% confidence interval (CI)) and 97.4% (92.3–100%, 95% CI) for SR-aGVHD and SR-cGVHD, respectively. Cytopenia and cytomegalovirus-reactivation were observed during ruxolitinib treatment in both SR-aGVHD (30/54, 55.6% and 18/54, 33.3%) and SR-cGVHD (7/41, 17.1% and 6/41, 14.6%) patients. Ruxolitinib may constitute a promising new treatment option for SR-aGVHD and SR-cGVHD that should be validated in a prospective trial.

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Acknowledgements

DFG (RZ, ZE872/3-1), NIH (BRB, P01 CA142106), German José Carreras Leukemia Foundation (AN, AH06-01), DKTK (RZ, NVB).

Author contributions

Authors contributed patient data and reviewed the manuscript. ASG analyzed the histopathology of the intestinal GVHD patient that was treated with ruxolitinib and provided the images. JD, RF and BRB contributed the data on murine cGVHD. GI helped the statistical analysis of the study. RZ and NVB analyzed the data and wrote the manuscript.

Author information

Authors and Affiliations

  1. Department of Hematology, Oncology and Stem Cell Transplantation, Freiburg University Medical Center, Freiburg, Germany

    R Zeiser, K Maas-Bauer, P Apostolova, H Bertz, R Marks, M Lübbert, R Wäsch, J Finke, J Duyster & N von Bubnoff

  2. Department of Hematology, Oncology and Immunology, Philipps University Marburg, and University Medical Center Giessen and Marburg, Marburg, Germany

    A Burchert, S K Metzelder & A Neubauer

  3. Division of Hematology, University Hospital of Basel, Basel, Switzerland

    C Lengerke, M Ecsedi, J Passweg & J Halter

  4. III Department of Internal Medicine, Technical University of Munich, Munich, Germany

    M Verbeek, S Spoerl & C Peschel

  5. Department of Bone Marrow Transplantation, West German Cancer Center, University Hospital Essen, Essen, Germany

    M Ditschkowski & D Beelen

  6. Department of Hematology and Oncology, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany

    K Sockel, F Stölzel & R Ordemann

  7. Department of Stem Cell Transplantation, University Hospital Hamburg-Eppendorf, Hamburg, Germany

    F Ayuk & N Kröger

  8. Department of Internal Medicine II, University Hospital, Frankfurt/Main, Germany

    S Ajib & G Bug

  9. Hematology Stem cell transplant Unit, Saint Louis Hospital, APHP, Paris, France

    F S de Fontbrune & G Socié

  10. Department of Stem Cell Transplantation, Charité University Medicine Berlin, Berlin, Germany

    I-K Na, L Penter & R Arnold

  11. Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany

    U Holtick & C Scheid

  12. Medical Clinic III, Oncology, Hematology and Rheumatology, University Hospital Bonn (UKB), Bonn, Germany

    D Wolf

  13. Department of Hematology, Oncology and Clinical Immunology, Universitätsklinikum Düsseldorf, Düsseldorf, Germany

    E Schuler & G Kobbe

  14. Department of Bone Marrow Transplantation, Stanford University Medical School, Stanford, CA, USA

    E Meyer & R Negrin

  15. Department of Internal Medicine, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden

    M Brune

  16. Department of Bone Marrow Transplantation, Patras University Medical School, Patras, Greece

    A Spyridonidis

  17. Department of Pathology, Freiburg University Medical Center, Freiburg, Germany

    A Schmitt-Gräff

  18. Radboud University Medical Centre, Nijmegen, The Netherlands

    W van der Velden & G Huls

  19. Department of Hematology and Oncology, University Medical Centre Würzburg, Würzburg, Germany

    S Mielke & G U Grigoleit

  20. Department of Hematology, University Medical Center Utrecht, Utrecht, The Netherlands

    J Kuball

  21. Department of Pediatrics, Division of Blood and Marrow Transplantation, University of Minnesota, Minneapolis, MN, USA

    R Flynn, J Du & B R Blazar

  22. Department of Hematology, Clinical Trials Unit, Freiburg University Medical Center, Freiburg, Germany

    G Ihorst

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  1. R Zeiser
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Correspondence to R Zeiser.

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Competing interests

FA, UH, CS, GB, JK, NK, NVB: Research support from Novartis, Bristol Meyer Squibb. DW: grants and personal fees from Novartis. RZ: Speakers fee from Bristol Meyer Squibb, travel grant from Gilead. All grants from Novartis were outside/unrelated to the submitted work. The other authors declare no conflict of interest.

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Zeiser, R., Burchert, A., Lengerke, C. et al. Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a multicenter survey. Leukemia 29, 2062–2068 (2015). https://doi.org/10.1038/leu.2015.212

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