Tocilizumab High Active For Refractory Graft vs Host Disease Interview with:

Dr. Alex Ganetsky

Dr. Alex Ganetsky

Alex Ganetsky, PharmD, BCOP
Clinical Pharmacy Specialist – Hematology/BMT
Hospital of the University of Pennsylvania What is the background for this study? What are the main findings?

• Allogeneic hematopoietic cell transplant (HCT) recipients with steroid-refractory gastrointestinal acute graft-versus-host disease (GI-GVHD) have poor outcomes.
• There is no consensus for optimal treatment of these patients.
• We retrospectively evaluated the efficacy of tocilizumab, an interleukin-6 receptor monoclonal antibody, for the treatment of steroid-refractory GI-GVHD.
• 10/11 (91%) patients achieved a complete response after a median time of 11 days (range, 2 – 18) from tocilizumab initiation.
• The median time to response onset, defined as improvement in GVHD stage by at least 1, was 1 day (range, 1 – 6).
• At a median follow-up of 3 months (range, 1.1 – 12.8) from tocilizumab initiation, 8 of 11 patients are alive and free of the their underlying hematologic malignancy.
• No associations between serum levels of IL-6 and tocilizumab response could be identified. What should readers take away from your report?

• Tocilizumab appears to be highly active for the treatment of steroid-refractory GI-GVHD.
• Of note, this a retrospective analysis involving a small number of patients and thus detailed evaluation through prospective clinical trials is warranted. What recommendations do you have for future research as a result of this study?

• Our findings provide the rationale for studying tocilizumab in the treatment of steroid-refractory GI-GVHD in a prospective trial to better understand tocilizumab’s efficacy and safety profile in the HCT setting.
• It is also critical to further characterize the precise mechanism associated with tocilizumab’s activity in GVHD particularly involving the GI tract. Thank you for your contribution to the community.

upcoming ASH abstract:
Tocilizumab Is Highly Active for Severe Steroid-Refractory Acute Graft-Versus-Host Disease of the Gastrointestinal Tract

Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution
Program: Oral and Poster Abstracts
Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I
Saturday, December 3, 2016, 5:30 PM-7:30 PM
Hall GH (San Diego Convention Center)
Alex Ganetsky, PharmD, BCOP1,2*, Noelle V Frey, MD2, Alison W Loren, MD, MS3, Elizabeth O. Hexner, MD4, James K Mangan, MD, PhD2, Saar I Gill, MBBS, PhD2,5, Selina Luger, MD2, Adam D. Cohen, MD6, Daria V. Babushok, MD, PhD7, Edward A Stadtmauer, MD7, Jacqueline Smith, CRNP7*, William R. Drobyski, MD8, Sarah K Kraus, PharmD1*, Colleen Timlin, PharmD, BCOP1,7* and David L. Porter, MD7

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Last Updated on December 5, 2016 by Marie Benz MD FAAD