Enteric-coated mycophenolate sodium containing GvHD prophylaxis reduces GvHD rate after allogeneic HSCT

Eur J Haematol. 2016 Sep;97(3):232-8. doi: 10.1111/ejh.12710. Epub 2016 Jan 14.

Abstract

Objectives: The aim of this study was to evaluate whether cyclosporine A (CsA)-based Graft vs. Host Disease (GvHD) prophylaxis with enteric-coated mycophenolate sodium (EC-MPS) instead of mycophenolate mofetil (MMF) or methotrexate (MTX) reduces the GvHD incidence and lowers gastrointestinal (GI-) toxicities.

Methods: In a retrospective analysis of 102 allogeneic hematopoietic stem cell transplant (HSCT) patients, incidences of overall and severe aGvHD (>II°), cGvHD as well as overall and severe (CTC >II°) GI-toxicities were compared between GvHD prophylaxis containing EC-MPS vs. MMF or MTX (control group).

Results: The overall aGvHD rate was significantly lower in the EC-MPS group compared to the control (47% vs. 72%, P = 0.022) with lower rates of severe aGvHD (10% vs. 25%, P = 0.088) and cGvHD (20% vs. 39%, P = 0.065). Prophylaxis with EC-MPS remained significantly associated with a lower aGvHD rate in a multiple logistic regression model. GI-toxicities did not differ between both groups except for severe abdominal pain for which the incidence was increased in the EC-MPS group (17% vs. 3%, P = 0.022).

Conclusions: This data support the hypothesis that replacement of MMF or MTX by EC-MPS reduces GvHD rates after HSCT. This appears not to be due to a reduced GI-toxicity of EC-MPS.

Keywords: GvHD; allogeneic; enteric-coated; hematopoietic stem cell transplantation; methotrexate; mycophenolate; prophylaxis.

MeSH terms

  • Adult
  • Aged
  • Drug Compounding
  • Drug Interactions
  • Drug Therapy, Combination
  • Female
  • Graft vs Host Disease / diagnosis
  • Graft vs Host Disease / etiology*
  • Graft vs Host Disease / mortality
  • Graft vs Host Disease / prevention & control*
  • Hematopoietic Stem Cell Transplantation / adverse effects*
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / chemistry
  • Male
  • Methotrexate / therapeutic use
  • Middle Aged
  • Mycophenolic Acid / administration & dosage*
  • Mycophenolic Acid / adverse effects
  • Mycophenolic Acid / chemistry
  • Premedication*
  • Proton Pump Inhibitors / therapeutic use
  • Retrospective Studies
  • Tissue Donors
  • Transplantation Conditioning
  • Transplantation, Homologous
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Proton Pump Inhibitors
  • Mycophenolic Acid
  • Methotrexate