According to a new study published in the journal The Lancet Oncology, researchers have found that the addition of tocilizumab to standard graft-versus-host disease (GVHD) prophylaxis following allogenic stem-cell transplantation may be effective to protect against acute GVHD.
Interleukin 6 is the key unregulated cytokine released after allogenic stem-cell transplantation, so the researchers sought to investigate whether tocilizumab, a humanized anti-interleukin 6 receptor monoclonal antibody, could inhibit interleukin 6, thereby preventing GVHD.
For the phase 1/2 study, researchers enrolled 48 patients aged 18 to 65 years who underwent T-replete HLA-matched allogenic stem-cell transplantation with either total body irradiation-based myeloblative or reduced-intensity conditioning from unrelated or sibling stem-cell donors.
Patients received cyclosporine and methotrexate, the standard GVHD prophylaxis, plus tocilizumab 8mg/kg (maximum dose 800mg) intravenously over 60 minutes the day before allogenic stem-cell transplantation. At day 100, 12% (95% CI: 5-24) of patients experienced grade 2-4 acute GVHD and 4% (95% CI: 1-13) experienced grade 3-4 acute GVHD.
Of the 48 patients, 10% developed grade 2-4 acute GVHD involving the skin and 8% developed acute GVHD involving the gastrointestinal tract. The researchers suggest a randomized, controlled study be conducted to assess the addition of tocilizumab to cyclosporine and methotrexate to reduce the risk for developing GVHD.
The authors aimed to assess whether the humanised anti–interleukin–6 receptor monoclonal antibody, tocilizumab, could attenuate the incidence of acute GVHD.
Interleukin 6 is the main detectable and dysregulated cytokine secreted after allogeneic SCT and its inhibition is a potential new and simple strategy to protect from acute GVHD despite robust immune reconstitution; a randomised, controlled trial assessing tocilizumab in addition to standard GVHD prophylaxis in these patients is warranted.