Immunomodulatory effect of vitamin D after allo-SCT

Purpose: we describe the results of a prospective multicenter phase I/II trial evaluating the impact of the use of vitamin D (VitD) from day -5 to +100 on the outcome of patients undergoing allogeneic transplantation (EudraCT: 2010-023279-25; ClinicalTrials.gov: NCT02600988). Patients and methods:150 patients were included in three consecutive cohorts of 50 patients each group: control group (CG, not receive VitD); low dose group (LdD, received 1,000 UI VitD daily; and high dose group (HdD, 5,000 UI VitD daily). We measured levels of VitD, cytokines and immune subpopulations after transplantation. Results: No significant differences were observed in terms of cumulative incidence of overall and grades II-IV acute graft-versus-host disease (aGVHD), in terms of relapse, non-relapse mortality and overall survival. However a significantly lower cumulative incidence of both overall and moderate plus severe chronic GVHD at 1 year was observed in LdD (37.5% and 19.5%, respectively) and HdD (42.4% and 27%, respectively) as compared to CG (67.5% and 44.7%, respectively) (p<0.05). In multivariable analysis, treatment with VitD significantly decreased the risk of both overall: for LdD (HR=0.31, p=0.002) and for HdD (HR=0.36, p=0.006) and moderate plus severe cGVHD: for LdD (HR=0.22, p=0.001) and for HdD (HR=0.33, p=0.01). VitD modified the immune response, decreasing number of B-cells, naïve CD8 T-cells and with a lower expression of CD40L. Conclusions: This is the first prospective trial which analyzes the effect of VitD postransplant. We observed a significantly lower incidence of cGVHD among patients receiving VitD. Interestingly, VitD modified the immune response after alloSCT.

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