High dose bolus methylprednisolone for the treatment of acute graft versus host disease.

Nineteen patients with acute graft versus host disease (GvHD) following bone marrow transplantation (BMT) were treated with high dose bolus 6-methylprednisolone (BMPr), at the dose of 20 mg/kg/day i.v. for the first 3 days, 10 mg/kg/day i.v. for the following 4 days, and then at doses gradually tapered down to 1 mg/kg/day. All patients except one, who was given preventive BMPr 5 mg/kg/day i.v. on alternate days, were placed on preventive methotrexate therapy after BMT. Sixteen patients were grafted with an HLA matched, and three patients with an HLA mismatched marrow. Overall complete response rate in the HLA matched group was 43%, with an additional 50% showing a partial response. In the HLA mismatched group there were no responses and all three patients proved refractory to BMPr. With respect to organ involvement the complete and partial response rates were respectively 50% and 33% in the skin, 36% and 28% in the liver, 18% and 55% in the gut. Six of sixteen patients in the HLA matched group and none of the three in the HLA mismatched group are surviving. Thirteen patients died: nine patients for causes directly or indirectly related to GvHD, four of other causes (relapse, rejection, hemorrhage and idiopathic interstitial pneumonia). Side effects of BMPr consisted in hyperglicemia, and steroid associated gastritis in 2/3 of the patients, both of which responded well to conventional treatment. This study indicates that high dose BMPr is an effective form of treatment for established acute GvHD, and has no major side effects. The efficacy of BMPr is less clear in recipients of HLA mismatched grafts.

RCT Entities:   Population Interventions Outcomes