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Treatment with 3 cycles of pulsed high-dose dexamethasone (HD-DXM) appears to be an effective regimen for patients with idiopathic thrombocytopenic purpura (ITP) who are treatment-naïve, according to a study presented at the 2017 American Society of Hematology Annual Meeting (ASH 2017). Investigators compared the use of pulsed HD-DXM with conventional prednisone therapy and found there were fewer adverse effects with pulsed HD-DXM.
Corticosteroid therapy is the standard first-line therapy for patients with ITP. However, recent studies have demonstrated that pulsed HD-DXM given at a dose 40 mg/day on a 4-day treatment course treatment may be superior to corticosteroid therapy. In the current study, Saeid Rezaei Jouzdani, MD, of the department of Internal Medicine at Isfahan University of Medical Sciences, Isfahan, Iran, and colleagues conducted a randomized controlled clinical trial to compare efficacy and relapse-free survival time of 3 therapy cycles of HD-DXM with that of conventional treatment with prednisone for untreated adult patients with ITP.
The single center study included patients aged 18 years or older with newly diagnosed primary ITP according to the international working group (IWG) guideline. Patients were randomly assigned to either HD-DXM or prednisone. The HD-DXM arm received HD-DXM 40 mg in 500 cc normal saline (0.9% saline) IV over 1 hour for 4 consecutive days, then stopped. The cycle was repeated in 14-day intervals for a total of 3 treatment cycles. Patients in the prednisone arm received treatment orally at 1.0 mg/kg daily for 4 consecutive weeks. In this study, once patients achieved good responses treatment was gradually tapered to less than 15 mg daily or terminated over 4 to 6 weeks with the goal of maintaining platelet count over 30×109/L.
The investigators obtained a weekly blood count for the first 4 weeks and then each month up to 1 year or until loss of response. The team compared baseline parameters such as platelet count between the 2 arms by Fisher exact test. The correlation between response and baseline parameters were evaluated with a logistic regression model.
A total of 36 patients were enrolled in each arm and researchers found at the end of the third cycle the overall response rate (ORR) was higher in the HD-DXM arm compared with the prednisone arm. They also found that the relapse rate of the HD-DXM arm was lower than the prednisone arm at 12 months after discontinuation of therapy. Fewer adverse events were found in the HD-DXM arm. If validated in larger, multicenter studies, these findings may point the way toward a new standard of care in this patient population.
Jouzdani SR. Therapy of adults affected by idiopathic thrombocytopenic purpura with 3 cycles pulses of high-dose dexamethasone (HD-DXM): a prospective randomized clinical trial. Poster presentation at: 2017 American Society of Hematology Annual Meeting; December 9-12, 2017; Atlanta, GA. Abstract 3648.