Efficacy and safety of intravenous anti-D immunoglobulin (Rhophylac®) in chronic immune thrombocytopenic purpura

Objectives: This Phase III study examined the efficacy and safety of Rhophylac((R)) ( CSL Behring AG, Bern, Switzerland), a highly pure, liquid- stable anti- D preparation, in chronic immune thrombocytopenic purpura ( ITP). Materials and methods: Ninety- eight patients ( 96 adults, two adolescents) with chronic ITP and platelet counts,30 x 10(9)/1 received a single intravenous injection of 50 mu g/ kg bodyweight Rhophylac((R)). Results: A response ( defined as an increase in platelet count by >= 20 x 10(9)/1 to >= 30 x 10(9)/1 in the first 15 days after treatment) was seen in 66% of patients. Mean time to response was 3.1 +/- 3.0 days, and mean duration of response was 19.2 +/- 1.1 days for responders. The most frequent drug- related adverse events were chills, pyrexia, an increase in bilirubin, and headache; events were mainly mild or moderate. There was no severe hemolysis or renal failure. Conclusion: Rhophylac((R)) is well tolerated and efficacious in chronic ITP.