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

Abstract

Objectives: This Phase III study examined the efficacy and safety of Rhophylac^® (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 × 10⁹/l received a single intravenous injection of 50 μg/kg bodyweight Rhophylac^®.

Results: A response (defined as an increase in platelet count by ≥20 × 10⁹/l to ≥30 × 10⁹/l 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^® is well tolerated and efficacious in chronic ITP.

Keywords:

• AUTOIMMUNE THROMBOCYTOPENIC PURPURA
• HEMOLYSIS
• RHO(D) IMMUNE GLOBULIN
• RHOPHYLAC REG