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


METHODS
Ninety-eight patients (96 adults, two adolescents) with chronic ITP and platelet counts < 30 x 10(9)/l received a single intravenous injection of 50 microg/kg bodyweight Rhophylac.


RESULTS
A response (defined as an increase in platelet count by >or= 20 x 10(9)/l to >or= 30 x 10(9)/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.


CONCLUSIONS
rhophylac is well tolerated and efficacious in chronic itp.
Aledort
L M
LM
University Clinics Charite, Berlin, Germany. louis.aledort@mssm.edu
Salama
A
A
Kovaleva
L
L
Robak
T
T
Newland
A C
AC
Nugent
D J
DJ
Brenner
B
B
Zenker
O
O
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D023341:Chills / Q000139:chemically induced; D002908:Chronic Disease; D005260:Female; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D007167:Immunotherapy; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000150:complications / Q000628:therapy*; D018029:Rho(D) Immune Globulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D018029:Rho(D) Immune Globulin