title: Efficacy and safety of intravenous anti-D immunoglobulin (Rhophylac) in chronic immune thrombocytopenic purpura.
abstract: 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.
authors.affiliation: University Clinics Charite, Berlin, Germany. louis.aledort@mssm.edu
authors.forename: L M
authors.initials: LM
authors.lastname: Aledort
authors.forename: A
authors.initials: A
authors.lastname: Salama
authors.forename: L
authors.initials: L
authors.lastname: Kovaleva
authors.forename: T
authors.initials: T
authors.lastname: Robak
authors.forename: A C
authors.initials: AC
authors.lastname: Newland
authors.forename: D J
authors.initials: DJ
authors.lastname: Nugent
authors.forename: B
authors.initials: B
authors.lastname: Brenner
authors.forename: O
authors.initials: O
authors.lastname: Zenker
mesh_terms: 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
chemical_list: D018029:Rho(D) Immune Globulin