title: Intravenous immunoglobulin or high-dose methylprednisolone, with or without oral prednisone, for adults with untreated severe autoimmune thrombocytopenic purpura: a randomised, multicentre trial.
abstract: BACKGROUND
  Treatment of adults with autoimmune thrombocytopenic purpura (AITP) is based more on individual experience than on results of controlled studies. We compared intravenous immunoglobulin with high-dose methylprednisolone in untreated adults with severe AITP and assessed efficacy of subsequent oral steroids compared with placebo. Primary outcome was number of days with platelet count greater than 50 x 10(9)/L within the first 21 days.
  
  
  METHODS
  We did a randomised multicentre trial based on a 232 design. 122 adults with severe AITP (platelet count < or =20 x 10(9)/L) were randomly assigned to receive either intravenous immunoglobulin or high-dose methylprednisolone on days 1-3 (randomisation A), and then to receive either oral prednisone or placebo (randomisation B) on days 4-21. Analysis was by intention to treat.
  
  
  RESULTS
  Six patients were excluded from the analysis. The number of days on which platelet counts were above 50 x 10(9)/L was 18 in 56 patients receiving intravenous immunoglobulin and 14 in 60 receiving high-dose methylprednisolone (p=0.02). Percentage of patients who had platelet counts over 50 x 10(9)/L on days 2 and 5 was 7% and 79%, respectively, in the intravenous immunoglobulin group compared with 2% and 60%, respectively, in the high-dose methylprednisolone group (p=0.04). During the second treatment period, prednisone was more effective than placebo for all short-term endpoints. Patients who received intravenous immunoglobulin and prednisone had platelet count greater than 50 x 10(9)/L for 18.5 days (p=0.005), and those treated with high-dose methylprednisolone and prednisone had this count for 17.5 days.
  
  
  CONCLUSIONS
  Intravenous immunoglobulin and oral prednisone seems to be more effective than high-dose methylprednisolone and oral prednisone in adults with severe AITP, although the latter treatment is effective and well tolerated.
authors.affiliation: Laboratoire d'Immunologie Leucoplaquettaire, EFS Ile de France, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Godeau
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Bruno
authors.initials: B
authors.lastname: Varet
authors.forename: François
authors.initials: F
authors.lastname: Lefrère
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Zini
authors.forename: François
authors.initials: F
authors.lastname: Bassompierre
authors.forename: Stéphane
authors.initials: S
authors.lastname: Chèze
authors.forename: Eric
authors.initials: E
authors.lastname: Legouffe
authors.forename: Cyrille
authors.initials: C
authors.lastname: Hulin
authors.forename: Marie José
authors.initials: MJ
authors.lastname: Grange
authors.forename: Olivier
authors.initials: O
authors.lastname: Fain
authors.forename: Philippe
authors.initials: P
authors.lastname: Bierling
mesh_terms: D000328:Adult; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use*; D008875:Middle Aged; D010976:Platelet Count; D011241:Prednisone / Q000627:therapeutic use*; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D016756:Immunoglobulins, Intravenous; D011241:Prednisone; D008775:Methylprednisolone