Vigam-S, a solvent/detergent-treated intravenous immunoglobulin, in idiopathic thrombocytopenic purpura.
The efficacy of Vigam-S, a highly purified intravenous immunoglobulin, was investigated by an open, noncomparative study in 20 adults with chronic idiopathic thrombocytopenic purpura (ITP). Fifteen patients responded to the initial 3-day infusion of 0.4 g kg(-1) day(-1) by exhibiting an incremental increase in platelet count of >or= 30 x 10(9) L(-1), in eight of whom platelet count normalized (> 150 x 10(9) L(-1)). The peak platelet count for responders on day 4 was 163 x 10(9) L(-1) (baseline = 18 x 10(9) L(-1)). No benefit was derived from an extra 2 days infusion in nonresponders. Further treatment (either a single 0.8 g kg(-1) dose or another 3-day infusion) given to responders when platelet counts fell below 30 x 10(9) L(-1) was effective on eight of 14 occasions. Increases in total serum IgG concentration (to a mean peak of 25.3 g L(-1)) were not correlated with platelet response. There was no evidence of seroconversion to virus markers, or of alteration in renal function, following Vigam-S infusion. Most adverse events were mild and transient; however, three patients had severe headache and vomiting (possible aseptic meningitis syndrome) and one had marked superficial thrombophlebitis. Therefore Vigam-S provides effective and well tolerated therapy in the management of adults with ITP although individual patient response remains difficult to predict.
Newland
A C
AC
Department of Haematology, Royal London Hospital, Whitechapel, UK. A.C.Newland@mds.qmw.ac.uk
Burton
I
I
Cavenagh
J D
JD
Copplestone
A
A
Dolan
G
G
Houghton
J
J
Reilly
T
T
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D003902:Detergents; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000097:blood / Q000188:drug therapy*; D012016:Reference Values; D012997:Solvents; D013156:Splenectomy; D013997:Time Factors; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D003902:Detergents; D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous; D007166:Immunosuppressive Agents; D012997:Solvents