title: Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam® 10%) in patients with immune thrombocytopenia.
abstract: Intravenous immunoglobulin (IVIg) has an established role in the treatment of immune thrombocytopenia (ITP). The safety and efficacy of a new ready-to-use IVIg 10% formulation (octagam(®) 10%) were investigated in a prospective phase III study in 116 adult patients with ITP (platelet count ≤20×10(9)/l). Sixty-six patients had chronic ITP and 49 were newly diagnosed. Patients received octagam 10% 1 g/kg/day on two consecutive days; infusion rate was adjusted according to tolerability to a maximum of 0·12 ml/kg/minute. Eighty per cent of patients attained the primary efficacy endpoint of clinical response (platelet count ≥50×10(9)/l within 6 days of dosing). The median time to response was 2 days and the median duration of response was 12 days; mean response duration was 24·1 days. octagam 10% was well tolerated and effective in this population representative of adult patients with ITP, even at the maximum infusion rate of 0·12 ml/kg/minute, without unexpected safety issues.
authors.affiliation: Department of Hematology, Medical University of Lodz, Poland. robaktad@csk.umed.lodz.pl
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Robak
authors.forename: Claudia
authors.initials: C
authors.lastname: Mainau
authors.forename: Barbara
authors.initials: B
authors.lastname: Pyringer
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Chojnowski
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Warzocha
authors.forename: Anna
authors.initials: A
authors.lastname: Dmoszynska
authors.forename: Jan
authors.initials: J
authors.lastname: Straub
authors.forename: Paul
authors.initials: P
authors.lastname: Imbach
mesh_terms: D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D005260:Female; D006261:Headache / Q000139:chemically induced; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D011446:Prospective Studies; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D016756:Immunoglobulins, Intravenous; C495669:Octagam