title: A multi-centre study of efficacy and safety of Intratect®, a novel intravenous immunoglobulin preparation.
abstract: We studied the efficacy, safety and pharmacokinetic profiles of Intratect®, a recently developed polyvalent intravenous immunoglobulin (IVIG) preparation. Fifty-one patients (aged 6-48 years) with primary immunodeficiencies (PID) and established replacement therapy using a licensed IVIG were enrolled and treated for 12 months with Intratect®. Retrospective patient data served as prestudy controls. The primary efficacy variable was the annual rate of acute serious bacterial infection (ASBI) per patient. Secondary parameters were annual rate of acute relevant infection (ARI), days with antibiotic use, fever, absence from school/work and hospitalization. The average IVIG dose was 0·49 g/kg, with an average infusion rate of 2·4 ml/kg/h. The annual ASBI rate/patient was 0·02 and ARIs were detected 128 times during the 630 adverse events in 40 patients, specified mainly as bronchitis, sinusitis, respiratory tract infection, rhinitis and pharyngitis. The annual rate of respiratory ARIs/patient was 2·0 and the rates/patient for days with fever >38°C, school/work absence and hospitalization were 1·81, 3·99 and 0·36, respectively. A total of 630 adverse events (AEs) were observed in 50 of 51 (98·0%) of patients. In 46 of 51 patients the AEs were not related to infusion. Pharmacokinetic studies after the first infusion revealed a mean elimination half-life of 50·8 ± 30·3 days. During this study, 19 of 649 (2·9%) IgG trough levels were below 6 g/l, better than that of reference IVIGs during the 6 months before study start (10 of 201). These data suggest that Intratect® is a well tolerated, safe and effective IgG concentrate for the treatment of patients with PID.
authors.affiliation: Department of Pediatrics, Johann Wolfgang Goethe University, Frankfurt, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Kreuz
authors.forename: M
authors.initials: M
authors.lastname: Erdös
authors.forename: P
authors.initials: P
authors.lastname: Rossi
authors.forename: E
authors.initials: E
authors.lastname: Bernatowska
authors.forename: T
authors.initials: T
authors.lastname: Espanol
authors.forename: L
authors.initials: L
authors.lastname: Maródi
mesh_terms: D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001991:Bronchitis / Q000139:chemically induced; D002648:Child; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D007155:Immunologic Factors / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D007239:Infections / Q000139:chemically induced; D007262:Infusions, Intravenous; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D011446:Prospective Studies; D012852:Sinusitis / Q000139:chemically induced; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors