title: Safety monitoring of the intravenous immunoglobulin preparation Intratect® in primary and secondary immunodeficiencies: a prospective non-interventional study.
abstract: OBJECTIVE
  To better characterize the risk profile of the intravenous immunoglobulin (IVIG) Intratect®, a non-interventional study was undertaken to systematically collect large-scale safety information under real-life conditions in patients with primary and secondary immunodeficiency. Secondary objectives were data on treatment modalities.
  
  
  METHODS
  A prospective, non-interventional study was performed at 95 centers. RESULTS of an interim analysis are reported here. Intratect® (50 g/L) was administered at the physician's discretion. Data were captured from patients with different causes of immunodeficiency (61.5% with malignancy) at routine clinic visits, with a particular focus on the frequency and causality of adverse events.
  
  
  RESULTS
  1,313 patients were followed for a median of 294 days. At study entry, 836 patients (63.7%) were receiving therapy, most frequently IVIG treatment (37.2%). In total, 21,995 Intratect® infusions were documented (median 11 infusions per patient, median dose 200 mL). Median serum IgG level increased from 5.78 (interquartile range 3.70, 8.87) g/L at month 1 to 6.58 (4.82, 9.48) g/mL at month 12. Altogether, 689 adverse events were collected, irrespective of causality. From these, 225 (32.7%) were assessed as related to Intratect® and thus considered suspected adverse drug reactions (ADRs). Thus, the ADR rate was 1.0% per infusion. Seven ADRs (7/225, 3.1%) were graded serious. In all cases, the patients had recovered or were recovering at the time of reporting.
  
  
  CONCLUSIONS
  Use of Intratect® for immunoglobulin substitution in primary and secondary immunodeficiency under real-life conditions is associated with a low rate of suspected ADRs. Serious ADRs are rare and manageable.
authors.forename: Artur
authors.initials: A
authors.lastname: Bauhofer
authors.forename: Roland L J
authors.initials: RL
authors.lastname: Dietrich
authors.forename: Rainer
authors.initials: R
authors.lastname: Schmeidl
mesh_terms: D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D005260:Female; D005858:Germany; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D007153:Immunologic Deficiency Syndromes / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors