Safety monitoring of the intravenous immunoglobulin preparation Intratect® in primary and secondary immunodeficiencies: a prospective non-interventional study

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. 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. 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. 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..

Medienart:	Artikel

Erscheinungsjahr:	2015
Erschienen:	2015

Enthalten in:	Zur Gesamtaufnahme - volume:53
Enthalten in:	International journal of clinical pharmacology and therapeutics - 53(2015), 1, Seite 21

Sprache:	Englisch

Beteiligte Personen:	Bauhofer, Artur [VerfasserIn] Dietrich, Roland L J [Sonstige Person] Schmeidl, Rainer [Sonstige Person]

Links:	Volltext www.ncbi.nlm.nih.gov

Themen:	Immunoglobulins, Intravenous - administration & dosage Immunoglobulins, Intravenous - adverse effects Immunoglobulins, Intravenous - blood Immunologic Deficiency Syndromes - blood Immunologic Deficiency Syndromes - drug therapy Immunologic Deficiency Syndromes - immunology Immunologic Factors - administration & dosage Immunologic Factors - adverse effects Immunologic Factors - blood

doi:	10.5414/CP202204

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	OLC1962289117