Study characterises risk profile of intravenous immunoglobulin

0

“…characterize the risk profile of the intravenous immunoglobulin (IVIG) Intratect®” Bauhofer et al (2014).

References:

Bauhofer, A., Dietrich, R.L. and Schmeidl, R. (2014) Safety monitoring of the intravenous immunoglobulin preparation Intratect® in primary and secondary immunodeficiencies: a prospective non-interventional study. International Journal of Clinical Pharmacology and Therapeutics. October 27th. [epub ahead of print].

Abstract:

Objectives: 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.

Thank you to our partners for supporting IVTEAM

0%
0%
RATING

Now that you have read this item on IVTEAM why don't you help other visitors and choose a star rating for what you have read.

Share.

Comments are closed.

Free Email Updates
Join 5.5K IVTEAM members. Subscribe now and be the first to receive all the latest free updates from IVTEAM!
100% Privacy. We don't spam.