Delayed Infusion Reactions to Enzyme Replacement Therapies.

JIMD Rep 2017 25;34:63-70. Epub 2016 Aug 25.

Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.

Background: There are currently ten intravenous enzyme replacement therapy (ERT) products available for the treatment of eight different lysosomal diseases (LD) in the USA. Additional ERT products are in clinical trials. The most common ERT adverse events are infusion reactions (IR). While IR are often defined as hypersensitivity or anaphylactoid reactions occurring concurrently with (i.e., during) infusion administration (CIR), there exists the potential for delayed infusion reactions (DIR), which present after completion of infusion administration.

Hypothesis: Concurrent infusion reactions (CIR) are not the only infusion reactions associated with enzyme therapy.

Methods: This study evaluated the occurrence of infusion reactions in 46 patients with LD who had received ERT for a minimum of 2 years. Infusion reactions were evaluated according to symptoms, time of onset, and duration of reactions. The frequency of infusion reactions with each ERT product was compared to that reported in the FDA-approved product package insert.

Results And Conclusions: In this study, DIR were observed and occurred as often as CIR in the study population, despite not being characterized or reported in most ERT product package inserts. Effective methods for managing DIR and CIR differed, thus emphasizing the importance of monitoring for both types of infusion reactions in order to optimize outcomes for patients using ERT.

Download full-text PDF

Source
http://dx.doi.org/10.1007/8904_2016_8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5509557PMC
August 2016

Publication Analysis

Top Keywords

infusion reactions
36
reactions
11
infusion
10
enzyme replacement
8
ert product
8
product package
8
delayed infusion
8
ert products
8
ert
7
package insertresults
4
dir completion
4
fda-approved product
4
concurrent infusion
4
reactions cir
4
administrationhypothesis concurrent
4
reactions dir
4
infusion administrationhypothesis
4
completion infusion
4
conclusions study
4
dir observed
4

Similar Publications