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Ann Rheum Dis. 2017 Jul;76(7):1285-1288. doi: 10.1136/annrheumdis-2016-211035. Epub 2017 Apr 28.

Infusion reactions during infliximab treatment are not associated with IgE anti-infliximab antibodies.

Author information

1
Department of Immunopathology, Sanquin Research Landsteiner Laboratory, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
2
Department of Rheumatology, Hospital La Paz, Madrid, Spain.
3
Immunology Unit, IdiPAZ, RIER, Hospital La Paz, Madrid, Spain.
4
Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam, The Netherlands.
5
Jan van Breemen Research Institute | Reade, Amsterdam, The Netherlands.

Abstract

OBJECTIVES:

Controversy exists on the role of IgE antidrug antibodies (IgE-ADA) in infusion reactions (IR) on infliximab treatment, partly due to the lack of a positive control used for assay validation. We sought to (1) develop a robust assay to measure IgE-ADA, including a positive control, (2) determine the association between IgE-ADA and IR and (3) determine the incidence of IgE-ADA in infliximab treated patients.

METHODS:

A recombinant human IgE anti-infliximab monoclonal antibody was developed as standard and positive control. With this antibody, we set up a novel robust assay to measure IgE-ADA. IgE-ADA was determined in three retrospective cohorts (n=159) containing IR+ (n=37) and IR- (n=39), and longitudinal sera of 83 spondyloarthritis.

RESULTS:

IgE-ADA was found in 0/39 IR-, whereas 4/37 (11%) IR+ showed low levels (0.1-0.3 IU/mL, below the 0.35 IU/mL threshold associated with elevated risk of allergic symptoms). All patients who were IgE-ADA positive also had (very) high IgG-ADA levels. The incidence of IgE-ADA in patients with infliximab-treated spondyloarthritis was estimated at less than approximately 1%.

CONCLUSIONS:

IgE-ADA is rarely detected in infliximab-treated patients. Moreover, the absence of IgE-ADA in the majority of IR+ patients suggests that IgE-ADA is not associated with infusion reactions.

KEYWORDS:

Anti-TNF; Rheumatoid Arthritis; Spondyloarthritis

PMID:
28455438
DOI:
10.1136/annrheumdis-2016-211035
[Indexed for MEDLINE]

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