Background/Purpose: Biological agents targeting a specific molecule provide an effective means for therapeutic management of rheumatoid arthritis (RA), but infusion/injection reaction is a major adverse event in patients with RA treated with biological agents. We previously reported that a high affinity Fcγ receptor (FcγR) IIIB polymorphism (NA1/NA1) is an independent risk factor for the development of infusion reaction to infliximab in RA patients (Ann Rheum Dis 70:299,2011). In this study, we investigated whether FcγR IIIB polymorphisms are related with injection reaction to adalimumab (ADA), a fully human anti-TNFα monoclonal antibody in patients with RA.

Methods: Consecutive patients with RA who fulfilled the 1987 revised criteria of the American College of Rheumatology (ACR) for the classification of RA or the 2010 ACR/EULAR RA Classification Criteria were invited to participate in the study after informed consent. Peripheral blood samples and clinical records were obtained from 65 RA patients (56 females and 9 males) treated with ADA between July 2008 and May 2012. The genomic DNA was extracted from peripheral blood mononuclear cells. Genetic polymorphisms for FcγR IIIB were genotyped in FCGR3B NA1/2 alleles by real allelic discrimination assay. Clinical records in 65 patients were collected retrospectively. Genetic polymorphisms were subjected to logistic regression analysis to evaluate the association with clinical parameters.

Results:

Injection reaction to ADA was observed in 8 patients, 2 patients of those discontinued ADA due to those injection reactions. There was no significant difference in clinical background between patients with injection reaction and those without. The FCGR3B NA1/NA1 genotype was found in 75.0% (6/8) of the patients with injection reaction whereas in only 28.1% (16/57) of those without injection reaction, indicating that this genotype is associated with the development of infusion reactions. In contrast, the genotypes NA1/NA2 and NA2/NA2 were only observed in 12.5% and 12.5% of the patients with injection reaction while in 42.1% and 29.8% of those without injection reaction. Analyses confirmed that the distribution of the FCGR3B genotypes between patients with and without injection reactions was significantly different (p=0.022). On the other hand, any clinical parameters tested in this study were not associated with injection reaction.

Conclusion: The FCGR3B NA1/NA1 genotype may be the potential predictive marker for the development of injection reaction to ADA as well as infusion reaction to infliximab in Japanese RA patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/fc%ce%b3-receptor-iiib-polymorphism-is-associated-with-injection-reaction-to-adalimumab-in-patients-with-rheumatoid-arthritis/