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Abstract Number: 2160

Fcγ Receptor IIIb Polymorphism Is Associated with Injection Reaction to Adalimumab in Patients with Rheumatoid Arthritis

Masako Tsukamoto1, Yosuke Hashimoto1, Tatsuhiro Ohshige1, Keiko Yoshimoto2, Yuko Kaneko3, Hideto Kameda2 and Tsutomu Takeuchi4, 1Division of Rheumatology, Department of Internal medicine, Keio University School of Medicine, Tokyo, Japan, 2Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, 3Dept of Internal Medicine, Keio Univ School of Medicine, Shinjuku-ku, Japan, 4Keio University School of Medicine, Tokyo, Japan

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Adalimumab, adverse events and rheumatoid arthritis (RA), Fc receptors

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Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

Session Type: Abstract Submissions (ACR)

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.


Disclosure:

M. Tsukamoto,
None;

Y. Hashimoto,
None;

T. Ohshige,
None;

K. Yoshimoto,
None;

Y. Kaneko,
None;

H. Kameda,
None;

T. Takeuchi,

Abbott Japan Co., Ltd.,

2,

Astellas Pharma,

2,

Bristol-Myers K.K.,

2,

Chugai Pharmaceutical Co., Ltd,

2,

Daiichi Sankyo Co., Ltd.,

2,

Eisai Co., Ltd.,

2,

Janssen Pharmaceutical K.K.,

2,

Mitsubishi Tanabe Pharma Co.,

2,

Nippon Shinyaku Co., Ltd.,

2,

Otsuka Pharmaceutical,

2,

Pfizer Japan Inc. ,

2,

Sanofi-aventis K.K.,

2,

Santen Pharmaceutical Co.,Ltd. ,

2,

Takeda Pharmaceutical Co., Ltd. ,

2,

Teijin Pharma Ltd.,

3,

Abbott Japan Co., Ltd.,

5,

Bristol-Myers K.K.,

5,

Chugai Pharmaceutical Co., Ltd.,

5,

Eisai Co., Ltd.,

5,

Janssen Pharmaceutical K.K.,

5,

Mitsubishi Tanabe Pharma Co.,

5,

Pfizer Japan Inc.,

5,

Takeda Pharmaceutical Co., Ltd.,

5,

Astra Zeneca, K.K.,

5,

Eli-Lilly Japan K.K.,

5,

Novartis Pharma K.K.,

5,

Asahi Kasei Medical K.K,

5.

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