Fcγ receptor 3B polymorphism is associated with hypersensitivity reactions to adalimumab in Japanese patients with rheumatoid arthritis

Abstract

Objectives: To examine the association between Fcγ receptor (FcγR) polymorphisms and the development of hypersensitivity reactions to adalimumab in patients with rheumatoid arthritis.

Methods: Sixty-five patients receiving adalimumab were enrolled in the study. Genetic polymorphisms for FcγR3B were genotyped in FCGR3B NA1/2 alleles by real allelic discrimination assay. Clinical information and the occurrence of a hypersensitivity reaction to adalimumab were collected from the patients’ charts.

Results: A hypersensitivity reaction was observed in 12% of the patients. Clinical information obtained from patients with a reaction and those without were the same. The FCGR3B NA1/NA1, NA1/NA2, and NA2/NA2 alleles were found in 75%, 13%, and 13% of the patients with hypersensitivity reaction, respectively, and in 28%, 42%, and 30% of those without a hypersensitivity reaction, respectively (p = 0.04). Multivariate logistic regression analysis identified only the NA1/NA1 as an independent relevant factor for a hypersensitivity reaction to adalimumab (OR 7.7, p = 0.01).

Conclusions: The FCGR3B NA1/NA1 genotype is associated with hypersensitivity reactions to adalimumab.

Keywords:

• Adalimumab
• Injection site reaction
• Polymorphism
• Rheumatoid arthritis

Acknowledgments

The authors sincerely thank Ms. Harumi Kondo and Ms. Mayumi Ota for helping with acquisition of clinical information.

Conflict of interest

MT, TO, and KY have no conflicts of interest to declare. HK received research grants from Abbvie GK, Astellas Pharma, Chugai Pharmaceutical Co., Ltd., Eisai Co. Ltd., Mitsubishi Tanabe Pharma Co., Nippon Kayaku Co. Ltd., Santen Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd.; speaking fees from AbbVie GK, Astellas Pharma, Bristol-Myers K.K., Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Nippon Kayaku Co. Ltd., Pfizer Japan Inc., Santen Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., and UCB Pharma; consultant fees from Eli Lilly Japan K.K., Novartis Pharma K.K., and Sanofi K.K. YK received lecture fees from Abbvie, Eisai Pharmaceutical, Chugai Pharmaceutical, Bristol-Myers Squibb, Astellas Pharmaceutical, Mitsubishi Tanabe Pharma Corporation, Pfizer, Janssen, and UCB. KS received research grants from Eisai Co., Ltd., and Bristol-Myers Squibb. TT received lecture fees or research grants from Abbott Japan Co., Ltd., Astellas Pharma, Bristol-Myers K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Sanofi-Aventis K.K., Santen Pharmaceutical Co., Ltd., Teijin Pharma Ltd., abbvie GK, Asahikasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Abbvie GK.

This work was partly supported by research grants from The Nakatomi Foundation, Japan.