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Immunogenicity of Hylan G-F 20 in Guinea Pigs and Mice
MASANORI SASAKI, TATSUYA MIYAZAKI, TAKEHIKO NAKAMURA, TOYOMI TAKAHASHI, SATOSHI MIYAUCHI, and HISASHI IWATA
ABSTRACT. Methods. Guinea pigs were subcutaneously immunized with hylan G-F 20 (Synvisc®) once a week for 3 weeks. After resting, these animals received an intradermal challenge with hylan to elicit allergic skin reactions. Animal sera were tested for the presence of hylan-specific antibodies by homologous passive cutaneous anaphylaxis (PCA) assay and of anti-hylan IgG by ELISA. Further, mice were similarly immunized with hylan, and their sera were analyzed by heterologous PCA assay in rats and by ELISA for anti-hylan Ig(G+M) and anti-hylan IgE. Results. In the guinea pig studies, acute and delayed erythematous skin reactions were elicited in immunized animals after the intradermal challenge with hylan. The sera of hylan-immunized guinea pigs showed positive reaction in the homologous PCA assay and significantly high amount of anti-hylan IgG, whereas the sera did not show any cross-reactivity against sodium hyaluronate. Hylan also exhibited immunogenicity in mice of 3 inbred strains, and C3H/HeN mice showed higher production of anti-hylan antibodies than Balb/c and C57BL/6 mice. Conclusion. Hylan G-F 20 exhibited immunogenicity in guinea pigs and mice. Recent reported severe acute inflammatory reactions in human patients after repeated intraarticular injections of hylan G-F 20 might involve product-specific, immune-mediated mechanisms. (J Rheumatol 2004;31:943-50) Key Indexing Terms:
HYLAN G-F 20
From the Central Research Laboratories, Seikagaku Corporation, Tokyo, Japan, and the Rheumatology and Joint Replacement Center, Nagoya Kyoritsu Hospital, Aichi, Japan. Dr. H. Iwata is a corporate advisor of Seikagaku Corporation. M. Sasaki, DVM; T. Miyazaki, MS; T. Nakamura, PhD; T. Takahashi, DVM, PhD; S. Miyauchi, PhD, Central Research Laboratories, Seikagaku Corporation; H. Iwata, MD, PhD, Emeritus Professor, Department of Orthopaedic Surgery, Nagoya University School of Medicine, and Director, Rheumatology and Joint Replacement Center, Nagoya Kyoritsu Hospital. Address reprint requests to Dr. M. Sasaki, Central Research Laboratories, Seikagaku Corporation, 3-1253 Tateno, Higashiyamato-shi, Tokyo 207-0021, Japan. E-mail: sasaki2@seikagaku.co.jp Submitted July 2, 2003; revision accepted November 4, 2003. |