Anti-integrin αvβ6 autoantibody in primary sclerosing cholangitis: a Japanese nationwide study

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2024年11月16日

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Muneji Yasuda,
Masahiro Shiokawa,
Takeshi Kuwada,
Yoshihiro Nishikawa,
Risa Nakanishi,
Ikuhisa Takimoto,
Koki Chikugo,
Masataka Yokode,
Yuya Muramoto,
Shimpei Matsumoto,
Takeharu Nakamura,
Sakiko Ota,
Tomoaki Matsumori,
Keiko Kuroda,
Takahisa Hachiya,
Hajime Yamazaki,
Norimitsu Uza,
Yuzo Kodama,
Tsutomu Chiba,
Toshio Fujisawa,
Atsumasa Komori,
Masanori Abe,
Izumi Yamaguchi,
Fumihiko Matsuda,
Hiroyuki Isayama,
Atsushi Tanaka,
Hiroshi Seno

摘要

Background

Although specific biomarkers for primary sclerosing cholangitis (PSC) are required, no such biomarkers have been identified. We previously reported that patients with PSC had anti-integrin αvβ6 autoantibodies at only two hospitals. In this study, we aimed to validate the accuracy of the autoantibodies in diagnosing PSC using the newly developed Anti-integrin αvβ6 enzyme-linked immunosorbent assay (ELISA) Kit, which enables quantitation and comparison of antibodies among different facilities.

Methods

Overall, 81 patients with PSC in a Japanese PSC registry recruited from 17 medical centers and hospitals, and 358 controls were enrolled. We retrospectively assessed anti-integrin αvβ6 autoantibodies using the Anti-integrin αvβ6 ELISA Kit and in-house ELISA.

Results

Anti-Integrin αvβ6 ELISA Kit and in-house ELISA exhibited a significant correlation (r = 0.97, P < 0.001). Anti-integrin αvβ6 autoantibodies were detected in 67 of 81 (82.7%) patients with PSC and 20 of 358 (5.6%) controls, resulting in a sensitivity of 82.7% and specificity of 94.4% for PSC, using the anti-integrin αvβ6 ELISA Kit. When focusing on the presence or absence of inflammatory bowel disease (IBD), the sensitivities for PSC with ulcerative colitis, Crohn’s disease, unclassified-IBD, and without IBD were 97.8% (43/44), 100% (1/1), 80.0% (8/10), and 53.8% (7/13), respectively. Antibody concentrations were significantly higher in PSC patients without IBD than in controls (P < 0.001).

Conclusions

We validated that anti-integrin αvβ6 autoantibodies have high sensitivity and specificity for diagnosing PSC. This study provides further evidence that anti-integrin αvβ6 autoantibodies are a useful biomarker for diagnosing PSC.