Anti-integrin αvβ6 antibody as a biomarker for diagnosing ulcerative colitis: a nationwide multicenter validation study

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2024年11月28日

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Makoto Okabe,
Shuji Yamamoto,
Masahiro Shiokawa,
Tadakazu Hisamatsu,
Hajime Yamazaki,
Risa Nakanishi,
Kensuke Hamada,
Hiroki Kitamoto,
Takeshi Kuwada,
Norimitsu Uza,
Aki Sakatani,
Toshimitsu Fujii,
Masashi Ohno,
Minoru Matsuura,
Tomoyoshi Shibuya,
Naoki Ohmiya,
Makoto Ooi,
Namiko Hoshi,
Kei Moriya,
Kiichiro Tsuchiya,
Yoshiharu Yamaguchi,
Reiko Kunisaki,
Masahiro Takahara,
Tomohisa Takagi,
Tetsuo Takehara,
Fumihito Hirai,
Kazuki Kakimoto,
Motohiro Esaki,
Hiroshi Nakase,
Fukunori Kinjo,
Takehiro Torisu,
Shuji Kanmura,
Kazuyuki Narimatsu,
Katsuyoshi Matsuoka,
Hiroto Hiraga,
Kaoru Yokoyama,
Yusuke Honzawa,
Makoto Naganuma,
Masayuki Saruta,
Yuzo Kodama,
Tsutomu Chiba,
Hiroshi Seno

摘要

Background

A serum biomarker for diagnosing ulcerative colitis (UC) remains to be established. Although we recently reported an anti-integrin αvβ6 antibody (V6 Ab) for diagnosing UC with high sensitivity and specificity, no large-scale validation study exists. This study aimed to validate the diagnostic value of V6 Ab for UC using a nationwide multicenter cohort study.

Methods

We measured V6 Ab titers in patients definitively diagnosed with UC, Crohn’s disease (CD), or other gastrointestinal disorders (OGDs). The primary outcome was the diagnostic value of V6 Ab. Secondary outcomes were factors associated with false-negative results in patients with UC and false-positive results in patients without UC and the heterogeneity of the diagnostic value of V6 Ab among the participating facilities.

Results

We enrolled 1241, 796, and 206 patients with UC, CD, and OGD, respectively, from 28 Japanese high-volume referral centers. The diagnostic sensitivity of V6 Ab for UC was 87.7%, and its specificities for CD and OGDs were 82.0% and 87.4%, respectively. Multivariable logistic regression analysis showed that false-negative results were associated with older age at the time of sample collection, current smokers, lower partial Mayo score, and not receiving advanced therapies in patients with UC, and false-positive results were associated with colonic CD in patients with CD. No factor was associated with false-positive results in patients with OGDs. There were no significant differences in the diagnostic value of V6 Ab among the centers.

Conclusions

The diagnostic value of V6 Ab for UC was validated in the large-scale nationwide multicenter study.