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

被引:1
|
作者
Okabe, Makoto [1 ]
Yamamoto, Shuji [1 ]
Shiokawa, Masahiro [1 ]
Hisamatsu, Tadakazu [1 ,2 ]
Yamazaki, Hajime [3 ]
Nakanishi, Risa [1 ]
Hamada, Kensuke [1 ]
Kitamoto, Hiroki [1 ]
Kuwada, Takeshi [1 ]
Uza, Norimitsu [1 ]
Sakatani, Aki [4 ]
Fujii, Toshimitsu [5 ]
Ohno, Masashi [6 ]
Matsuura, Minoru [2 ]
Shibuya, Tomoyoshi [7 ]
Ohmiya, Naoki [8 ]
Ooi, Makoto [9 ]
Hoshi, Namiko [9 ]
Moriya, Kei [10 ]
Tsuchiya, Kiichiro [11 ]
Yamaguchi, Yoshiharu [12 ]
Kunisaki, Reiko [13 ]
Takahara, Masahiro [14 ]
Takagi, Tomohisa [15 ]
Takehara, Tetsuo [16 ]
Hirai, Fumihito [17 ]
Kakimoto, Kazuki [18 ]
Esaki, Motohiro [19 ]
Nakase, Hiroshi [20 ]
Kinjo, Fukunori [21 ]
Torisu, Takehiro [22 ]
Kanmura, Shuji [23 ]
Narimatsu, Kazuyuki [24 ]
Matsuoka, Katsuyoshi [25 ]
Hiraga, Hiroto [26 ]
Yokoyama, Kaoru [27 ]
Honzawa, Yusuke [28 ]
Naganuma, Makoto [28 ]
Saruta, Masayuki [29 ]
Kodama, Yuzo [9 ]
Chiba, Tsutomu [30 ]
Seno, Hiroshi [1 ]
机构
[1] Kyoto Univ, Grad Sch Med, Dept Gastroenterol & Hepatol, 54 Shogoin Kawahara Cho,Sakyo Ku, Kyoto 6068507, Japan
[2] Kyorin Univ, Dept Gastroenterol & Hepatol, Sch Med, Mitaka, Tokyo 1818611, Japan
[3] Kyoto Univ, Grad Sch Med, Sect Clin Epidemiol, Dept Community Med, Kyoto 6068507, Japan
[4] Asahikawa Med Univ, Div Gastroenterol, Dept Internal Med, Asahikawa, Hokkaido 0788510, Japan
[5] Tokyo Med & Dent Univ, Dept Gastroenterol & Hepatol, Tokyo 1138519, Japan
[6] Shiga Univ Med Sci, Dept Med, Otsu, Shiga 5202192, Japan
[7] Juntendo Univ, Dept Gastroenterol, Sch Med, Tokyo 1138421, Japan
[8] Fujita Hlth Univ, Dept Adv Endoscopy, Sch Med, Toyoake, Aichi 4701192, Japan
[9] Kobe Univ, Grad Sch Med, Div Gastroenterol, Dept Internal Med, Kobe, Hyogo 6500017, Japan
[10] Nara Prefecture Gen Med Ctr, Dept Gastroenterol, Nara 6308581, Japan
[11] Univ Tsukuba, Inst Med, Dept Gastroenterol, Tsukuba, Ibaraki 3058576, Japan
[12] Aichi Med Univ, Sch Med, Dept Internal Med, Div Gastroenterol, Nagakute, Aichi 4801195, Japan
[13] Yokohama City Univ, Med Ctr, Inflammatory Bowel Dis Ctr, Yokohama, Kanagawa 2320024, Japan
[14] Okayama Univ, Grad Sch Med, Dept Gastroenterol & Hepatol Dent & Pharmaceut Sc, Okayama 7008558, Japan
[15] Kyoto Prefectural Univ Med, Dept Mol Gastroenterol & Hepatol, Kyoto 6028566, Japan
[16] Osaka Univ, Grad Sch Med, Dept Gastroenterol & Hepatol, Suita, Osaka 5650871, Japan
[17] Fukuoka Univ, Fac Med, Dept Gastroenterol, Fukuoka 8140180, Japan
[18] Osaka Med & Pharmaceut Univ, Dept Internal Med 2, Takatsuki, Osaka 5698686, Japan
[19] Saga Univ, Fac Med, Dept Internal Med, Div Gastroenterol, Saga 8498501, Japan
[20] Sapporo Med Univ, Sch Med, Dept Gastroenterol & Hepatol, Sapporo, Hokkaido 0608543, Japan
[21] Urasoe Gen Hosp, Ctr Gastroenterol, Urasoe 9012102, Japan
[22] Kyushu Univ, Grad Sch Med Sci, Dept Med & Clin Sci, Fukuoka 8128582, Japan
[23] Kagoshima Univ, Grad Sch Med & Dent Sci, Div Digest & Lifestyle Dis, Kagoshima 8908520, Japan
[24] Natl Def Med Coll, Dept Internal Med, Tokorozawa, Saitama 3598513, Japan
[25] Toho Univ, Sakura Med Ctr, Dept Internal Med, Div Gastroenterol & Hepatol, Sakura, Chiba 2858741, Japan
[26] Hirosaki Univ, Grad Sch Med, Dept Gastroenterol & Hematol, Hirosaki, Aomori 0368563, Japan
[27] Kitasato Univ, Sch Med, Dept Gastroenterol, Sagamihara, Kanagawa 2520375, Japan
[28] Kansai Med Univ, Dept Internal Med 3, Div Gastroenterol & Hepatol, Osaka 5731010, Japan
[29] Jikei Univ, Sch Med, Dept Gastroenterol & Hepatol, Div Internal Med, Tokyo 1058471, Japan
[30] Kansai Elect Power Hosp, Dept Gastroenterol & Hepatol, Fukushima Ku, Osaka 5530003, Japan
关键词
Anti-integrin alpha v beta 6 antibody; Ulcerative colitis; Colonic Crohn's disease; Diagnostic biomarker; INFLAMMATORY-BOWEL-DISEASE; CROHNS-DISEASE;
D O I
10.1007/s00535-024-02176-x
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background A serum biomarker for diagnosing ulcerative colitis (UC) remains to be established. Although we recently reported an anti-integrin alpha v beta 6 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. MethodsWe 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. ResultsWe 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. ConclusionsThe diagnostic value of V6 Ab for UC was validated in the large-scale nationwide multicenter study.
引用
收藏
页码:86 / 95
页数:10
相关论文
共 28 条
  • [21] Anti-TL1A Antibody PF-06480605 Safety and Efficacy for Ulcerative Colitis: A Phase 2a Single-Arm Study
    Danese, Silvio
    Klopocka, Maria
    Scherl, Ellen J.
    Romatowski, Jacek
    Allegretti, Jessica R.
    Peeva, Elena
    Vincent, Michael S.
    Schoenbeck, Uwe
    Ye, Zhan
    Hassan-Zahraee, Mina
    Rath, Natalie
    Li, Gang
    Neelakantan, Srividya
    Banfield, Christopher
    Lepsy, Christopher
    Chandra, Deepa E.
    Hung, Kenneth E.
    CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 2021, 19 (11) : 2324 - +
  • [22] Sustained effect of leukocytapheresis/granulocytapheresis versus anti-human TNF-α monoclonal antibody on ulcerative colitis: A 2-year retrospective study
    Sakai, Masahiro
    Hayashi, Koichi
    Ito, Tomoyuki
    Otani, Haruka
    Mori, Yuya
    Ito, Shinsuke
    Endo, Keita
    Matsuda, Hiroto
    Yoshino, Kaede
    Kitamura, Koichi
    Kubota, Eiji
    Motomura, Yasuaki
    Suzuki, Yasuhiro
    Fujitani, Shigeki
    Suzuki, Toshihiko
    MEDICINE, 2023, 102 (16) : E33368
  • [23] Long-term Safety and Efficacy of the Anti-MAdCAM-1 Monoclonal Antibody Ontamalimab [SHP647] for the Treatment of Ulcerative Colitis: The Open-label Study TURANDOT II
    Reinisch, Walter
    Sandborn, William J.
    Danese, Silvio
    Hebuterne, Xavier
    Klopocka, Maria
    Tarabar, Dino
    Vanasek, Tomas
    Gregus, Milos
    Hellstern, Paul A.
    Kim, Joo Sung
    Sparrow, Miles P.
    Gorelick, Kenneth J.
    Hoy, Michael
    Goetsch, Martina
    Bliss, Caleb
    Gupta, Charu
    Cataldi, Fabio
    Vermeire, Severine
    JOURNAL OF CROHNS & COLITIS, 2021, 15 (06) : 938 - 949
  • [24] Randomized, Ascending Dose, Phase 2 Study of KHK4083, an Anti-OX40 Monoclonal Antibody, in Moderately Active Ulcerative Colitis
    Kierkus, Jaroslaw
    Pesegova, Marina
    Klopocka, Maria
    Brankovic, Marija
    Kasai, Noriyuki
    Efuni, Sergey
    Kong, Jennifer
    Nakajima, Yu
    Jordan, Christina
    Matsui, Takeshi
    Feagan, Brian G.
    Strout, Vincent
    CROHNS & COLITIS 360, 2020, 2 (03) : 1 - 10
  • [25] The impact of anti-TNFα therapy on colectomy rates and corticosteroid treatment among 3001 paediatric and adolescent patients with ulcerative colitis-a nationwide study from 1995 to 2015
    Lund, Ken
    Larsen, Michael Due
    Knudsen, Torben
    Kjeldsen, Jens
    Nielsen, Rasmus Gaardskjaer
    Norgard, Bente Mertz
    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2019, 50 (10) : 1077 - 1085
  • [26] Long-Term Efficacy and Safety of Cyclosporine in a Cohort of Steroid-Refractory Acute Severe Ulcerative Colitis Patients from the ENEIDA Registry (1989-2013): A Nationwide Multicenter Study
    Ordas, I.
    Domenech, E.
    Manosa, M.
    Garcia-Sanchez, V.
    Iglesias-Flores, E.
    Penalva, M.
    Canas-Ventura, A.
    Merino, O.
    Fernandez-Banares, F.
    Gomollon, F.
    Vera, M.
    Gutierrez, A.
    Garcia-Planella, E.
    Chaparro, M.
    Aguas, M.
    Gento, E.
    Munoz, F.
    Aguirresarobe, M.
    Munoz, C.
    Fernandez, L.
    Calvet, X.
    Jimenez, C. E.
    Montoro, M. A.
    Mir, A.
    De Castro, M. L.
    Garcia-Sepulcre, M. F.
    Bermejo, F.
    Panes, J.
    Esteve, M.
    AMERICAN JOURNAL OF GASTROENTEROLOGY, 2017, 112 (11) : 1709 - 1718
  • [27] Randomised clinical trial: a phase 1, dose-ranging study of the anti-matrix metalloproteinase-9 monoclonal antibody GS-5745 versus placebo for ulcerative colitis
    Sandborn, W. J.
    Bhandari, B. R.
    Fogel, R.
    Onken, J.
    Yen, E.
    Zhao, X.
    Jiang, Z.
    Ge, D.
    Xin, Y.
    Ye, Z.
    French, D.
    Silverman, J. A.
    Kanwar, B.
    Subramanian, G. M.
    McHutchison, J. G.
    Lee, S. D.
    Shackelton, L. M.
    Pai, R. K.
    Levesque, B. G.
    Feagan, B. G.
    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2016, 44 (02) : 157 - 169
  • [28] Add-on multiple submucosal injections of the RNA oligonucleotide GUT-1 to anti-TNF antibody treatment in patients with moderate-to-severe ulcerative colitis: an open-label, proof-of concept study
    Suzuki, Kenji
    Sameshima, Yukinori
    Yokoyama, Junji
    Terai, Shuji
    Yoneyama, Hiroyuki
    Atreya, Raja
    Neurath, Markus F.
    Hibi, Toshifumi
    Asakura, Hitoshi
    INFLAMMATION AND REGENERATION, 2024, 44 (01)