Trajectory analyses to identify persistently low responders to COVID-19 vaccination in patients with inflammatory bowel disease: a prospective multicentre controlled study, J-COMBAT

被引：3

作者：

Watanabe, Kenji ^{[1
,2
]}

Nojima, Masanori ^{[3
]}

Nakase, Hiroshi ^{[4
]}

Sato, Toshiyuki ^{[1
]}

Matsuura, Minoru ^{[5
]}

Aoyama, Nobuo ^{[6
]}

Kobayashi, Taku ^{[7
]}

Sakuraba, Hirotake ^{[8
]}

Nishishita, Masakazu ^{[9
]}

Yokoyama, Kaoru ^{[10
]}

Esaki, Motohiro ^{[11
]}

Hirai, Fumihito ^{[12
]}

Nagahori, Masakazu ^{[13
]}

Nanjo, Sohachi ^{[14
]}

Omori, Teppei ^{[15
]}

Tanida, Satoshi ^{[16
]}

Yokoyama, Yoshihiro ^{[4
]}

Moriya, Kei ^{[17
]}

Maemoto, Atsuo ^{[18
]}

Handa, Osamu ^{[19
]}

Ohmiya, Naoki ^{[20
]}

Tsuchiya, Kiichiro ^{[21
]}

Shinzaki, Shinichiro ^{[1
,22
]}

Kato, Shingo ^{[23
]}

Uraoka, Toshio ^{[24
]}

Tanaka, Hiroki ^{[25
]}

Takatsu, Noritaka ^{[26
]}

Nishida, Atsushi ^{[27
]}

Umeno, Junji ^{[28
]}

Nakamura, Masanao ^{[29
]}

Mishima, Yoshiyuki ^{[30
]}

Fujiya, Mikihiro ^{[31
]}

Tsuchida, Kenji ^{[32
]}

Hiraoka, Sakiko ^{[33
]}

Okabe, Makoto ^{[34
]}

Toyonaga, Takahiko ^{[35
]}

Matsuoka, Katsuyoshi ^{[36
]}

Andoh, Akira ^{[27
]}

Hirota, Yoshio ^{[37
]}

Hisamatsu, Tadakazu ^{[5
]}

J COMBAT Study Grp

机构：

[1] Hyogo Med Univ, Dept Internal Med, Div Gastroenterol & Hepatol, 1-1 Mukogawa Cho, Nishinomiya, Hyogo, Japan

[2] Univ Toyama, Dept Internal Med Inflammatory Bowel Dis, 2630 Sugitani, Toyama 9300194, Japan

[3] Univ Tokyo, Inst Med Sci Hosp, Ctr Translat Res, 4-6-1 Shirokanedai,Minato Ku, Tokyo, Japan

[4] Sapporo Med Univ, Dept Gastroenterol & Hepatol, Sch Med, S-1,W-16,Chuo Ku, Sapporo, Japan

[5] Kyorin Univ, Dept Gastroenterol & Hepatol, Sch Med, Shinkawa 6-20-2, Mitaka, Tokyo, Japan

[6] Aoyama Clin, 3-3-9 Tamondouri, Kobe, Japan

[7] Kitasato Univ, Ctr Adv IBD Res & Treatment, Dept Gastroenterol, Kitasato Inst Hosp, 5-9-1 Shirokane,Minato Ku, Tokyo, Japan

[8] Hirosaki Univ, Dept Gastroenterol & Hematol, Grad Sch Med, 5 Zaifu Cho, Hirosaki, Aomori, Japan

[9] Nishishita Gastrointestinal Hosp, 4-15 Kitakawahori Cho,Tennoji Ku, Osaka, Japan

[10] Kitasato Univ Sch Med, Dept Gastroenterol, Kitasato 1-15-1,Minami Ku, Sagamihara, Kanagawa, Japan

[11] Saga Univ, Fac Med, Dept Internal Med, Div Gastroenterol, 1-1 5 Chome, Nabeshima, Saga, Japan

[12] Fukuoka Univ, Fac Med, Dept Gastroenterol & Med, 7-45-1 Nanakuma,Jonan Ku, Fukuoka, Japan

[13] Tokyo Med & Dent Univ Hosp, Clin Res Ctr, 1-5-45 Yushima Bunkyo Ku, Tokyo, Japan

[14] Univ Toyama, Dept Internal Med 3, 2630 Sugitani, Toyama, Toyama, Japan

[15] Tokyo Womens Med Univ, Inst Gastroenterol, 8-1 Kawada Cho,Shinju Ku, Tokyo, Japan

[16] Nagoya City Univ, Educ & Res Ctr Community Med, Grad Sch Med Sci, 1 Kawasumi,Mizuho Cho,Mizuho Ku, Nagoya, Japan

[17] Nara Med Univ, Dept Gastroenterol, 840 Shijo Cho, Kashihara, Nara, Japan

[18] Sapporo Higashi Tokushukai Hosp, IBD Ctr, 3-1 Kita 33 Jo Higashi 14 Chome,Higashi Ku, Sapporo, Japan

[19] Kawasaki Med Sch, Dept Internal Med, Div Gastroenterol, 577 Matsushima, Kurashiki, Okayama, Japan

[20] Fujita Hlth Univ, Dept Adv Endoscopy, Sch Med, 1-98 Dengakugakubo,Kutsukake Cho, Toyoake, Aichi, Japan

[21] Univ Tsukuba, Fac Med, Dept Gastroenterol, 1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan

[22] Osaka Univ, Dept Gastroenterol & Hepatol, Grad Sch Med, 2-2 Yamadaoka, Suita, Osaka, Japan

[23] Saitama Med Univ, Saitama Med Ctr, Dept Gastroenterol & Hepatol, 1981 Kamoda, Kawagoe, Saitama, Japan

[24] Gunma Univ, Dept Gastroenterol & Hepatol, Grad Sch Med, 3-39-22 Showa Machi, Maebashi, Gunma, Japan

[25] Sapporo IBD Clin, 1-18 Minami 19,Nishi 8,Chuo Ku, Sapporo, Hokkaido, Japan

[26] Fukuoka Univ, Inflammatory Bowel Dis Ctr, Chikushi Hosp, 1-1-1 Zokumyoin, Fukuoka, Japan

[27] Shiga Univ Med Sci, Dept Med, Seta Tsukinowa Cho, Otsu, Shiga, Japan

[28] Kyushu Univ, Grad Sch Med Sci, Dept Med & Clin Sci, 3-1-1 Maidashi,Higashi Ku, Fukuoka, Japan

[29] Nagoya Univ Hosp, Dept Endoscopy, 65 Tsurumai Cho,Showa Ku, Nagoya, Japan

[30] Shimane Univ, Fac Med, Dept Internal Med 2, 1060 Nishikawatsu Cho, Matsue, Shimane, Japan

[31] Asahikawa Med Univ, Dept Med, Div Metab & Biosyst Sci Gastroenterol & Hematol On, Gastroenterol & Endoscopy, 2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, Japan

[32] Nagoya City Univ, Gastroenterol, West Med Ctr, 1-1-1 Hirate Cho,Kita Ku, Nagoya, Aichi, Japan

[33] Okayama Univ, Dept Gastroenterol & Hepatol, Dent & Pharmaceut Sci, Grad Sch Med, 2-5-1 Shikata Cho,Kita Ku, Okayama, Japan

[34] Kyoto Univ, Grad Sch Med, Dept Gastroenterol & Hepatol, Yoshida Konoe Cho,Sakyo Ku, Kyoto, Japan

[35] Jikei Univ, Dept Gastroenterol & Hepatol, Div Internal Med, Sch Med, 3-19-18 Nishi Shimbashi,Minato Ku, Tokyo, Japan

[36] Toho Univ Sakura Med Ctr, Dept Internal Med, Div Gastroenterol & Hepatol, Shimoshidu, 564-1, Chiba, Japan

[37] SOUSEIKAI Med Grp Medical Co LTA, Clin Epidemiol Res Ctr, 3-6-1 Kashii Teriha,Higashi Ku, Fukuoka, Japan

来源：

JOURNAL OF GASTROENTEROLOGY | 2023年 / 58卷 / 10期

关键词：

COVID-19; Vaccine; Inflammatory bowel disease; Trajectory analyses; Responder;

D O I：

10.1007/s00535-023-02029-z

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background The degree of immune response to COVID-19 vaccination in inflammatory bowel disease (IBD) patients based on actual changes in anti-SARS-CoV-2 antibody titres over time is unknown.Methods Data were prospectively acquired at four predetermined time points before and after two vaccine doses in a multicentre observational controlled study. The primary outcome was humoral immune response and vaccination safety in IBD patients. We performed trajectory analysis to identify the degree of immune response and associated factors in IBD patients compared with controls.Results Overall, 645 IBD patients and 199 control participants were analysed. At 3 months after the second vaccination, the seronegative proportions were 20.3% (combination of anti-tumour necrosis factor [TNF]a and thiopurine) and 70.0% (triple combination including steroids), despite that 80.0% receiving the triple combination therapy were seropositive at 4 weeks after the second vaccination. Trajectory analyses indicated three degrees of change in immune response over time in IBD patients: high (57.7%), medium (35.6%), and persistently low (6.7%). In the control group, there was only one degree, which corresponded with IBD high responders. Older age, combined anti-TNFa and thiopurine (odds ratio [OR], 37.68; 95% confidence interval [CI], 5.64-251.54), steroids (OR, 21.47; 95%CI, 5.47-84.26), and tofacitinib (OR, 10.66; 95%CI, 1.49-76.31) were factors associated with persistently low response. Allergy history (OR, 0.17; 95%CI, 0.04-0.68) was a negatively associated factor. Adverse reactions after the second vaccination were significantly fewer in IBD than controls (31.0% vs 59.8%; p < 0.001).Conclusions Most IBD patients showed a sufficient immune response to COVID-19 vaccination regardless of clinical factors. Assessment of changes over time is essential to optimize COVID-19 vaccination, especially in persistently low responders.

引用

页码：1015 / 1029

页数：15

共 24 条

[1] COVID-19 vaccine-induced antibody responses in immunosuppressed patients with inflammatory bowel disease (VIP): a multicentre, prospective, case-control study [J].

Alexander, James L. ;

Kennedy, Nicholas A. ;

Ibraheim, Hajir ;

Anandabaskaran, Sulak ;

Saifuddin, Aamir ;

Seoane, Rocio Castro ;

Liu, Zhigang ;

Nice, Rachel ;

Bewshea, Claire ;

D'Mello, Andrea ;

Constable, Laura ;

Jones, Gareth R. ;

Balarajah, Sharmili ;

Fiorentino, Francesca ;

Sebastian, Shaji ;

Irving, Peter M. ;

Hicks, Lucy C. ;

Williams, Horace R. T. ;

Kent, Alexandra J. ;

Linger, Rachel ;

Parkes, Miles ;

Kok, Klaartje ;

Patel, Kamal, V ;

Teare, Julian P. ;

Altmann, Daniel M. ;

Boyton, Rosemary J. ;

Goodhand, James R. ;

Hart, Ailsa L. ;

Lees, Charlie W. ;

Ahmad, Tariq ;

Powell, Nick .

LANCET GASTROENTEROLOGY & HEPATOLOGY, 2022, 7 (04) :342-352

[2] A predictive model to estimate fever after receipt of the second dose of Pfizer-BioNTech coronavirus disease 2019 vaccine: An observational cohort study [J].

Chiba, Satoru ;

Shinohara, Kaoru .

HEALTH SCIENCE REPORTS, 2022, 5 (04)

[3] Management of IBD during the COVID-19 outbreak: resetting clinical priorities [J].

Danese, Silvio ;

Cecconi, Maurizio ;

Spinelli, Antonino .

NATURE REVIEWS GASTROENTEROLOGY & HEPATOLOGY, 2020, 17 (05) :253-255

[4]

Food and Drug Administration, healthy adult and adolescent volunteers enrolled in preventive

[5]

Hayashi Yuki, 2022, Gastroenterology, V163, P338, DOI 10.1053/j.gastro.2022.03.008

[6] Clinical validation of the Siemens quantitative SARS-CoV-2 spike IgG assay (sCOVG) reveals improved sensitivity and a good correlation with virus neutralization titers [J].

Irsara, Christian ;

Egger, Alexander E. ;

Prokop, Wolfgang ;

Nairz, Manfred ;

Loacker, Lorin ;

Sahanic, Sabina ;

Pizzini, Alex ;

Sonnweber, Thomas ;

Holzer, Barbara ;

Mayer, Wolfgang ;

Schennach, Harald ;

Loeffler-Ragg, Judith ;

Bellmann-Weiler, Rosa ;

Hartmann, Boris ;

Tancevski, Ivan ;

Weiss, Gunter ;

Binder, Christoph J. ;

Anliker, Markus ;

Griesmacher, Andrea ;

Hoermann, Gregor .

CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2021, 59 (08) :1453-1462

[7] Trajectory of Viral RNA Load Among Persons With Incident SARS-CoV-2 G614 Infection (Wuhan Strain) in Association With COVID-19 Symptom Onset and Severity [J].

Karita, Helen C. Stankiewicz ;

Dong, Tracy Q. ;

Johnston, Christine ;

Neuzil, Kathleen M. ;

Paasche-Orlow, Michael K. ;

Kissinger, Patricia J. ;

Bershteyn, Anna ;

Thorpe, Lorna E. ;

Deming, Meagan ;

Kottkamp, Angelica ;

Laufer, Miriam ;

Landovitz, Raphael J. ;

Luk, Alfred ;

Hoffman, Risa ;

Roychoudhury, Pavitra ;

Magaret, Craig A. ;

Greninger, Alexander L. ;

Huang, Meei-Li ;

Jerome, Keith R. ;

Wener, Mark ;

Celum, Connie ;

Chu, Helen Y. ;

Baeten, Jared M. ;

Wald, Anna ;

Barnabas, Ruanne, V ;

Brown, Elizabeth R. .

JAMA NETWORK OPEN, 2022, 5 (01) :E2142796

[8] Infliximab is associated with attenuated immunogenicity to BNT162b2 and ChAdOx1 nCoV-19 SARS-CoV-2 vaccines in patients with IBD [J].

Kennedy, Nicholas A. ;

Lin, Simeng ;

Goodhand, James R. ;

Chanchlani, Neil ;

Hamilton, Benjamin ;

Bewshea, Claire ;

Nice, Rachel ;

Chee, Desmond ;

Cummings, J. R. Fraser ;

Fraser, Aileen ;

Irving, Peter M. ;

Kamperidis, Nikolaos ;

Kok, Klaartje B. ;

Lamb, Christopher Andrew ;

Macdonald, Jonathan ;

Mehta, Shameer ;

Pollok, Richard C. G. ;

Raine, Tim ;

Smith, Philip J. ;

Verma, Ajay Mark ;

Jochum, Simon ;

McDonald, Timothy J. ;

Sebastian, Shaji ;

Lees, Charlie W. ;

Powell, Nick ;

Ahmad, Tariq .

GUT, 2021, 70 (10) :1884-1893

[9] COVID-19 Vaccine Is Effective in Inflammatory Bowel Disease Patients and Is Not Associated With Disease Exacerbation [J].

Lev-Tzion, Raffi ;

Focht, Gili ;

Lujan, Rona ;

Mendelovici, Adi ;

Friss, Chagit ;

Greenfeld, Shira ;

Kariv, Revital ;

Ben-Tov, Amir ;

Matz, Eran ;

Nevo, Daniel ;

Barak-Corren, Yuval ;

Dotan, Iris ;

Turner, Dan .

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 2022, 20 (06) :E1263-E1282

[10] Antibody decay, T cell immunity and breakthrough infections following two SARS-CoV-2 vaccine doses in inflammatory bowel disease patients treated with infliximab and vedolizumab [J].

Lin, Simeng ;

Kennedy, Nicholas A. ;

Saifuddin, Aamir ;

Sandoval, Diana Munoz ;

Reynolds, Catherine J. ;

Seoane, Rocio Castro ;

Kottoor, Sherine H. ;

Pieper, Franziska P. ;

Lin, Kai-Min ;

Butler, David K. ;

Chanchlani, Neil ;

Nice, Rachel ;

Chee, Desmond ;

Bewshea, Claire ;

Janjua, Malik ;

McDonald, Timothy J. ;

Sebastian, Shaji ;

Alexander, James L. ;

Constable, Laura ;

Lee, James C. ;

Murray, Charles D. ;

Hart, Ailsa L. ;

Irving, Peter M. ;

Jones, Gareth-Rhys ;

Kok, Klaartje B. ;

Lamb, Christopher A. ;

Lees, Charlie W. ;

Altmann, Daniel M. ;

Boyton, Rosemary J. ;

Goodhand, James R. ;

Powell, Nick ;

Ahmad, Tariq .

NATURE COMMUNICATIONS, 2022, 13 (01)

← 1 2 3 →