TY - JOUR
T1 - Trajectory analyses to identify persistently low responders to COVID-19 vaccination in patients with inflammatory bowel disease
T2 - a prospective multicentre controlled study, J-COMBAT
AU - Watanabe, Kenji
AU - Nojima, Masanori
AU - Nakase, Hiroshi
AU - Sato, Toshiyuki
AU - Matsuura, Minoru
AU - Aoyama, Nobuo
AU - Kobayashi, Taku
AU - Sakuraba, Hirotake
AU - Nishishita, Masakazu
AU - Yokoyama, Kaoru
AU - Esaki, Motohiro
AU - Hirai, Fumihito
AU - Nagahori, Masakazu
AU - Nanjo, Sohachi
AU - Omori, Teppei
AU - Tanida, Satoshi
AU - Yokoyama, Yoshihiro
AU - Moriya, Kei
AU - Maemoto, Atsuo
AU - Handa, Osamu
AU - Ohmiya, Naoki
AU - Tsuchiya, Kiichiro
AU - Shinzaki, Shinichiro
AU - Kato, Shingo
AU - Uraoka, Toshio
AU - Tanaka, Hiroki
AU - Takatsu, Noritaka
AU - Nishida, Atsushi
AU - Umeno, Junji
AU - Nakamura, Masanao
AU - Mishima, Yoshiyuki
AU - Fujiya, Mikihiro
AU - Tsuchida, Kenji
AU - Hiraoka, Sakiko
AU - Okabe, Makoto
AU - Toyonaga, Takahiko
AU - Matsuoka, Katsuyoshi
AU - Andoh, Akira
AU - Hirota, Yoshio
AU - Hisamatsu, Tadakazu
N1 - Publisher Copyright:
© 2023, Japanese Society of Gastroenterology.
PY - 2023/10
Y1 - 2023/10
N2 - 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]α 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-TNFα 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. Graphical abstract: [Figure not available: see fulltext.]
AB - 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]α 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-TNFα 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. Graphical abstract: [Figure not available: see fulltext.]
KW - COVID-19
KW - Inflammatory bowel disease
KW - Responder
KW - Trajectory analyses
KW - Vaccine
UR - http://www.scopus.com/inward/record.url?scp=85167517010&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85167517010&partnerID=8YFLogxK
U2 - 10.1007/s00535-023-02029-z
DO - 10.1007/s00535-023-02029-z
M3 - Article
C2 - 37561155
AN - SCOPUS:85167517010
SN - 0944-1174
VL - 58
SP - 1015
EP - 1029
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
IS - 10
ER -
