Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Mar 16, 2022; 14(3): 153-162
Published online Mar 16, 2022. doi: 10.4253/wjge.v14.i3.153
SARS-CoV-2 in inflammatory bowel disease population: Antibodies, disease and correlation with therapy
Clara Benedetta Conti, Elsa Mainardi, Sara Soro, Sophie Testa, Annalisa De Silvestri, Andrea Drago, Fabrizio Cereatti, Roberto Grassia
Clara Benedetta Conti, Sara Soro, Andrea Drago, Fabrizio Cereatti, Roberto Grassia, Department of Gastroenterology and Digestive Endoscopy, ASST Cremona, Cremona 26100, Italy
Elsa Mainardi, Sophie Testa, Department of Laboratory Medicine, Haemostasis and Thrombosis Center, ASST Cremona, Cremona 26100, Italy
Annalisa De Silvestri, Department of Clinic Epidemiology and Biometric, Scientific Direction, Fondazione IRCCS Policlinico San Matteo, Pavia 27100, Italy
Author contributions: Conti CB and Grassia R conceived and planned the study; Mainardi E, Grassia R, Drago A, Cereatti F, Soro S and Testa S carried out the tests and collected the data; Testa S and Mainardi E contributed to the interpretation of the results; De Silvestri A performed the statistical analysis; Conti CB wrote the manuscript; all authors provided critical feedback and helped the research and analysis of the manuscript.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board Comitato EticoVal Padana.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: No conflict of interest.
Data sharing statement: Technical appendix, statistical code, and data set available from the corresponding author at benedetta.conti1@gmail.com. Participants gave informed consent for data collection and data are recorded anonymized. Risk of identification is very low.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Clara Benedetta Conti, MD, Consultant Physician-Scientist, Department of Gastroenterology and Digestive Endoscopy, ASST Cremona, Viale Concordia 1, Cremona 26100, Italy. benedetta.conti1@gmail.com
Received: October 11, 2021
Peer-review started: October 11, 2021
First decision: December 3, 2021
Revised: December 14, 2021
Accepted: February 16, 2022
Article in press: February 16, 2022
Published online: March 16, 2022
Research background

Guidelines recommend to hold inflammatory bowel diseases (IBD) biologic therapy during coronavirus disease 2019 (COVID-19). It is still not clear if the IBD patients carry a high risk of developing severe COVID-19.

Research motivation

IBD patients could carry a high risk of relapse or worsening of the intestinal disease in holding the therapy.

Research objectives

To investigate the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies positivity and COVID-19 disease severity in IBD patients. Evaluate the correlation with clinical/therapeutic variables.

Research methods

Prospective cohort study. Patients with IBD were consecutively enrolled from April 22nd to May 31st 2020. Age, sex, BMI, IBD type, treatments and clinical activity and other comorbidities were anonymously collected in a Database. Charlson Comorbidity Index was calculated for each patient. A single blood test was performed to each patient to search for Immunoglobulin IgG anti SARS-Cov-2. The LIAISON® SARS-CoV-2 S1/S2 IgG test [DiasorinS.p.A, Saluggia (VC) – Italy] was used according to manufacturers’ instructions. The analysis was performed using SARS-CoV-2 IgG value cut off of > 7 kAU/L. All patients who resulted positive to SARS-CoV-2 IgG were tested with SARS-CoV-2 swab throat test during the same week, using the Allplex 2019-nCoV assay (Arrow Diagnostics S.r.l., Genova, Italy) a single-tube assay able to detect the three target genes (E gene, RdRP gene and N gene) as in the WHO recommended protocols. Categorical variables were described as count and percentage and compared between groups with chi square test; continuous variables were described as mean and standard deviation or median and inter-quartile range if not normally distributed (Shapiro-Wilks test) and compared with independent t- test or Mann-Whitney. Through univariate and multivariate logistic regression models were assessed: association between age, sex, BMI, IBD type, IBD treatments, IBD clinical activity, Charlson Comorbidity Index and SARS-CoV-2 IgG positivity or the presence of COVID-19 symptoms.

Research results

103 IBD consecutive patients were enrolled: 54 with Crohn’s disease and 49 ulcerative colitis. 36 patients (35%) were treated with biologic treatment, 14 (13.6%) with azathioprine (AZA) and 53 (51.4%) with mesalazine. 19 out of 103 patients (18.4%) had SARS-CoV-2 IgG positivity, with value > 7. Among them: 10 were under biological treatment, 5 under AZA and 4 under mesalazine. 12 out of 19 (63%) reported symptoms related to COVID-19 disease. Among them, 2 were treated with mesalazine, 4 with AZA and 6 with biologic treatment. Among the 7 out 19 patients without history of COVID-19 related symptoms, but positive for antibodies, 2 were treated with mesalazine, one with AZA and 4 with biologic therapy. All but one patient, who had pneumonia and was under AZA treatment, did not require hospitalization. All the patients with IgG > 7 were tested for swab throat test. All of them resulted negative at the enrollment. SARS-CoV-2 IgG value ≥ 7 correlated at multivariate analysis only with IBD treatment. The relative risk of having SARS-COV-2 IgG ≥ 7 was higher for patients treated with AZA and lower with mesalazine: odds ratio (OR) 1.44 (95%CI: 0.27-7.56) and 0.16 (95%CI: 0.03-0.71), for AZA and mesalazine, respectively, vs biologic drug (P = 0.0157 between them). The relative risk for patients under mesalazine was lower than for those under biologic therapy, P = 0.016. The presence of COVID-19 related symptoms resulted correlated at multivariate analysis with Body Mass Index (BMI), P = 0.05 and with IBD therapy. The relative risk of having symptoms was strongly higher for patients treated with AZA and lower with mesalazine vs biologic drug: odds ratio (OR) 7.47 (95%CI: 1.22-45.73) and 0.52 (95%CI: 0.17-1.72, P = 0.03), for AZA and mesalazine, respectively (P = 0.004 between them).

Research conclusions

The patients treated with biologic therapy don’t seem to carry a high risk of developing severe COVID-19.

Research perspectives

The patients treated with biologic therapy don’t seem to carry a high risk of developing severe COVID-19. Therefore, further and larger studies are needed to confirm these observations and to understand if the strategy to hold the IBD treatment during COVID-19 disease could be modified.