Serological Response to BNT162b2 and ChAdOx1 nCoV-19 Vaccines in Patients with Inflammatory Bowel Disease on Biologic Therapies

  1. Mohammad Shehab
  2. Fatema Alrashed
  3. Ahmad Alfadhli
  4. Khazna Alotaibi
  5. Abdullah Alsahli
  6. Hussain Mohammad
  7. Preethi Cherian
  8. Irina Al-Khairi
  9. Thangavel Alphonse Thanaraj
  10. Arshad Channanath
  11. Hamad Ali
  12. Mohamed Abu-Farha
  13. Jehad Abubaker
  14. Fahd Al-Mulla

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Abstract

Introduction: The immunogenicity of SARS-CoV-2 vaccines in patients with inflammatory bowel disease (IBD) on biologic therapies is not well studied. The goal of this study was to measure the serological response to BNT162b2 and ChAdOx1 nCoV-19 vaccines in patients with IBD receiving different biologic therapies. Methods: We performed a multi-center prospective study between 1 August 2021 and 15 September 2021. We measured the seropositivity of SARS-CoV-2 antibodies (SARS-CoV-2 IgG) and neutralizing antibody concentrations in patients with IBD receiving biologic therapies 4–10 weeks after their second dose or 3–6 weeks after their first dose of BNT162b2 or ChAdOx1 nCoV-19 vaccines. Results: A total of 126 patients were enrolled (mean age, 31 years; 60% male; 71% Crohn’s disease, 29% ulcerative colitis). Of these, 92 patients were vaccinated with the BNT162b2 vaccine (73%) and 34 patients with the ChAdOx1 nCoV-19 vaccine (27%). In patients being treated with infliximab and adalimumab, the proportion of patients who achieved positive anti-SARS-CoV-2 IgG antibody levels after receiving two doses of the vaccine were 44 out of 59 patients (74.5%) and 13 out of 16 patients (81.2%), respectively. In contrast, of those receiving ustekinumab and vedolizumab, the proportion of patients who achieved positive anti-SARS-CoV-2 IgG antibody levels after receiving two doses of the vaccine were 100% and 92.8%, respectively. In patients receiving infliximab and adalimumab, the proportion of patients who had positive anti-SARS-CoV-2 neutralizing antibody levels after two-dose vaccination was 40 out of 59 patients (67.7%) and 14 out 16 patients (87.5%), respectively. On the other hand, the proportion of patients who had positive anti-SARS-CoV-2 neutralizing antibody levels were 12 out of 13 patients (92.3%) and 13 out of 14 patients (92.8%) in patients receiving ustekinumab and vedolizumab, respectively. Conclusions: The majority of patients with IBD who were on infliximab, adalimumab, and vedolizumab seroconverted after two doses of SARS-CoV-2 vaccination. All patients on ustekinumab seroconverted after two doses of SARS-CoV-2 vaccine. The BNT162b2 and ChAdOx1 nCoV-19 SARS-CoV-2 vaccines are both likely to be effective after two doses in patients with IBD on biologics. Larger follow-up studies are needed to evaluate if decay of antibodies occurs over time.

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  1. Version published to 10.3390/vaccines9121471
  2. ScreenIT

    SciScore for 10.1101/2021.10.31.21265718: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: Ethical consideration and role of funders: This study was reviewed and approved by the Ethical Review Board of Mubarak Alkabeer Hospital and Dasman Center “Protocol # RA HM-2021-008” as per the updated guidelines of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013) and of the US Federal Policy for the Protection of Human Subjects.
    Consent: Subsequently, patient informed written consent was obtained before inclusion in the study.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    10 To evaluate the serological response to BNT162b2 or ChAdOx1 nCoV-19 vaccine in patients with IBD on biologic therapies, we measured levels of SARS-CoV-2 Immunoglobulin G (IgG) and neutralizing antibodies post vaccination.
    SARS-CoV-2 Immunoglobulin G (IgG
    suggested: None
    Laboratory Methods: In this study, anti-SARS-CoV-2 antibodies quantification from plasma to assess magnitude of systemic virus specific antibodies was performed using enzyme-linked immunosorbent assay (ELISA) kit (SERION ELISA agile SARS-CoV-2 IgG SERION Diagnostics, Würzburg, Germany) based on the manufacturer’s protocol.
    anti-SARS-CoV-2
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    However, our study has some limitations. It includes a small sample size of patients, so it was not powered to assess differences across medication subgroups. Furthermore, only humoral serological responses were assessed, it is likely that T cell-mediated immunity plays a possible protective role. Finally, given the observational nature of the study, possible confounders may exist, such as difference in biologic dosing and serum drug concentrations were not accounted for. A follow up larger studies needed to evaluate if decay of antibodies occurs over time and if a possible third booster vaccine dose may be needed. To conclude, this study showed that most patients with IBD on infliximab, adalimumab, and vedolizumab seroconverted after two doses of SARS-CoV-2 vaccination. All patients on ustekinumab seroconverted after two doses of SARS-CoV-2 vaccine. BNT162b2 and ChAdOx1 nCoV-19 SARS-CoV-2 are both likely to be effective after two doses in patients with IBD on biologics. A follow up larger studies are needed to evaluate if decay of antibodies occurs over time and if a third booster vaccine dose may be needed.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a protocol registration statement.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  3. Version published to 10.1101/2021.10.31.21265718v1 on medRxiv