Safety of administering biologics to IBD patients at an outpatient infusion center In New York City during the COVID-19 pandemic: Sars-CoV-2 seroprevalence and clinical and social characteristics

  1. Serre-Yu Wong
  2. Stephanie Gold
  3. Emma K. Accorsi
  4. Tori L. Cowger
  5. Dean Wiseman
  6. Reema Navalurkar
  7. Rebekah Dixon
  8. Drew S. Helmus
  9. CiTI Study Group
  10. Adolfo Firpo-Betancourt
  11. Damodara Rao Mendu
  12. Susan Zolla-Pazner
  13. Ken Cadwell
  14. Jean-Frederic Colombel

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Abstract

Patients with immune-mediated inflammatory diseases (IMIDs) and acquired and genetic immunodeficiencies receiving therapeutic infusions are considered high risk for SARS-CoV-2 infection. However, the seroprevalance in this group and the safety of routine administrations at outpatient infusion centers are unknown. To determine the infection rate and clinical-social factors related to SARS-CoV-2 in asymptomatic patients with IMIDs and immunodeficiencies receiving routine non-cancer therapeutic infusions, we conducted a seroprevalence study at our outpatient infusion center. We report the first prospective SARS-CoV-2 sero-surveillance of 444 IBD/IMID, immunodeficiency, and immune competent patients at an outpatient infusion center in the U.S. showing lower seroprevalence in patients compared with the general population and provide clinical and social characteristics associated with seroprevalence in this group. These data suggest that patients can safely continue infusions at outpatient centers.

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  1. ScreenIT

    SciScore for 10.1101/2021.03.15.21253615: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: 4,5 The Icahn School of Medicine at Mount Sinai Institutional Review Board approved the study.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    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:
    A limitation of the study is that it is from a single center. In conclusion, our data suggest patients can safely continue routine infusions at outpatient centers during the COVID-19 pandemic as the seroprevalence at our center was low; longitudinal follow-up of these patients would confirm this point. This information is useful to practitioners as many patients have opted to delay or discontinue infusions during the pandemic, risking disease flares and complications thereof, or switched to home infusions, which has been associated with adverse outcomes.2,3 This is all the more important in our urban cohort given the disparity of seroprevalence by socio-economic factors. Finally, the functionality and durability of immune responses to SARS-CoV-2 infection, as well as COVID-19 vaccines, remain to be determined in IBD patients, who were not included in COVID-19 vaccine trials.

    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.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.03.15.21253615v1 on medRxiv