Intensity and longevity of SARS-CoV-2 vaccination response in patients with immune-mediated inflammatory disease: a prospective cohort study

  1. David Simon
  2. Koray Tascilar
  3. Filippo Fagni
  4. Arnd Kleyer
  5. Gerhard Krönke
  6. Christine Meder
  7. Peter Dietrich
  8. Till Orlemann
  9. Johanna Mößner
  10. Jule Taubmann
  11. Melek Yalcin Mutlu
  12. Johannes Knitza
  13. Stephan Kemenes
  14. Anna-Maria Liphardt
  15. Verena Schönau
  16. Daniela Bohr
  17. Louis Schuster
  18. Fabian Hartmann
  19. Ioanna Minopoulou
  20. Moritz Leppkes
  21. Andreas Ramming
  22. Milena Pachowsky
  23. Florian Schuch
  24. Monika Ronneberger
  25. Stefan Kleinert
  26. Axel J Hueber
  27. Karin Manger
  28. Bernhard Manger
  29. Raja Atreya
  30. Carola Berking
  31. Michael Sticherling
  32. Markus F Neurath
  33. Georg Schett

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Abstract

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  1. Version published to 10.1016/s2665-9913(22)00191-6
  2. ScreenIT

    SciScore for 10.1101/2022.04.11.22273729: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study was approved by the Institutional Review Board of Erlangen University Hospital (
    Consent: #157_20 B), and written informed consent was obtained from all study participants.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Setting and Cohort: IMID patients and healthy controls (HC) were recruited from the prospective COVID-19 study program conducted by the Deutsche Zentrum fuer Immuntherapie, which since February 2020 has collected data on respiratory infections including COVID-19 as well as anti-SARS-CoV-2 antibody responses before and after the vaccination era and exposure risk behavior over time.
    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:
    Our study has some limitations. We have collected serum samples in an unscheduled timeline along the routine care of IMID patients, this may have resulted in more frequent or diligent sampling in IMID patients who get to visit the clinic more frequently. To mitigate this potential bias, we have used regression methods that account for within patient correlations using random effects. Samples from IMID patients were obtained predominantly under cytokine blocking treatments, therefore the overall between-group comparisons should reflect the weight of this treatment class, which affects the generalizability of our results. On the other hand, we also observe similar differences between IMID patients not receiving any immunomodulating treatment and HC. We did not attempt to separate the effects of treatments independent of diseases or antibody response across disease activity states, therefore the antibody levels reported here could be considered as average effects of treatments combined with the variety of diseases they are used for or similarly as average effects of diagnoses combined with their routine treatment patterns. We did not collect data on corticosteroid doses, however higher dosed corticosteroid treatments are usually given in combination with cytotoxic agents in conditions such as lupus nephritis or ANCA associated vasculitis. Therefore, their effects could be considered as embedded within those treatment categories and participants using only corticosteroid treatmen...

    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

    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.

  3. Version published to 10.1101/2022.04.11.22273729 on medRxiv