Does Biological Therapy Protect against Severe COVID-19?

  1. Ramon Mazzucchelli
  2. Raquel Almodovar González
  3. Natalia Crespi Villarías
  4. Elena García Zamora
  5. Elia Pérez Fernández
  6. Javier Quirós Donate
  7. Monserrat Pérez Encinas
  8. Patricia Sanmartín Fenollera
  9. María Velasco
  10. Pilar López Serrano
  11. Jose Lázaro Perez Calle
  12. Conrado Fernández Rodríguez
  13. José Luis López-Estebaranz
  14. Pedro Zarco

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Abstract

Objective

To estimate COVID-19 infection incidence rate with severe affectation (requiring hospitalization) in patients with biological treatment due to rheumatoid arthritis (RA), psoriatic arthritis (PsA), spondyloarthritis (SpA), psoriasis (Ps), and inflammatory bowel disease (IBD) and compare it with incidence rate in the general population.

Methods

Retrospective observational study based on information provided by two administrative databases. One of these two databases contains information on all patients seen in our hospital and diagnosed with COVID-19 infection between March 4th 2020 and April 26th 2020. The other database contains data from patients seen at Rheumatology, Dermatology and Digestive Departments in our hospital who are currently receiving biological therapy. We calculated the crude and age and sex adjusted incidence in both groups. To compare both groups we calculated the Incidence Rate Ratio.

Results

There was a total of 2,182 patients with COVID-19 requiring hospitalization. Four patients out of a total of 797 patients receiving biological therapy had contracted COVID-19 and required hospital care. Crude incidence rate of COVID-19 requiring hospital care among the general population was 1.41%, and it was 0.50% among the group receiving biological therapy. Rates adjusted by age and sex in the biological group was 0.45% (CI95% 0.11-4.13). The IRR of the group receiving biological therapy compared to the general population was 0.39 (CI95% 0.14-1, p=0.049).

Conclusion

Findings suggest that prior use of biological therapy does not associate with severe manifestations of COVID-19, and it is likely to have a protective effect against them when compared to the general population.

Key Messages

What is already known about this subject?

  • Covid-19 susceptibility in patients with immune-mediated disorders and receiving treatment with biological therapy is unknown.

What does this study add?

  • Severe manifestation incidence rate in patients with immune-mediated disorders receiving biological therapy treatment is not increased when compared to the general population.

  • Biological therapies might protect patients from presenting severe COVID-19 manifestations.

How might this impact on clinical practice?

  • These data could be used for current recommendations regarding management of patients receiving biological therapies.

Mini Abstract

The objective of this study is to analyze the incidence rate of severe COVID-19 requiring hospital care for patients receiving biological therapy and to compare it to the general population. Patients treated with biological therapy have crude and adjusted incidence rates under those of the general population.

Statement of Human and Animal Rights

This article does not contain any studies involving human participants or animals that were performed by the authors. For this type of study, formal consent was therefore not required.

Article activity feed

  1. ScreenIT

    SciScore for 10.1101/2020.06.21.20136788: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    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:
    As for this study, there are limitations. Only cases attended in the emergency service and requiring hospitalization have been identified, although there is knowledge of an unknown, but significant, number of rheumatic patients with mild COVID-19 whose detection was based on self-reports and phone consultations, but without PCR test confirmation. The real incidence of severe and non-severe cases among rheumatic patients, but also for the non-rheumatic population of reference, could only be reliably estimated with seroprevalence studies. One of the main limitations of this study is the low number of COVID-19 cases in the biological therapy cohort, which conditions the ability to analyze factors associated to developing a severe form of the disease. Taking all these limitations into consideration, definite conclusions cannot be drawn due to the limited number of cases. However, this study’s results suggest that patients with immune-mediated diseases and receiving biological therapy do not show higher risk for developing severe manifestations of COVID-19, and according to our data, it is very likely that this risk is lower than for the general population. In any case, it is necessary to confirm these results with a larger case series including a greater number of patients receiving biological therapy.

    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 10.1101/2020.06.21.20136788v1 on medRxiv