A prospective study into COVID-19 like symptoms in patients with and without immune mediated inflammatory diseases or immunomodulating drugs

Van Ouwerkerk, L.; Van Der Meulen, A.; Ninaber, M.; Teng, Y. K. O.; Huizinga, T.; Allaart, C.

Background: Patients with an immune mediated inflammatory disorder or post solid organ transplantation (IMIDT), are at risk for infectious complications especially if they are treated with immunosuppressive drugs (imeds). There is still great uncertainty whether these IMIDT patients are more susceptible to COVID-19 than controls, and/or should be advised to avoid taking their immunosuppressive treatment. Objectives: To evaluate whether patients with IMIDT are more at risk for CLS than controls. Methods: The IENIMINI study is a prospective cohort study in patients with IMIDT and controls (healthy or no IMIDT) who were identified based on the registration database of the Leiden University Medical Center. Over time, participants registered COVID-like symptoms (CLS) as they occurred, and filled in additional questionnaires. Univariate and multivariate regression analyses were done to identify variables associated with having CLS. Results: Of the 8670 individuals approached, 2110 with IMIDT and 1067 controls agreed to participate. In March and April, 454 (22%) of IMIDT patients and 242 (23%) of controls recorded to have CLS, mostly mild with a median (IQR) duration of seven (3-14) days in the IMIDT group and six days (4-11) in the control group. Eleven (5%) of the IMIDT patients with immunosuppressive medication (imed), 6 (3%) of IMIDTs without imed and 2 (1%) of controls were hospitalized with CLS (p=0.04). In May and June, fewer episodes overall were recorded. Being female (OR 1.45 95%CI 1.15;1.82), having a lung disease (OR 1.50 95%CI 1.20;1.88) and wearing a face mask (OR 1.42 95%CI 1.13-1.77) were independently associated with a higher risk, while higher age (OR 0.96 95%CI 0.96;0.97) and having an IMIDT with immunosuppressive medication use (OR 0.68 95%CI 0.51;0.91) were independently associated with a lower risk (see Table 1). Similar results were found after data imputation. Conclusion: Between March and July 2020, IMIDT patients, whether or not taking imeds, did not show an increased risk of reported COVID-like symptoms compared to controls. Continuing immunosuppressant drugs as long as not ill, while following the Dutch COVID rules, appears to be safe.