Abstract

Importance: Since the beginning of the Coronavirus Disease-19 (COVID-19) pandemic, Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection has been a serious challenge for immune-compromised patients with immune-mediated inflammatory diseases (IMIDs). Objective: Our aim was to investigate the impact of COVID-19 in terms of risks of infection, hospitalization and mortality in a cohort of patients with rheumatoid arthritis (RA), psoriasis (PSO) or inflammatory bowel disease (IBD). Furthermore, we studied the impact of SARS-CoV-2 infection on the prescribed drug regimen in these patients. Methods: Through the record linkage between health information systems, a cohort of patients, ≥18 years old, assisted in the Lazio region and who had suffered from immune-mediated inflammatory diseases (RA, PSO, IBD) between 2007 and 2019, was identified. The risk of infection, hospitalization or mortality for COVID-19, was assessed by logistic regression models, and reported in an Odds Ratio (ORs; CI 95%), adjusting for sex, age and the Charlson Comorbidity Index. We also estimated these risks separately by IMID and in the subgroup of prevalent biologic drug users. We investigated deferral of biological treatments in the study population by comparing the prevalence of weekly use of biologicals (2019–2020) before and during the pandemic periods. Findings: Within the 65,230 patients with IMIDs, the cumulative incidence for COVID-19 was 303/10,000 ab. In this cohort of patients, we observed a significantly higher risk of SARS-CoV-2 infection than the general population: OR = 1.17 (95% CI 1.12–1.22). The risk was higher even considering separately each disease and in the subgroup of prevalent biologic drug users. This last subgroup of patients showed a higher risk of death related to COVID-19 (OR 1.89; 95% CI 1.04–3.33) than the general population. However, no differences in terms of risks of hospitalization or death related to COVID-19 were recorded in patients with the IMIDs. Comparing the 2019–2020 prevalence of weekly biological drug treatments in prevalent biologic drug users, we found a decrease (−19.6%) during the lockdown, probably due to pandemic restrictions. Conclusions and Relevance: Patients with IMIDs seem to have a higher risk of SARS-CoV2 infection. However, other than for patients with prevalent biologic drug treatment, no significant differences in terms of hospitalization and mortality were reported compared to the general populations; further investigation is warranted on account of unmeasured confounding. In addition, during the lockdown period, the COVID-19 emergency highlighted a lower use of biologic drugs; this phenomenon requires strict pharmacological monitoring as it could be a proxy of forthcoming long-term clinical progression.

Highlights

  • The coronavirus disease-19 (COVID-19) pandemic raises relevant concerns in patients with immune-mediated inflammatory diseases (IMIDs), in particular if they belong to a vulnerable population at an increased risk of COVID-19 prevalence and complications as a consequence of the intrinsic immune system dysregulation and the use of immunosuppressive therapy [1]

  • In our cohort, which included 65,230 patients with IMIDs, we showed that these patients have a higher prevalence of SARS-CoV-2 infection (303/10,000 inhabitants), than the general population

  • Their clinical outcomes were not significantly different from that reported in the general population, with the exception of the subgroup of patients with prevalent biologic drug treatments in which a higher risk of mortality related to COVID-19 was detected

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Summary

Introduction

The coronavirus disease-19 (COVID-19) pandemic raises relevant concerns in patients with immune-mediated inflammatory diseases (IMIDs), in particular if they belong to a vulnerable population at an increased risk of COVID-19 prevalence and complications as a consequence of the intrinsic immune system dysregulation and the use of immunosuppressive therapy [1]. The management of IMID patients during the COVID-19 pandemic has become significantly more complex for other reasons such as the limited access to primary care or the contradictory messages on the protective/causative role of the immunosuppressor for SARS-CoV-2, which can fuel psychological distress and lead to a reduction in compliance and adherence to the immune-suppressor therapy [7] For these reasons, we aim to study the risks of infections, hospitalizations, or mortality related to COVID-19 in a cohort of patients with rheumatoid arthritis (RA), psoriasis (PSO), or inflammatory bowel diseases (IBD). We want to study the prevalence of drug treatments with biologic therapies before and after the lockdown due to the pandemic period and in particular during the pandemic restrictions

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