Higher Rates of COVID-19 but Less Severe Infections Reported for Patients on Il-4/Il-13 Blocker: A Big Data Analysis of the WHO Vigibase

Abstract

Background: Dupilumab (Dupixent®) is a monoclonal antibody that inhibits IL-4 and IL-13 signaling used for the treatment of allergic diseases. Whilst biological therapy is generally associated with an increased risk of infectious disease, prior studies have suggested Dupilumab may be protective. Objective: We investigated the link between Dupilumab therapy and SARS-CoV-2 infection.Methods: We carryied out a comprehensive data-mining and disproportionality analysis of the WHO global pharmacovigilance database. One asymptomatic COVID-19 case, 106 cases of symptomatic COVID-19, and 2 cases of severe COVID-19 pneumonia were found. Results: Dupilumab treated patients were at higher risk of COVID-19 (with an IC0.25 of 3.05), even though infections were less severe (IC0.25 of -1.71). The risk of developing COVID-19 was significant both among males and females (with an IC0.25 of 0.24 and 0.58, respectively). The risk of developing COVID-19 was significant in the age-group of 45-64 years (with an IC0.25 of 0.17). Limitations: Limitations include: the heterogeneous nature of the database sources. Furthermore, a direct causal relationship cannot be inferred from the current investigation.Conclusion: Dupilumab use was found to reduce COVID-19 related severity. Further studies are needed to better understand the immunological mechanisms and clinical implications of these findings.