Omalizumab administration for refractory to H1-antihistamines chronic urticaria has a protective effect against symptomatic COVID-19 infection: Results from the GREEk National Urticaria Registry (GREENUR)

ABSTRACT

Background: There is no evidence clearly defining whether the administration of immunomodulatory biologic agents to allergic patients affects their immune response to COVID-19 infection. The current guidelines suggest the continuation of their use in patients who are not infected, while the continuation is individualized in the case of symptomatic disease. We sought to determine the cumulative incidence of symptomatic COVID-19 infection among chronic urticaria (CU) Greek patients, who, until 2/2/2021, were under omalizumab for at least two months. This was the date on which no Greek citizen was considered fully immunized due to vaccination against SARS-CoV- 2. Method(s) The present study extracted data from the first national multicenter registry of patients in Greece with chronic urticaria (GREEk National Urticaria Registry, GREENUR). All patients with CU under omalizumab during the pandemic, and the clinical characteristics of those with COVID-19 symptomatic infection, were recorded. Result(s) 329 patients were included (223 with CSU alone). Only 10/329 (6 women) or 3% had symptomatic COVID-19 infection confirmed by Polymerase Chain Reaction (PCR) analysis. Overall, 6 patients reported fever (up to 39.5degreeC), 5 rhinitis, 3 cough, one of which reported shortness of breath controlled with bronchodilation, 5 hyposmia/anosmia and ageusia, 8 muscle weakness, 5 arthralgia/ myalgia, and 7 headache. None of the patients was admitted to the hospital. According to the Centers for Disease Control and Prevention (CDC), only 1 in 4.2 cases of COVID-19 is being examined, of which 84% are symptomatic. Consequently, the cumulative incidence of symptomatic COVID-19 infection in the general Greek population on 2/2/2021 (number of confirmed cases on that date 158,716) was estimated at 5.2%, significantly higher than that among patients with CU (p-value = 0.02). Conclusion(s) The cumulative incidence of symptomatic COVID-19 infection among patients with CU under omalizumab treatment is lower than that of the general population. All infected patients had a mild course and short duration of the disease and did not need hospitalization. These findings demonstrate not only the safety but also a protective role of omalizumab in patients with CU during the COVID-19 pandemic.