ABSTRACT
Background: The use of biologics during the pandemic has raised concerns throughout the scientific community. The current guidelines suggest continuing the use of biologics during the pandemic, while the initiation or continuation of treatment in case of symptomatic disease are remaining controversial unanswered questions. As a result the purpose of this study was to determine the frequency of symptomatic COVID19 infection in patients treated with biologic agents in an Allergy Unit of a University Hospital during the pandemic. Method(s): Patients of the Allergy Unit "D Kalogeromitros", who due to asthma, atopic dermatitis, Chronic Spontaneous Urticaria(CSU) or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)were under treatment with biologic agents were included in the present study. Treatment of at least 2 months until the 31/12/2021 was necessary for a patient to be included in the present study. Result(s): A total of 77 patients [46 (59.7%) women, mean age 48.2 (range 15-82) years were included. The mean duration of treatment with biologics was 34.9 months (SD: +/-37 months). Overall, 83.1% (64/77) of patients were receiving omalizumab for asthma and CSU [13/64 (20.3%) and 51/64 (79.6%) respectively] while 9.1% (7/77) were receiving dupilumab for atopic dermatitis (4/7) and CRSwNP [4/7 (57.1%) and 3/7 (42.8%) respectively]. In addition, 5/77 (6.5%) and 1/77 (1.2%) were under treatment with mepolizumab and one with benralizumab respectively, due to severe uncontrolled asthma. A total of 6 patients with chronic spontaneous urticaria and 2/19 patients with asthma (1/5 with mepolizumab and 1/13 with omalizumab) had symptomatic COVID 19 infection as confirmed with a positive Polymerase Chain Reaction or Rapid Test. None of the patients treated with benralizumab or dupilumab had symptomatic COVID19 infection. Overall, 8/77 (10.3%) of patients had symptomatic SARS-CoV2 infection during the above period, a rate similar to the onein the same period identified in the general Greek population (11.2%). All patients had mild symptoms during the disease course with no patient admission to hospital. Conclusion(s): The frequency of symptomatic COVID19 infection identified in a population of Greek patients treated with biologic agents was no higher than than the one in the general Greek population. Furthermore, all patients had a mild course of the disease with no admissions, indicating that the use of biologics is a safe choice and can be continued during the pandemic.
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.
ABSTRACT
Background: With the launch of COVID-19 vaccination, cases of allergic reactions to tozinameran were soon reported, with excipient polyethylene glycol (PEG) 2000 becoming the principal suspect. We present the immediate reactions recorded in our Vaccination Center, the allergological workup performed and the outcome of the second dose whenever administered. Method: This is a prospective study among people working in public health care facilities and armed and security forces who received the first dose between 27/12/2020 and 17/01/2021. Reactions with at least one objective sign observed within 6 hours after vaccination were recorded. Allergological investigation was carried out 14-20 days later as follows: 1/ skin prick tests to tozinameran 100%, PEG 6000 (100mg/ml) 10% and 100%, polysorbate 80 (50mg/ml) 10% and 100%, intradermal tests with PEG 6000 up to 1% and polysorbate 80 up to 0.1% both in three consecutive 10-fold dilutions, 2/ serum tryptase (reaction's and basal), 3/ basophil activation test (BAT) to PEG 2000. The same work-up was followed for patients who had received their shot in other vaccination centers but were referred for investigation. Results: From a total of 1755 immunizations, 14 reactions (0.8%) were recorded in our unit and extra 8 referred reactions were included in the work-up. Median age was 43.5 years (range 28-59) and 72.7% were female. Mean time of onset was 14 min (range 3-40) with a broad duration frame (1-72h). Hypertension and tachycardia were the most prevalent symptoms (86.4% and 77.3% respectively);flushing (63.6%), nausea/eructation or intestinal hyperperistalsis (36.4%), tremor (22.7%) were also recorded. Reaction's serum tryptase was measured in 8/20 patients;elevated compared to baseline was detected only in a 32ys old female treated with IM adrenaline. Skin tests were performed in 17/22 patients, none turned positive. BAT results were positive in 1/5 reactors. Finally, 13/22 already received the second dose, with 10/13 (77%) not reacting at all, while the rest experienced a much milder similar reaction. Conclusion: Female predominated and a special pattern of reaction with elevated blood pressure/ heart rate along with flushing and/ or increase in gastrointestinal motility, resembling the acute stress response (“fight-or-flight”) was observed. PEG does not seem to be the offending “allergic” agent. Polysorbate 80 can be tested before administration of other SARS-CoV-2 vaccine in case of suspended PEG allergy. (Table Presented).