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COVID-19 and biologics in severe asthma: data from the Belgian Severe Asthma Registry


Epidemiologic studies suggest that patients with asthma are not at an increased risk of severe COVID-19 caused by the novel coronavirus SARS-CoV-2. Recent studies indicate that the severity of COVID-19 in patients with asthma is likely to depend on multiple factors. A type 2-low asthma phenotype, use of oral corticosteroids and severe asthma could be aggravating factors, while maintenance treatment with inhaled corticosteroids (ICS) and good asthma control are probably protective. However, there is currently scarce information on the risk associated with COVID-19 in subjects with severe asthma and/or the use of biologics. Since eosinopenia is a biomarker for the severity of COVID-19, the eosinophil depletion induced by anti-interleukin-5 (IL5) and anti-IL5 receptor blocking monoclonal antibodies raises concern in patients and their treating physicians. The handful of case reports about patients using the monoclonal antibodies omalizumab, benralizumab or dupilumab for atopic dermatitis do offer a reassuring picture, but larger studies performed in patients with asthma are urgently needed. In immune-mediated inflammatory diseases, such as rheumatoid arthritis and psoriasis, treatment with biologics was not associated with worse COVID-19 outcomes. Most respiratory societies and guidelines recommend to continue asthma patients on their regular treatments, including asthma biologics for those who qualify for them, but epidemiologic or clinical research data are lacking.

The aim of our observational study was to evaluate the occurrence of COVID-19 in adult patients with severe asthma, based on data from the Belgian Severe Asthma Registry (BSAR), and to assess whether patients with severe asthma using biologics present an increased risk of severe COVID-19 as compared to those who do not use these medications.

The BSAR, a prospective cohort of patients with severe asthma defined according to the ERS/ATS criteria, has been enrolling patients since 2009. After obtaining the approval for an amendment from the BSAR's central ethics committee (UZ Gent; B67020084584), 9 participating asthma centres contacted their patients. Of the 777 severe asthmatics that were contacted, 676 (87%) participated in this survey.

A standardised questionnaire was administered by phone or during outpatient visits and inquired about symptoms suggestive of COVID-19, hospital admission for COVID-19 and diagnostic testing through nasopharyngeal swab (PCR) or serology (SARS-CoV2 IgG). Patients were contacted between April 30th and July 8th. Until April 24th, the government policy in Belgium was to limit PCR testing to healthcare workers or severe COVID-19 cases requiring hospitalisation. In case of milder symptoms, patients were put in quarantine but were not tested. After April 24th, a greater proportion of samples were collected from symptomatic and asymptomatic people, as part of screening procedures, for instance prior to an intervention or hospitalisation. The monoclonal antibodies available for clinical use in severe asthma in Belgium are omalizumab, mepolizumab, benralizumab and reslizumab, while dupilumab is not yet reimbursed for asthma.

Two hundred sixty-six (39%) of the 676 participants had experienced at least 1 symptom suggestive of COVID-19 during the 4 months preceding the survey. Dyspnea (n=172; 25%), rhinorrhea (n=116; 17%), productive cough (n=107; 16%), headache (n=105; 16%) and chest pain (n=69; 10%), were the most frequently reported symptoms. Only 35 (5%) of the patients experienced sudden olfactory and gustative dysfunction, symptoms that are considered quite specific for COVID-19, suggesting a low incidence of symptomatic COVID-19 in the study population.

Out of 676 patients, only 66 were tested by PCR on nasopharyngeal aspirates and 9 tested positive for SARS-CoV-2. As the national restrictions with regard to PCR-testing might have led to an underestimation of the true incidence of SARS-CoV2 infection in severe asthmatics in Belgium, we also performed serology testing with measurement of SARS-CoV2-IgG antibodies in a subgroup of patients that had presented symptoms suggestive of COVID-19. Positive IgG serology was found in only 8 out of 98 tested patients. Of note, 3 of these patients who showed positive SARS-CoV2-IgG also demonstrated a positive PCR test. Overall, we identified 14 patients with COVID-19 infection confirmed by either PCR and/or specific IgG. Of these 14 patients, only 5 (all PCR-positive) had been hospitalised (with a short hospital stay ranging from 2 to 8 days). None presented with a severe asthma exacerbation or required treatment with systemic corticosteroids, admission to the intensive care unit, non-invasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation (ECMO), and there were no deaths. Only 3 patients received supplemental oxygen therapy (for 3 to 8 days). Chest CT-scan was performed in 4 hospitalised severe asthma patients and revealed pulmonary infiltrates in 3 patients. Patients with confirmed COVID-19 reported a significantly higher median number of symptoms than the rest of the study population [6 (IQR 3–10) versus 2 (IQR 1–3), p<0.000001]. Importantly, there was no difference in incidence of COVID-19 between severe asthma patients treated with biologics (anti-IgE or anti-IL5/anti-IL5R) and patients not receiving any asthma biologic (p>0.05).

To the best of our knowledge, this study is the first to investigate the risk and severity of COVID-19 in a large cohort of well-characterized patients with severe asthma. The findings indicated a low incidence of COVID-19 infection in severe asthmatics (14 out of 676 patients; 2.1%). Nevertheless, it is difficult to compare the incidence rate of confirmed COVID-19 cases in our BSAR cohort to the figure in the general population. Analysis of blood samples from Belgian blood donors revealed a seroprevalence reaching up to 5.1%. Our study showed that only 2.1% of severe asthmatics in Belgium had positive PCR or specific IgG to SARS-CoV-2 and that only 5% presented COVID-19-related symptoms. Whether this relatively low incidence is due to severe asthmatics being more cautious than the general population and complying better with social distancing and other hygienic measures, or whether it is due to (patho)physiological features (type 2 inflammation) or beneficial effects of treatments such as ICS (the latter factors being associated with lower ACE2 expression) remains to be elucidated.

In conclusion, no deaths or cases of very severe COVID-19 were identified among this cohort of adult patients with severe asthma. Treatment with biologics for severe allergic or severe eosinophilic asthma was not associated with a higher risk of SARS-CoV-2 infection nor with more severe COVID-19. These data support the current practice to continue treatment with biologics in severe asthma during the COVID-19 pandemic.

Footnotes

  • Author contributions: S.H., G.B. and F.S. conceived the study. D.S. and all co-authors collected the data. S.H. and F.S. analysed the data, and co-wrote the manuscript. All authors provided critical feed-back on the data, edited the manuscript and guarantee the accuracy of the data and the ensuing manuscript.

  • Conflict of interest: Dr. Hanon reports personal fees from GSK, personal fees from AstraZeneca, personal fees from Teva, personal fees from Sanofi, personal fees from Novartis, grants and personal fees from Chiesi, outside the submitted work.

  • Conflict of interest: Dr. Brusselle reports personal fees from AstraZeneca, personal fees from Boehringer-Ingelheim, personal fees from Chiesi, personal fees from GSK, personal fees from Novartis, personal fees from Sanofi, personal fees from Teva, outside the submitted work.

  • Conflict of interest: Dr Deschampheleire has nothing to disclose

  • Conflict of interest: Dr. LOUIS reports grants and personal fees from GSK, grants and personal fees from Astra Zeneca, grants and personal fees from Novartis, grants from Chiesi, outside the submitted work.

  • Conflict of interest: Dr. Michils reports grants, personal fees and non-financial support from AstraZeneca, grants, personal fees and non-financial support from Chiesi, grants and personal fees from Glaxosmithkline, personal fees from Novartis, outside the submitted work.

  • Conflict of interest: Dr. PECHE has nothing to disclose.

  • Conflict of interest: Dr. Pilette has nothing to disclose.

  • Conflict of interest: Dr. Rummens has nothing to disclose.

  • Conflict of interest: Dr. Schuermans has nothing to disclose.

  • Conflict of interest: Dr Hélène SIMONIS has nothing to disclose

  • Conflict of interest: Dr. Vandenplas has nothing to disclose.

  • Conflict of interest: Dr. Florence has nothing to disclose.

  • Received July 21, 2020.
  • Accepted September 27, 2020.

sumber : https://erj.ersjournals.com/content/early/2020/10/02/13993003.02857-2020?utm_source=TrendMD&utm_medium=cpc&utm_campaign=European_Respiratory_Journal_TrendMD_0

 
 

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