ABSTRACT
Objectives: To describe and compare real-world outcomes for patients with mild-to-moderate COVID-19 at high risk for progression to severe COVID-19, treated with sotrovimab versus untreated. Method(s): Electronic health records from the National COVID Cohort Collaborative were used to identify US patients (aged >=12 years) diagnosed with COVID-19 (positive test or ICD-10: U07.1) in an ambulatory setting (26 May 2021-30 April 2022) who met Emergency Use Authorization high-risk criteria. Patients receiving the monoclonal antibody (mAb) sotrovimab within 10 days of diagnosis were assigned to the sotrovimab cohort with an index date on the day of infusion. Untreated patients (no evidence of early mAb treatment or prophylaxis mAb or oral antiviral treatment) were assigned to the untreated cohort with an imputed index date based on the time distribution between diagnosis and sotrovimab infusion for the sotrovimab cohort. The primary endpoint was hospitalization or death (both all-cause) within 29 days of index, reported as descriptive rates and adjusted (via inverse-probability-of-treatment weighting [IPTW]) odds ratios (OR) and 95% confidence intervals (CI). Result(s): Of nearly 2.9 million patients diagnosed with COVID-19 during the analysis time period, 4,992 met the criteria for the sotrovimab cohort and 541,325 were included in the untreated cohort. Patients in the sotrovimab cohort were older (60 versus 54 years), more likely to be male (40% versus 38%) and White (85% versus 75%), and met more EUA criteria (3 versus 2) versus the untreated cohort. The 29-day hospitalization or mortality rates were 3.5% (176/4,992) and 4.5% (24,163/541,325) in the sotrovimab and untreated cohorts respectively (unadjusted OR [95% CI]: 0.77 [0.67,0.90];p=0.001;IPTW-adjusted OR [95% CI]: 0.74 [0.61,0.91];p=0.004). Conclusion(s): Sotrovimab demonstrated clinical effectiveness in preventing severe outcomes (hospitalization, mortality) between 26 May 2021-30 April 2022, which included the Delta variant and early surge of Omicron BA.1/BA.2. Funding(s): GSK (Study 219020)Copyright © 2023
ABSTRACT
Introduction: COPD patients are considered at risk of severe COVID-19 illness, however there are limited data on the burden of COVID-19 disease in this patient population. This study investigated the rate of COVID-19 diagnosis and hospitalization for COPD due to COVID-19 (pre-vaccination) over time, stratified by disease severity. Method(s): A retrospective cohort of COPD patients aged >=35 years, FEV1/FVC score <0.7, indexed from Mar-Aug 2020, using the English Clinical Practice Research Datalink Aurum database and Hospital Episode Statistics datasets. Monthly incidence rates of COVID-19 diagnosis and overall inpatient hospitalizations were described for all patients and by GOLD 2019 disease grade. Result(s): The study identified 103,105 COPD patients (mean [SD] age: 69.6 [10.6] years, 54.1% males) with 42.0%, 25.9%, 4.5%, and 6.3% in GOLD A, GOLD B, GOLD C, and GOLD D disease grade groups respectively, in the 12 months prior to index. Results over time are shown in Figure 1. Incidence rates of COVID-19 hospitalization (95% CI) per 100,000 person-days for the Mar-Aug period were GOLD A (2.2 [1.9, 2.6]), GOLD B (4.7 [4.1, 5.4]), GOLD C (4.6 [3.2, 6.3]), and GOLD D (7.9 [6.3, 9.7]). Conclusion(s): Among COPD patients, COVID-19 incidence peaked in April 2020. COVID-19 hospitalization rates were significantly higher in patients with more severe COPD and highest in GOLD D group patients. (Figure Presented).
ABSTRACT
S79 Figure 1ConclusionAmong patients with COPD in routine clinical practice in England, the frequency of moderate and severe exacerbations declined between January 2020 and April 2020 for most stratification groups and remained low through to August 2020. When comparing GOLD grade at baseline, the proportion of patients to experience an exacerbation increased with increasing disease severity grade.Please refer to page A211 for declarations of interest related to this abstract.
ABSTRACT
The objective was to evaluate real-world effectiveness of sotrovimab, a monoclonal antibody (mAb) for the treatment of high-risk outpatients with COVID-19, in reducing the risk of mortality or hospitalization during the SARS-CoV-2 Delta and initial Omicron variant waves in the US. A retrospective analysis was conducted of de-identified, high-risk patients diagnosed with COVID-19 (index date) from 1 September 2021 to 28 February 2022 in the FAIR Health FH NPIC claims database. Patients were divided into 2 cohorts based on claimed procedural codes: treated with sotrovimab and not treated with any mAb (no mAb). Facility-reported mortality ("mortality"), all cause hospitalizations and intensive care unit (ICU) admissions <=30 days of index were identified. Multivariable logistic regression was conducted to estimate the risk of 30-day mortality or hospitalization, adjusting for demographic and clinical factors. Of the high-risk COVID-19 patients identified,13,140 were treated with sotrovimab and 1,283,284 received no mAb therapy. In the no mAb cohort, 0.59% died and 5.74% were hospitalized (of whom 30% in ICU). In the sotrovimab cohort, 0.08% died and 2.50% were hospitalized (of whom 15% in ICU). After adjusting for potential confounders, sotrovimab treatment was associated with 85% reduced odds of 30-day mortality (OR: 0.15, 95% CI: 0.08-0.31) and 61% reduced odds of 30-day hospitalization or mortality (OR: 0.39, 95% CI: 0.35-0.44) among high-risk COVID-19 patients. In this US real-world study of high-risk COVID-19 patients during the Delta and initial Omicron waves, treatment with sotrovimab was associated with reduced odds of mortality and hospitalization compared to no mAb treatment.
ABSTRACT
Background. Sotrovimab, a monoclonal antibody (mAb), received Emergency Use Authorization (EUA) for the treatment of high-risk outpatients with symptomatic COVID-19. The study objective was to evaluate real-world effectiveness of sotrovimab (500 mg intravenous) in reducing the risk of mortality or hospitalization during the SARS-CoV-2 Delta and initial Omicron variant waves in the US. Methods. A retrospective analysis was conducted of de-identified patients (pts) diagnosed with COVID-19 (ICD-10: U07.1) from 9/1/2021 to 2/28/2022 in the FAIR Health FH NPIC claims database. Pts were divided into 2 cohorts based on HCPCS codes: treated with sotrovimab and not treated with any mAb (no mAb). Pts meeting EUA high-risk criteria were identified via pre-specified ICD-10-CM diagnoses in records <= 24 months prior to their first COVID-19 diagnosis (index date). Facility-reported mortality (referred to as 'mortality'), all cause hospitalizations and intensive care unit (ICU) admissions within 30 days of index were identified. Chi-square test, ANOVA, or t-tests were performed to statistically compare cohorts at a 0.05 level of significance (2-sided). P-values were not adjusted for multiplicity. Multivariable logistic regression was conducted to estimate the risk of mortality or hospitalization within 30 days, adjusting for demographic and clinical factors. Results. Of the high-risk COVID-19 pts identified, 13,140 were treated with sotrovimab and 1,283,284 received no mAb therapy. Compared to the no mAb cohort, the sotrovimab cohort was older, had more baseline conditions, and were more likely to be female (all p < 0.0001). In the no mAb cohort, 0.59% died and 5.74% were hospitalized (of whom 30% in ICU). In the sotrovimab cohort, 0.08% died and 2.50% were hospitalized (of whom 15% in ICU). After adjusting for potential confounders, treatment with sotrovimab was associated with 83% reduced odds of 30-day mortality (OR: 0.17, 95% CI: 0.09-0.31) and 61% reduced odds of 30-day hospitalization or mortality (OR: 0.39, 95% CI: 0.35-0.43) among high-risk COVID-19 pts. Conclusion. In this US real-world observational study of high-risk COVID-19 pts during the Delta and initial Omicron waves, treatment with sotrovimab was associated with reduced odds of mortality and hospitalization compared to no mAb treatment.
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S75 Figure 1ConclusionAmong patients with asthma, the frequency of severe exacerbations declined steeply between March 2020 and May 2020 for all stratification groups and remained low through to August 2020. When comparing GINA step at baseline, a higher proportion of patients in GINA steps 4 and step 5 experienced a severe exacerbation compared with patients in GINA steps 1/2, step 2 and step 3 throughout the observation period. Further research on the long-term impact of COVID-19 on asthma exacerbations in routine clinical practice in England is warranted.Please refer to page A211 for declarations of interest related to this .
ABSTRACT
S39 Figure 1ConclusionAmong patients with asthma, COVID-19 diagnosis rates peaked in April 2020, declined steeply to June 2020 and remained low through to August 2020. COVID-19 hospitalisation rates were substantially higher in patients with more severe asthma and highest among patients in GINA step 5 treatment group. Future studies on the long-term impact of COVID-19 in asthma are warranted.Please refer to page A209 for declarations of interest related to this .