Background: In a phase III clinical trial, casirivimab and imdevimab (CAS+IMD) reduced the composite risk of COVID-19-related hospitalizations or all-cause mortality in outpatients at risk of severe disease. This study assessed the real-world effectiveness of CAS+IMD. Methods: Data from Optum Clinformatics Data Mart (CDM) and IQVIA Pharmetrics Plus (PMTX+) were used to identify patients diagnosed with COVID-19 in ambulatory settings between December 2020 and March 2021 (PMTX+) and June 2021 (CDM), and either treated with CAS+IMD or untreated but treatment-eligible under Emergency Use Authorization. CAS+IMD-treated patients were matched to untreated patients and followed up to 30 days for the composite of all-cause mortality or COVID-19-related hospitalizations (CDM) and COVID-19-related hospitalizations (PMTX+). Kaplan-Meier estimators were used to calculate outcome risks; Cox proportional-hazard models provided adjusted hazard ratios (aHR) with 95% confidence intervals (CI). Results: For CDM, 1116 CAS+IMD-treated patients were matched to 5294 untreated patients; for PMTX+, 3280 CAS+IMD-treated patients were matched to 16 284 untreated patients. The 30-day composite risk was 2.1% and 5.3% in the treated and untreated cohorts, respectively (CDM), and the 30-day risk of COVID-19-related hospitalization was 1.9% and 4.8%, respectively (PMTX+), translating to a 61% lower risk of hospitalization or mortality with CAS+IMD: CDM aHR 0.39 (95% CI 0.26-0.60), PMTX+ aHR 0.39 (95% CI 0.30-0.51). The benefit of treatment was maintained across subgroups, and earlier intervention was associated with improved outcomes. Conclusions: Results of this real-world study further support randomized clinical trial findings that treatment with CAS+IMD reduces the risk of hospitalization and mortality.

Background Sarcopenia is defined as age-related low muscle mass and function, and can also describe the loss of muscle mass in certain medical conditions, such as sarcopenic obesity. Sarcopenic obesity describes loss of muscle and function in obese individuals; however, as sarcopenia is an age-related condition and obesity can occur in any age group, a more accurate term is obesity with low lean muscle mass (OLLMM). Given limited data on OLLMM (particularly in those aged < 65 years), the purpose of this study was to estimate the prevalence of OLLMM in adults aged ≥ 20 years in the USA. Methods Data from the National Health and Nutrition Examination Survey (NHANES) 2017–2018 and 1999–2006 were used. OLLMM was defined as an appendicular lean mass, adjusted for body mass index (BMI), cut-off point < 0.789 for males and < 0.512 for females, measured by dual-energy X-ray absorptiometry (DXA). DXA was only measured in individuals 20–59 years old in NHANES 2017–2018; we therefore utilized logistic regression models to predict OLLMM from NHANES 1999–2006 for those aged ≥ 60 years. The prevalence of OLLMM was estimated overall, and by sex, age, race/ethnicity, and clinical subgroup (high BMI, prediabetes, type 2 diabetes mellitus [T2DM], non-alcoholic fatty liver disease [NAFLD] with fibrosis, or post-bariatric surgery). Prevalence estimates were extrapolated to the USA population using NHANES sampling weights. Results We estimated that, during 2017–2018, 28.7 million or 15.9% of the USA population had OLLMM. The prevalence of OLLMM was greater in older individuals (8.1%, aged 20–59 years vs 28.3%, aged ≥ 60 years), highest (66.6%) in Mexican-American females aged ≥ 60 years, and lowest (2.6%) in non-Hispanic Black males aged 20–59 years. There was a higher prevalence of OLLMM in adults with prediabetes (19.7%), T2DM (34.5%), NAFLD with fibrosis (25.4%), or post-bariatric surgery (21.8%), compared with those without each condition. Conclusions Overall, the burden of OLLMM in the USA is substantial, affecting almost 30 million adults. The prevalence of OLLMM increased with age, and among those with prediabetes, T2DM, NAFLD with fibrosis, or post-bariatric surgery. A unified definition of OLLMM will aid diagnosis and treatment strategies.

ImportanceData on real-world effectiveness of casirivimab and imdevimab (CAS+IMD) for treatment of coronavirus 2019 (COVID-19) are limited, especially with regard to variants of concern such as Delta.ObjectiveTo assess effectiveness of CAS+IMD versus no COVID-19 antibody treatment among patients diagnosed with COVID-19 in the ambulatory setting overall and among subgroups, including patients diagnosed during the Delta-dominant period prior to Omicron emergence.DesignRetrospective cohort study.SettingKomodo Health closed claims database.ParticipantsPatients diagnosed with COVID-19 in ambulatory settings from December 2020 through September 2021 treated with CAS+IMD or untreated but treatment-eligible under the Emergency Use Authorization (EUA). Each treated patient was exact- and propensity score-matched without replacement to up to 5 untreated EUA-eligible patients.ExposureCAS+IMD treatment.Main Outcomes and MeasuresComposite endpoint of 30-day all-cause mortality or COVID-19-related hospitalization. Kaplan-Meier estimators were used to calculate risk of outcome overall and across subgroups defined by age groups, COVID-19 vaccination status, immunocompromised, and timing of COVID-19 diagnosis (December 2020 to June 2021, and July 2021 to September 2021). Cox proportional-hazards models were used to estimate adjusted hazard ratios (aHR) and 95% confidence intervals (95% CI).ResultsAmong 75 159 patients treated with CAS+IMD and 1 670 338 EUA-eligible untreated patients, 73 759 treated patients were matched to 310 688 untreated patients; matched patients had an average age ∼50 years, approximately 60% were women and were generally well-balanced across risk factors. The 30-day risk of the composite outcome was 2.1% and 5.2% in the CAS+IMD -treated and untreated patients, respectively; CAS+IMD treatment was associated with a 60% lower risk of the outcome (aHR 0.40; 95% CI, 0.38-0.42). The effect of CAS+IMD treatment was consistent across subgroups, including those who received a COVID-19 vaccine (aHR 0.48, 95% CI, 0.41-0.56), and those diagnosed during the Delta-dominant period (aHR 0.40, 95% CI, 0.38-0.42).Conclusions and RelevanceThe real-world effectiveness of CAS+IMD is consistent with the efficacy for reducing all-cause mortality or COVID-19-related hospitalization reported in clinical trials. Effectiveness is maintained across patient subgroups, including those who may be prone to breakthrough infections, and was effective against susceptible variants including Delta.□

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Introduction Data on real-world effectiveness of subcutaneous (SC) casirivimab and imdevimab (CAS+IMD) for the treatment of coronavirus disease 2019 (COVID-19) are limited. The objective of this study was to assess the effectiveness of SC CAS+IMD versus no antibody treatment among patients with COVID-19. Methods This retrospective cohort study linked Komodo Health and CDR Maguire Health and Medical data. Patients diagnosed with COVID-19 in ambulatory settings (August 1–October 30, 2021) treated with SC CAS+IMD were exact- and propensity score-matched to fewer than five untreated treatment-eligible patients and followed for the composite endpoint of 30-day all-cause mortality or COVID-19-related hospitalization. Kaplan–Meier estimators were used to calculate outcome risk overall and across subgroups. Cox proportional-hazards models were used to estimate adjusted hazard ratios (aHR) and 95% confidence intervals (CI). Results Of 13,522 patients treated with CAS+IMD, 12,972 were matched to 41,848 untreated patients. The 30-day composite outcome risk was 1.9% (95% CI 1.7–2.2) and 4.4% (95% CI 4.2–4.6) in the treated and untreated cohorts, respectively; treated patients had a 49% lower relative risk of the composite outcome (aHR 0.51; 95% CI 0.46–0.58) and a 67% relative risk of 30-day mortality (aHR 0.33, 95% CI 0.18–0.60). Effectiveness was consistent across vaccination status and various subgroups. Discussion Patients with COVID-19 benefitted from treatment with SC CAS+IMD versus untreated patients. The results were consistent across subgroups of patients, including older adults, immunocompromised patients, and patients vaccinated against COVID-19. Results were robust across numerous sensitivity analyses. Conclusion SC CAS+IMD is effective in reducing 30-day COVID-19-related hospitalization or mortality in real-world outpatient settings during the Delta-dominant period. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-022-00691-z.