Effectiveness of Subcutaneous Casirivimab and Imdevimab in Ambulatory Patients with COVID-19

Abstract

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.

Outpatient anti-spike monoclonal antibody administration is associated with decreased morbidity and mortality among patients with cancer and COVID-19

“…To our knowledge, such a mortality benefit from mAbs, compared to untreated patients, has not been previously shown in a cohort of patients with solid tumors and HM. Our findings agree with several other multicenter observational series of immunocompromised patients with mild or moderate COVID-19, who were given mAbs in the outpatient setting, which demonstrated lower than expected hospitalization and mortality rates [ 9 , 23 , 25 ]. Similarly, our results agree with the findings of a Czech multicenter study that included only patients with HM who received bamlanivimab or casirivimab/imdevimab [ 26 ].…”

“…Similarly, Ganesh et al, in a study of more than 3,500 patients who received bamlanivimab or casirivimab/imdevimab, referred broadly to immunocompromised status, which is one of the inclusion criteria under the EUA [ 8 ]. In a retrospective cohort study by Jalbert et al [ 9 ] that included more than 13,000 patients who received casirivimab/imdevimab, patients with cancer or chemotherapy were included as a separate category for cohort-matching purposes, but their malignancy characteristics were not described, nor the direct effect of mAbs on this subpopulation. And in the COMET-ICE randomized clinical trial for sotrovimab, patients with cancer receiving immunosuppressive chemotherapy or immunotherapy were explicitly excluded [ 7 ].…”

Outpatient anti-spike monoclonal antibody administration is associated with decreased morbidity and mortality among patients with cancer and COVID-19

“…To our knowledge, such a mortality bene t from mAbs, compared to untreated patients, has not been previously shown in a cohort of patients with solid tumors and HM. Our ndings agree with several other multicenter observational series of immunocompromised patients with mild or moderate COVID-19, who were given mAbs in the outpatient setting, which demonstrated lower than expected hospitalization and mortality rates 9,22,24 . Similarly, our results agree with the ndings of a Czech multicenter study that included only patients with HM who received bamlanivimab or casirivimab/imdevimab 25 .…”

“…Similarly, Ganesh et al, in a study of more than 3,500 patients who received bamlanivimab or casirivimab/imdevimab, referred broadly to immunocompromised status, which is one of the inclusion criteria under the EUA 8 . In a retrospective cohort study by Jalbert et al 9 that included more than 13,000 patients who received casirivimab/imdevimab, patients with cancer or chemotherapy were included as a separate category for cohort-matching purposes, but their malignancy characteristics were not described, nor the direct effect of mAbs on this subpopulation. And in the COMET-ICE randomized clinical trial for sotrovimab, patients with cancer receiving immunosuppressive chemotherapy or immunotherapy were explicitly excluded 7 .…”

“…Several clinical trials [5][6][7] and observational studies 8,9 have established the protective role of anti-spike monoclonal antibodies (mAbs) in reducing the severity of clinical outcomes among eligible outpatients.…”