Impact of Antibody Cocktail Therapy Combined with Casirivimab and Imdevimab on Clinical Outcome for patients with COVID-19 in A Real-Life Setting: A Single Institute Analysis

Kakinoki, Yasutaka; Yamada, Kazuki; Tanino, Yoko; Suzuki, Keiko; Ichikawa, Takaya; Suzuki, Naoki; Asari, Go; Nakamura, Ai; Kukita, Shin; Uehara, Akito; Saito, Seisuke; Kuroda, Shohei; Sakagami, Hidemitsu; Nagashima, Yuuki; Takahashi, Kihito; Suzuki, Satoshi

doi:10.1016/j.ijid.2022.01.067

Cited by 13 publications

(13 citation statements)

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“…The results of this real-world study are consistent with the results of the phase-III clinical trial, which showed that treatment with REGEN-COV reduced the risk of hospitalization or death by 70.4% in the 28 days following treatment initiation 12 . They are also consistent with the results of an observational study that showed a 70% reduction in the need for further treatment among those treated with REGEN-COV 9 . Importantly, the effectiveness of REGEN-COV has recently been reported to be diminished against the Omicron variant, which has become dominant in many regions worldwide.…”

Section: Discussionsupporting

confidence: 89%

“…The efficacy of REGEN-COV has been demonstrated in clinical trials [5][6][7] , where it was shown to reduce symptomatic COVID-19 illness by 62% and COVID-19related hospitalization or death by 70% in the first month after treatment 5 . Evidence suggests that the benefits are greater when REGEN-COV is administered within the first five days following infection 8,9 .…”

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confidence: 99%

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Effectiveness of REGEN-COV antibody combination in preventing severe COVID-19 outcomes

et al. 2022

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REGEN-COV, a combination of the monoclonal antibodies casirivimab and imdevimab, has been approved as a treatment for high-risk patients infected with SARS-CoV-2 within five days of their diagnosis. We performed a retrospective cohort study, and used data repositories of Israel’s largest healthcare organization to determine the real-world effectiveness of REGEN-COV treatment against COVID-19-related hospitalization, severe disease, and death. We compared patients infected with Delta variant and treated with REGEN-COV (n = 289) to those infected but not-treated with REGEN-COV (n = 1,296). Demographic and clinical characteristics were used to match patients and for further adjustment as part of the C0x model. Estimated treatment effectiveness was defined as one minus the hazard ratio. Treatment effectiveness of REGEN-COV was 56.4% (95% CI: 23.7–75.1%) in preventing COVID-19 hospitalization, 59.2% (95% CI: 19.9–79.2%) in preventing severe COVID-19, and 93.5% (95% CI: 52.1–99.1%) in preventing COVID-19 death in the 28 days after treatment. In conclusion, REGEN-COV was effective in reducing the risk of severe sequelae in high-risk COVID-19 patients.

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Section: Discussionsupporting

confidence: 89%

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confidence: 99%

Effectiveness of REGEN-COV antibody combination in preventing severe COVID-19 outcomes

et al. 2022

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“…While multiple studies have reported on the real-world effectiveness of CAS+IMD [4][5][6][7][8][9][10][11][12][13][14][15][16], most only included a small number of CAS+IMD-treated patients, generally evaluating the early experience with monoclonal antibodies (mAbs), were single-center, and did not have sufficient sample size to assess effectiveness of CAS+IMD across various patient subgroups. Studies leveraging large databases with sufficient counts to assess the effectiveness of CAS+IMD in subgroups of patients at higher risk of poor outcomes are needed.…”

Section: Discussionmentioning

confidence: 99%

Real-world Effectiveness of Casirivimab and Imdevimab in Patients With COVID-19 in the Ambulatory Setting: An Analysis of Two Large US National Claims Databases

Murdock

Jalbert

Mastey

et al. 2022

Preprint

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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.

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“…While the majority of real-world studies assessing the effectiveness of CAS+IMD reported 50%-78% reductions in the risk of hospitalization, [10][11][12][13][14][15][16][17][18][19][20][21][22][23] the effectiveness of SC CAS+IMD was not specifically assessed. A study that did evaluate SC CAS+IMD reported that treated patients were 56% less likely to be hospitalized or die than untreated patients.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of Subcutaneous Casirivimab and Imdevimab Relative to no COVID-19 Antibody Treatment Among Patients Diagnosed With COVID-19 in the Ambulatory Setting

Jalbert

Hussein

Mastey

et al. 2022

Preprint

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ImportanceData on real-world effectiveness of subcutaneous (SC) administration of casirivimab and imdevimab (CAS+IMD) for treatment of COVID-19 are limited.ObjectiveTo assess effectiveness of SC CAS+IMD vs no COVID-19 antibody treatment among patients diagnosed with COVID-19 in ambulatory settings during the Delta-dominant period prior to Omicron emergence.DesignRetrospective cohort study.SettingEncrypted linked data between Komodo Health closed claims database and CDR Maguire Health & Medical database.ParticipantsPatients with COVID-19 in ambulatory settings between August 1, 2021 and October 30, 2021 treated with SC CAS+IMD were exact- and propensity score-matched to up to 5 untreated patients who were treatment-eligible under the Emergency Use Authorization (EUA)ExposureSubcutaneous CAS+IMD.Main Outcomes and MeasuresComposite endpoint of 30-day all-cause mortality or COVID- 19-related hospitalization. Kaplan-Meier estimators were used to calculate composite risk overall and across subgroups including age, COVID-19 vaccination status, immunocompromised, and elevated risk defined as age ≥ 65 years or 55-64 years with body mass index ≥ 35 kg/m2, type 2 diabetes, chronic obstructive pulmonary disease, or chronic kidney disease. Cox proportional- hazards models were used to estimate adjusted hazard ratios (aHR) and 95% confidence intervals (CI).ResultsAmong 13 522 patients treated with SC CAS+IMD, 12 972 (95.9%) were matched to 41 848 EUA-eligible untreated patients; patients were 57-58% female, with mean age between 50 and 52 years. The 30-day composite outcome risk was 1.9% (95% CI, 1.7-2.2; 247 events) and 4.4% (95% CI, 4.2-4.6; 1822 events) in the CAS+IMD-treated and untreated cohorts, respectively; CAS+IMD treatment was associated with a 49% lower risk (aHR 0.51; 95% CI, 0.46-0.58). Treatment was also associated with a 67% lower 30-day risk of all-cause mortality (aHR 0.33, 95% CI, 0.18-0.60). Treatment effectiveness was consistent regardless of vaccination status and across subgroups, including those at elevated risk (aHR 0.51, 95% CI 0.42-0.60) or immunocompromised (aHR 0.34, 95% CI 0.17-0.66).Conclusions and RelevanceSubcutaneous treatment with CAS+IMD is effective for reducing all-cause mortality or COVID-19-related hospitalization in patients diagnosed with COVID-19 and managed in real-world outpatient settings during the Delta-dominant period. Effectiveness is maintained among immunocompromised, vaccinated, and elevated risk patients.

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Impact of Antibody Cocktail Therapy Combined with Casirivimab and Imdevimab on Clinical Outcome for patients with COVID-19 in A Real-Life Setting: A Single Institute Analysis

Cited by 13 publications

References 14 publications

Effectiveness of REGEN-COV antibody combination in preventing severe COVID-19 outcomes

Effectiveness of REGEN-COV antibody combination in preventing severe COVID-19 outcomes

Real-world Effectiveness of Casirivimab and Imdevimab in Patients With COVID-19 in the Ambulatory Setting: An Analysis of Two Large US National Claims Databases

Effectiveness of Subcutaneous Casirivimab and Imdevimab Relative to no COVID-19 Antibody Treatment Among Patients Diagnosed With COVID-19 in the Ambulatory Setting

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