Regdanvimab in patients with mild-to-moderate SARS-CoV-2 infection : A propensity score-matched retrospective cohort study
Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved..
BACKGROUND: Regdanvimab (CT-P59) is a neutralizing antibody authorized in Republic of Korea for the treatment of adult patients with moderate or mild-COVID-19 who are not on supplemental oxygen and have high risk of progressing to severe disease (age ≥ 50 years or comorbidities). This study evaluated the clinical efficacy, safety and medical utilization/costs associated with real-world regdanvimab therapy.
METHODS: This non-interventional, retrospective cohort study included adult patients with confirmed mild-to-moderate SARS-CoV-2 infection. Patients treated with regdanvimab were compared with controls who had received other therapies. The primary endpoint was the proportion of patients progressing to severe/critical COVID-19 or death due to SARS-CoV-2 infection up to Day 28. Propensity score matching was applied to efficacy analyses.
RESULTS: Overall, 552 patients were included in the Safety and Efficacy Sets (regdanvimab, n = 156; control, n = 396) and 274 patients in the propensity score-matched (PSM) Efficacy Set (regdanvimab, n = 113; control, n = 161). In the PSM Set, the risk of severe/critical COVID-19 or death was significantly lower in the regdanvimab group (7.1% vs 16.1%, P = 0.0263); supplemental oxygen was required by 8.0% and 18.6% of patients in the regdanvimab and control groups, respectively (P = 0.0128). There were no unexpected safety findings in the regdanvimab group. Medical utilization analysis showed an overall cost reduction with regdanvimab compared with control treatments.
CONCLUSIONS: Regdanvimab significantly reduced the proportion of patients progressing to severe/critical disease or dying of SARS-CoV-2 infection. This study shows the potential benefits of regdanvimab in reducing disease severity and improving medical utility in patients with COVID-19.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:106 |
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| Enthalten in: |
International immunopharmacology - 106(2022) vom: 09. Mai, Seite 108570 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lee, Shinwon [VerfasserIn] |
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| Links: |
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| Themen: |
Antibodies, Monoclonal, Humanized |
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| Anmerkungen: |
Date Completed 06.04.2022 Date Revised 07.12.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.intimp.2022.108570 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM337000786 |
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| 100 | 1 | |a Lee, Shinwon |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Regdanvimab in patients with mild-to-moderate SARS-CoV-2 infection |b A propensity score-matched retrospective cohort study |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved. | ||
| 520 | |a BACKGROUND: Regdanvimab (CT-P59) is a neutralizing antibody authorized in Republic of Korea for the treatment of adult patients with moderate or mild-COVID-19 who are not on supplemental oxygen and have high risk of progressing to severe disease (age ≥ 50 years or comorbidities). This study evaluated the clinical efficacy, safety and medical utilization/costs associated with real-world regdanvimab therapy | ||
| 520 | |a METHODS: This non-interventional, retrospective cohort study included adult patients with confirmed mild-to-moderate SARS-CoV-2 infection. Patients treated with regdanvimab were compared with controls who had received other therapies. The primary endpoint was the proportion of patients progressing to severe/critical COVID-19 or death due to SARS-CoV-2 infection up to Day 28. Propensity score matching was applied to efficacy analyses | ||
| 520 | |a RESULTS: Overall, 552 patients were included in the Safety and Efficacy Sets (regdanvimab, n = 156; control, n = 396) and 274 patients in the propensity score-matched (PSM) Efficacy Set (regdanvimab, n = 113; control, n = 161). In the PSM Set, the risk of severe/critical COVID-19 or death was significantly lower in the regdanvimab group (7.1% vs 16.1%, P = 0.0263); supplemental oxygen was required by 8.0% and 18.6% of patients in the regdanvimab and control groups, respectively (P = 0.0128). There were no unexpected safety findings in the regdanvimab group. Medical utilization analysis showed an overall cost reduction with regdanvimab compared with control treatments | ||
| 520 | |a CONCLUSIONS: Regdanvimab significantly reduced the proportion of patients progressing to severe/critical disease or dying of SARS-CoV-2 infection. This study shows the potential benefits of regdanvimab in reducing disease severity and improving medical utility in patients with COVID-19 | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Pneumonia | |
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| 700 | 1 | |a Lee, Jeong Eun |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Kye-Hyung |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Sun Hee |e verfasserin |4 aut | |
| 700 | 1 | |a Hwang, Soyoon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Shin-Woo |e verfasserin |4 aut | |
| 700 | 1 | |a Chang, Hyun-Ha |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Yoonjung |e verfasserin |4 aut | |
| 700 | 1 | |a Bae, Sohyun |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, A-Sol |e verfasserin |4 aut | |
| 700 | 1 | |a Kwon, Ki Tae |e verfasserin |4 aut | |
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