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Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea
DC Field | Value | Language |
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dc.contributor.author | Lee, Ji Yeon | - |
dc.contributor.author | Bu, Seon Hee | - |
dc.contributor.author | Song, EunHyang | - |
dc.contributor.author | Cho, Seongcheol | - |
dc.contributor.author | Yu, Sungbong | - |
dc.contributor.author | Kim, Jungok | - |
dc.contributor.author | Kym, Sungmin | - |
dc.contributor.author | Seo, Kwang Won | - |
dc.contributor.author | Kwon, Ki Tae | - |
dc.contributor.author | Kim, Jin Yong | - |
dc.contributor.author | Kim, Sunghyun | - |
dc.contributor.author | Ahn, Keumyoung | - |
dc.contributor.author | Jung, Nahyun | - |
dc.contributor.author | Lee, Yeonmi | - |
dc.contributor.author | Jung, Yoobin | - |
dc.contributor.author | Hwang, Chankyoung | - |
dc.contributor.author | Park, Sang Won | - |
dc.date.accessioned | 2023-10-16T01:09:48Z | - |
dc.date.available | 2023-10-16T10:11:32Z | - |
dc.date.issued | 2023-10-13 | - |
dc.identifier.citation | Infectious Diseases and Therapy, Vol.2023 | ko_KR |
dc.identifier.uri | https://doi.org/10.1007/s40121-023-00859-1 | - |
dc.identifier.uri | https://hdl.handle.net/10371/195777 | - |
dc.description.abstract | Introduction
Regdanvimab, a neutralising monoclonal antibody (mAb) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), received approval for the treatment of coronavirus disease 2019 (COVID-19) in South Korea in 2021. The Ministry of Food and Drug Safety in South Korea mandate that new medications be re-examined for safety and effectiveness post-approval in at least 3000 individuals. This post-marketing surveillance (PMS) study was used to evaluate the safety and effectiveness of regdanvimab in real-world clinical care. Methods This prospective, multicentre, phase 4 PMS study was conducted between February 2021 and March 2022 in South Korea. Eligible patients were aged ≥ 18 years with confirmed mild COVID-19 at high risk of disease progression or moderate COVID-19. Patients were hospitalised and treated with regdanvimab (40 mg/kg, day 1) and then monitored until discharge, with a follow-up call on day 28. Adverse events (AEs) were documented, and the COVID-19 disease progression rate was used to measure effectiveness. Results Of the 3123 patients with COVID-19 infection identified, 3036 were eligible for inclusion. Approximately 80% and 5% of the eligible patients were diagnosed with COVID-19 during the delta- and omicron-dominant periods, respectively. Median (range) age was 57 (18–95) years, and 50.6% of patients were male. COVID-19 severity was assessed before treatment, and high-risk mild and moderate COVID-19 was diagnosed in 1030 (33.9%) and 2006 (66.1%) patients, respectively. AEs and adverse drug reactions (ADRs) were experienced by 684 (22.5%) and 363 (12.0%) patients, respectively. The most common ADR was increased liver function test (n = 62, 2.0%). Nine (0.3%) patients discontinued regdanvimab due to ADRs. Overall, 378 (12.5%) patients experienced disease progression after regdanvimab infusion, with extended hospitalisation/re-admission (n = 300, 9.9%) as the most common reason. Supplemental oxygen was required by 282 (9.3%) patients. Ten (0.3%) patients required intensive care monitoring and 3 (0.1%) died due to COVID-19. Conclusion This large-scale PMS study demonstrated that regdanvimab was effective against COVID-19 progression and had an acceptable safety profile when used in real-world clinical practice. | ko_KR |
dc.description.sponsorship | This study and the journals Rapid Service fee was funded by Celltrion Inc. (Incheon, Republic of Korea). | ko_KR |
dc.publisher | Springer | ko_KR |
dc.subject | COVID-19 | - |
dc.subject | CT-P59 | - |
dc.subject | Effectiveness | - |
dc.subject | Monoclonal antibody | - |
dc.subject | Neutralising antibody | - |
dc.subject | Post-marketing surveillance | - |
dc.subject | Regdanvimab | - |
dc.subject | Safety | - |
dc.subject | SARS-CoV-2 | - |
dc.title | Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea | ko_KR |
dc.citation.journaltitle | Infectious Diseases and Therapy | ko_KR |
dc.language.rfc3066 | en | - |
dc.rights.holder | The Author(s) | - |
dc.date.updated | 2023-10-15T03:11:15Z | - |
dc.citation.volume | 12 | ko_KR |
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