Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea

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..

Medienart:	E-Artikel

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	Zur Gesamtaufnahme - volume:12
Enthalten in:	Infectious diseases and therapy - 12(2023), 10 vom: Okt., Seite 2417-2435

Sprache:	Englisch

Beteiligte Personen:

Lee, Ji Yeon [VerfasserIn] Bu, Seon Hee [VerfasserIn] Song, EunHyang [VerfasserIn] Cho, Seongcheol [VerfasserIn] Yu, Sungbong [VerfasserIn] Kim, Jungok [VerfasserIn] Kym, Sungmin [VerfasserIn] Seo, Kwang Won [VerfasserIn] Kwon, Ki Tae [VerfasserIn] Kim, Jin Yong [VerfasserIn] Kim, Sunghyun [VerfasserIn] Ahn, Keumyoung [VerfasserIn] Jung, Nahyun [VerfasserIn] Lee, Yeonmi [VerfasserIn] Jung, Yoobin [VerfasserIn] Hwang, Chankyoung [VerfasserIn] Park, Sang Won [VerfasserIn]

Links:	Volltext [kostenfrei]

Themen:	COVID-19 CT-P59 Effectiveness Monoclonal antibody Neutralising antibody Post-marketing surveillance Regdanvimab SARS-CoV-2 Safety

Anmerkungen:	© The Author(s) 2023

doi:	10.1007/s40121-023-00859-1

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	SPR053526864