Regdanvimab in patients with mild-to-moderate SARS-CoV-2 infection: A propensity score-matched retrospective cohort study

Abstract

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.

Keywords: COVID-19; CT-P59; Outcome; Pneumonia.

Fig. 1

Schematic representation of regdanvimab binding to the receptor-binding domain of SARS-CoV-2. Steric hindrance caused by regdanvimab prevents SARS-CoV-2 binding to the angiotensin-converting enzyme 2 receptor on host cells, blocking virus entry. ACE2, angiotensin-converting enzyme 2; Fab: fragment antigen binding; Fc: fragment crystallizable; RBD, receptor-binding domain; S, spike protein.

Fig. 2

Patient flow diagram. *The three medical centers were Kyungpook National University Chilgok Hospital, Kyungpook National University Hospital and Pusan National University Hospital. ^†Some patients were excluded based on more than one factor. ^‡Severe illness – individuals with oxygen saturation (SpO₂) < 94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen < 300 mmHg, respiratory frequency > 30 breaths/minute or lung infiltrates > 50%; and critical illness – individuals with respiratory failure, septic shock and/or multiple organ dysfunction. ^§SpO₂ is for use in patients with hypercapnic respiratory failure who have clinically recommended oxygen saturation of 88–92%. BMI, body mass index; SoC, standard of care. ^¶Patients without medical cost information were excluded from the medical utilization analysis.