Effectiveness and safety of regdanvimab in patients with mild-to-moderate COVID-19: A retrospective cohort study

Abstract

Regdanvimab has decreased the time to clinical recovery from coronavirus disease 2019 (COVID-19) and lowered the rate of oxygen therapy according to the results from Phase 2 randomized controlled trial. More information is needed about the effects and safety of regdanvimab. We analyzed the medical records of patients with high-risk mild or moderate COVID-19 being admitted to Busan Medical Center between December 1, 2020, and April 16, 2021. A propensity score (PS) matched analysis was conducted to compare patients with and without regdanvimab. The primary outcome was in-hospital death or disease aggravation. Among 1,617 selected patients, 970 (60.0%) were indicated for regdanvimab. Among a 1:1 PS-matched cohort of 377 patients each treated with and without regdanvimab, regdanvimab significantly reduced the primary endpoint (odds ratio [OR], 0.194; 95% confidence interval [CI], 0.112–0.320; p < 0.001). Regdanvimab was associated with a significantly lower risk of disease aggravation without increasing adverse reactions.

Regdanvimab: First Approval

“…Increased age, male gender, higher body mass index and concurrent pneumonia were associated with increased odds of reaching the primary endpoint. Results for the overall cohort ( n = 377 for regdanvimab and 520 for no regdanvimab) were generally similar to those for the PSM cohort [ 20 ].…”

“…In a single-centre, retrospective, propensity score-matched (PSM) cohort study of patients with high-risk mild or moderate COVID-19, regdanvimab treatment was associated with a significant ( p < 0.001) reduction in the proportion of patients reaching the composite of death or disease aggravation versus no regdanvimab treatment (5.0% vs 21.5%; n = 377 in each group; primary endpoint) [ 20 ]. The odds ratios (95% CI) were 0.194 (0.112–0.320) and 0.169 (0.095–0.287) in univariate and multivariable-adjusted analyses, respectively ( p < 0.001 for both).…”

“…In the PSM cohort study, regdanvimab treatment was associated with significantly ( p < 0.001 vs no regdanvimab treatment) lower incidences of white blood cells increased (> 10 × 10 3 /µL; 5.0 vs 11.9%) or decreased (< 4 × 10 3 /µL; 7.7 vs 14.9%), decreased platelet counts (< 130 × 10 3 /µL; 2.4 vs 5.8%) and decreased absolute lymphocyte count (< 800/µL; 2.9 vs 11.9%) [ 20 ]. The two groups did not differ significantly for other investigated adverse reactions (renal and liver toxicity, gastrointestinal toxicity, fever or systemic pain, hypersensitivity, haemoglobin, absolute neutrophil count, and serum sodium and potassium abnormalities) [ 20 ].…”

Efficacy and safety of regdanvimab in patients with mild to moderate COVID‐19: A rapid review and meta‐analysis

“…Out of a total of 138 studies after removing duplicates, 12 full-text studies were assessed for eligibility. Four studies were excluded due to irrelevant data, 22,27 combination therapy 28 or review article. 29 Finally, 8 studies 16,20,21,[30][31][32][33][34] including 2 RCTs 16,32 and 6 observational studies 20,21,30,31,33,34 with 4793 patients were considered in the meta-analysis.…”

Real-World Efficacy of Regdanvimab on Clinical Outcomes in Patients with Mild to Moderate COVID-19

“…Our study showed that regdanvimab was associated not only with a decreased need for oxygen supplementation but also with reducing remdesivir and dexamethasone requirements by 90% and 85%, respectively. In another study, regdanvimab usage reduced death, oxygen supplementation, and the need for intensive care unit care by 83.1% (95% CI, 71.3–90.5) [ 11 ]. Although the proportion of patients with disease progression was slightly lower in the present study, the difference could be attributed to the heterogeneity in defining clinical outcomes and the younger age of patients receiving regdanvimab (46.9 vs. 61 years) in our study.…”