J Korean Med Sci.  2022 Apr;37(13):e102. 10.3346/jkms.2022.37.e102.

Effectiveness and Safety of Regdanvimab in Patients With Mild-ToModerate COVID-19: A Retrospective Cohort Study

• Park S
• Je NK
• Kim DW
• Park M
• Heo J

• KMID: 2527829
• DOI: http://doi.org/10.3346/jkms.2022.37.e102

Abstract

Background
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 2/3 randomized controlled trial. More information is needed about the effects and safety of regdanvimab.
Methods
We analyzed data for 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 treated with and without regdanvimab. The primary outcome was in-hospital death or disease aggravation which means the need for oxygen therapy (low- or high-flow oxygen therapy and mechanical ventilation) and secondary outcomes comprised the length of hospital stay and adverse reactions.
Results
Among 1,617 selected patients, 970 (60.0%) were indicated for regdanvimab. Of these, 377 (38.9%) were administered with regdanvimab. Among a 1:1 PS-matched cohort of 377 patients each treated with and without regdanvimab, 19 (5%) and 81 (21.5%) reached the composite outcome of death, or disease aggravation, respectively (absolute risk difference, −16.4%; 95% confidence interval [CI], −21.1, −11.7; relative risk difference, 76.5%; P < 0.001). Regdanvimab significantly reduced the composite outcome of death, or disease aggravation in univariate (odds ratio [OR], 0.194; 95% CI, 0.112–0.320; P < 0.001) and multivariableadjusted analyses (OR, 0.169; 95% CI, 0.095–0.289; P < 0.001). The hospital stay was shorter for the group with than without regdanvimab. Some hematological adverse reactions were more frequent in the group without regdanvimab, but other adverse reactions did not significantly differ between the groups.
Conclusion
Regdanvimab was associated with a significantly lower risk of disease aggravation without increasing adverse reactions.

Keyword

Regdanvimab; Monoclonal; Antibody; Mild-to-Moderate; COVID-19; Effectiveness

Figure

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  Fig. 1 Flow chart of the study cohort.COVID-19 = coronavirus disease 2019, BMC = Busan Medical Center.

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  Fig. 2 Forest plot for effects of regdanvimab on composite outcome of death, or disease aggravation in sensitivity analyses. Sensitivity analyses were performed by changing the covariates included in the PS estimation model (PS1–5), changing the matching method (PS5-nearest), and adding covariates in the multivariable logistic regression model of analyzing the matching data (MLR-therapeutics and laboratory data). The covariates included in each PS estimation model are as follows; PS5 included variables corresponding to the regdanvimab administration criteria of European Medicines Agency and gender according to clinical judgment (age, sex, BMI, cardiovascular disease, chronic lung disease, diabetes mellitus, hypertension, chronic kidney disease, chronic liver diseases, and pneumonia); PS1 included all measured covariates (age, sex, BMI, cardiovascular disease, chronic lung disease, diabetes mellitus, hypertension, chronic kidney disease, chronic liver diseases, pneumonia, ACEIs/ARBs, statins, aspirin, and immunomodulators); PS2 included variables that were statistically significant for both exposure and outcome, and significant for outcome (age, cardiovascular disease, hypertension, chronic kidney disease, and pneumonia); For PS3, variables corresponding to the Korean regdanvimab administration criteria were included according to clinical judgment (age, cardiovascular disease, chronic lung disease, diabetes mellitus, hypertension, and pneumonia); PS4 included variables of PS3 and what significant for outcome (age, cardiovascular disease, chronic lung disease, diabetes mellitus, hypertension, chronic kidney disease, and pneumonia). PS5-nearest was the result of performing nearest matching by designating a caliper, which was 0.094 (0.2 of the standard deviation of the logit of the PS). MLR-therapeutics was the result of adding other treatment exposures (azithromycin, corticosteroids, hydroxychloroquine, lopinavir/ritonavir, and remdesivir), and MLR-laboratory data was that of adding the baseline laboratory data (C-reactive protein, lactate dehydrogenase, D-dimer, troponin I, ferritin, and creatine kinase).OR = odds ratio, CI = confidence interval, PS = propensity score, MLR = multivariable logistic regression, BMI = body mass index, ACEI = angiotensin-converting enzyme inhibitor, ARB = angiotensin-receptor blocker.Variables of significance (***P < 0.001).

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