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Casirivimab-Imdevimab Treatment in Mild to Moderate COVID-19: A Real-World Evidence
Casirivimab and Imdevimab are two non-competing, high-affinity human IgG1 anti-SARS- CoV-2 monoclonal antibodies that bind non-competitively to the COVID-19 virus-cell surface and prevents the virus from infecting healthy cells. Casirivimab-imdevimab is an anti- spike monoclonal antibody that has been authorized for use, Emergency Use Authorization by US FDA on November 21, 2020, and in India for restricted use in an emergency situation by DCGI on 03 May 2021. The current retrospective real-world cohort study aimed to assess the outcomes of casirivimab-imdevimab treatment in mild to moderate COVID-19 patients.
Study Design
• Study included 1392 high-risk patients (Casirivimab Imdevimab cohorts, n = 696 and control cohorts, n = 69ó) with mild to moderate COVID- 19.
Inclusion Criteria
Patients of age ≥ 18 years with symptoms of mild to moderate COVID-19 (e.g., cough, sore throat, headache, body aches, fever, and constitutional symptoms), were within 10 days of symptom onset, and had at least one of the following criteria:
- Age ≥ 65 years, Body mass index (BMI) is ≥ 35
- Diabetes mellitus, CKD, immunosuppressive medication use, or an immunocompromising condition.
- Patients ≥ 55 years qualified if they had hypertension, cardiovascular disease, or chronic lung disease.
Dosing
All patients received a one-hour infusion of casirivimab (1200-mg dose) and imdevimab (1200-mg dose). Antiviral drugs or immunomodulatory treatments (remdesivir or corticosteroid) were not provided to patients.
Outcome
Clinical outcomes assessed at days l4, 21, and 28 after enrollment were hospitalization rates (primary), ICU admission, and death (secondary).
Results
The median age of the antibody-treated cohort was 63 years (interquartile range, 52-71);45.5% ≥ 65 years old: 51.4% were female.
- High-risk characteristics were hypertension (52.4%), body mass index ≥ 35 (31.0%), diabetes mellitus (24.6%), chronic lung disease (22.1%), chronic renal disease (11.4%), congestive heart failure(6.6%), and compromised immune function (6.7%).
All-cause hospitalization
• All-cause hospitalization rates were significantly lower in the casirivimab-imdevimab group than the propensity-matched cohort:
• At day 14(1.3%vs 3.3%:Absolute Difference: 2.0%: 95% CI:0.50-3.7%)
• At day 21(1.3% vs 4.2%: Absolute Difference: 2.9%: 95% CI: 1.2% - 4.7%)
• At day 28 ( 1.6% vs 4.8%: Absolute Difference: 3.2%: 95% CI:1.4-5.1%)
• Patients who were treated with casirivimab - imdevimab had significantly more hospitalization-free days.
Intensive care unit admissions and all-cause mortality
• All-cause ICU admission rates were similarly low and were not significantly different between the casirivimab-imdevimab-treated and the untreated cohorts
• Five patients died from any cause (among which only one patient received casirivimab-imdevimab).
Adverse events
- Adverse events were reported in seven patients [fever (n=4), shortness of breath (n=2), nausea(n=2), chest pain, headache, or flushing (n=1)].
- No patient had anaphylaxis. All adverse events were mild (NCI Grade 1) and did not require hospitalization.
Among high-risk patients with mild to moderate COVID-19, casirivimab-imdevimab treatment was associated with a significantly lower rate of hospitalization with uncommon and mild adverse events.
Clinical Implication
The clinical outcomes in this study complement the virologic outcomes data in the randomized controlled trial and collectively provide data to support the use of casirivimab-imdevimab as early treatment of high-risk patients with mild to moderate COVID-19.
For more details about the prescribing information, click here
Reference:
"Razonable RR, Pawlowski C, O'Horo JC, et al. Casirivimab-lmdevimab treatment is associated with reduced rates of hospitalization among high-risk patients with mild to moderate coronavirus disease-19. EClinicalMedicine. 2021Aug 30:101102. doi: 10.101ó/j.eclinm.2021.101102. Epub ahead of print.
Disclaimer: This article has been published under MD Brand Connect Initiative.
Disclaimer: This content and information provided is intended for update strictlyforRegistered MedicalPractitioners/ Physicians treating Covid 19 only. The information mentioned herein is not intended nor implied to be a substitute for professional medical advice. Any advice regarding the management of any medical condition is totally in the discretion of doctor (Registered Medical Practitioner)/ physician treating Covid 19 patients. Prescription of the drug is the prerogative of doctors (Registered Medical Practitioner/ Physician treating Covid 19) at his /her sole discretion. Physicians treating Covid 19 patients must refer to the fullprescribing information of the product for use of product. Copying, reproduction, circulation of the information published here in any form or by any means either mechanically/ print or electronically without prior consent is strictly prohibited. Any unauthorised person having possession of this document should discard the same or inform/ notify/ return to Cipla Ltd. To report any adverse events/special situation with Cipla medicinal products email at drugsafety@cipla.com. or via the national Pharmacovigilance Programme of India by calling on 1800267 7779 (Cipla number) or you can report to PvPI on 1800 180 3024. By reporting side effects, you can help provide more information on the safetyofthis product. For complete prescribing information, please login www.ciplamed.com.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751