Infectious Disease

Monoclonal antibody combinations appear to be equally effective against COVID-19

16.09.2021

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In the largest comparative randomized study of the treatment of COVID-19 with monoclonal antibodies, two regimens – bamlanivimab / etesevimab and casirivimab / imdevimab – were safe and appeared to be equally effective, according to a press release.

In the OPTIMISE-C19 study, researchers from the University of Pittsburgh Medical Center compared the effectiveness of the combination regimens, both of which were FDA approved for patients with mild to moderate COVID-19.

McCreary EK et al. medRxiv. 2021; doi: 10.1101 / 2021.09.03.21262551.

“Before the introduction of OPTIMISE-C19, only a small percentage of eligible patients received treatment with monoclonal antibodies.” Erina McCreary, PharmD, An infectious disease pharmacist and clinical assistant professor of medicine at the University of Pittsburgh School of Medicine said in the press release. “We are now able to offer monoclonal antibodies as part of a clinical trial at each of our available treatment centers – resulting in a 7.5-fold increase in the number of eligible patients receiving this treatment.”

McCreary and colleagues randomly assigned 1,935 patients with mild to moderate COVID-19 to bamlanivimab (Eli Lilly & Co.) alone, bamlanivimab / etesevimab (Eli Lilly & Co.), or casirivimab / imdevimab (REGEN-COV, Regeneron). The treatments were administered within 10 days of the onset of symptoms. The patients were then observed for 28 days.

Between March 10 and June 25, McCreary and colleagues assigned 128 patients to be treated with bamlanivimab, 885 patients to be treated with bamlanivimab / etesevimab, and 922 patients to be treated with casirivimab / imdevimab. The mean age of the patients was between 55 and 57 years; about half were women; and 17% were black.

When compared to bamlanivimab / etesevimab and casirivimab / imdevimab, bamlanivimab alone gave a probability of inferiority of 91% and 94%, respectively. According to the researchers, the two combination therapies showed an 86% probability of effectiveness being equivalent.

As previously reported by Healio Primary Care, the combination treatment of bamlanivimab / etesevimab received emergency approval (EUA) from the FDA in February. Casirivimab / Imdevimab received an EUA in November 2020.

The EEA for Bamlanivimab / Etesevimab was based on data from a placebo-controlled study that showed that an IV infusion of combination treatment in patients with COVID-19 who were at high risk of disease progression.

The EEA for casirivimab / imdevimab was based on the results of a randomized, double-blind, placebo-controlled study. The study found that only 3% of patients who received the treatment were hospitalized or visited the emergency room, compared with 6% of those who received placebo.

Both combination treatments were approved for patients 12 years of age and over who weighed at least 88 pounds who tested positive for SARS-CoV-2.

David T. Huang

“As soon as new treatments are approved, we can immediately start offering them to patients and collecting randomized data to inform future treatment protocols. We can then compare the results as the virus develops and new variants emerge. ” David T. Huang, MD, MPH, A professor of critical care medicine, emergency medicine and translational science at the University of Pittsburgh School of Medicine said in the press release.

Healio Primary Care spoke to Huang to learn more about monoclonal antibody treatment.

Healio primary care: What is the message of your study for doctors?

Huang: Monoclonal antibodies are effective treatments for keeping patients with COVID-19 out of the hospital. Which is best is the quickest answer you can give your patient right now.

Healio primary care: Who are the ideal candidates for this treatment?

Huang: According to the FDA-EUAs, ideal candidates are patients with mild to moderate COVID-19 shortly after the onset of symptoms at a high risk of worsening (e.g. patients with comorbidities, older age, higher BMI).

Healio primary care: Does the effectiveness of the treatment depend on which variant a patient is infected with?

Huang: Our study did not measure variants directly at the patient level, but found no difference in comparative effectiveness over time. However, the alpha variant was dominant during the entire trial period from March to June, with Delta only prevailing at the end, so this question is still open.

Healio basic care: What are the side effects associated with this treatment that doctors should be aware of?

Huang: According to the EUAs, there are rare events such as allergic reactions. In our 1,935 patient study, 21 patients (1%) experienced adverse events, of which only 5 (0.26%) were classified as serious.

Healio basic care: When do you think the treatments will be approved by the FDA?

Huang: It’s hard to predict. The focus of the FDA is currently on the approval of vaccines.

Healio basic care: How do you approach patients who may really need this treatment but are skeptical or suspicious?

Huang: I would advise patients that monoclonal antibodies are safe, effective, and can keep them out of the hospital and keep them alive.

Healio basic care: Is there anything else to add?

Huang: The OPTIMISE-C19 study continues to evaluate all available monoclonal antibodies as a learning health system study and we hope to provide further comparative efficacy data soon given the delta.

References:

FDA. COVID-19 Update: FDA Approves Monoclonal Antibodies To Treat COVID-19. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonale-antibodies-treatment-covid-19-0. February 10, 2021.

McCreary EK et al. medRxiv. 2021; doi: 10.1101 / 2021.09.03.21262551.

McGinley L and Johnson CY. An experimental drug administered to Trump to treat Covid-19 gains FDA approval. https://www.washingtonpost.com/health/2020/11/21/regeneron-fda-clearance/. Accessed November 23, 2020.

UPMC. UPMC and Pitt deliver initial results of largest comparative randomized study on treatment with monoclonal antibodies against COVID-19. https://www.upmc.com/media/news/090821-optimise-interim. Accessed on September 13, 2021.

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