Bamlanivimab + etesevimab combo reduces COVID-19-related hospitalization, any-cause death in high-risk patients

The combination of bamlanivimab and etesevimab reduces the risk of COVID-19-related hospitalization and any-cause death in high-risk ambulatory patients, particularly those with diabetes, according to the BLAZE-1* study presented at EASD 2021.

“Patients with underlying medical conditions, such as diabetes, are at greater risk of severe COVID-19. [Bamlanivimab and etesevimab are] neutralizing monoclonal antibodies [that] provide immediate, passive humoral immunotherapy, with the potential to reduce disease progression, hospitalizations, and death,” said study author Dr Dipak Patel from Eli Lilly and Company in Indianapolis, Indiana, US.

This ongoing portion of the phase III study evaluated 1,035 outpatients (aged ≥12 years) with mild-to-moderate COVID-19 who were randomized to receive a single intravenous infusion of bamlanivimab and etesevimab (2,800 mg each; n=518) or placebo (n=517) within 3 days of diagnosis. Overall, 25.9–29.2 percent of the participants either had type 1 or type 2 diabetes. [EASD 2021, abstract 692]

On day 29, patients treated with bamlanivimab + etesevimab achieved a 70.0 percent reduction in the risk of COVID-19-related hospitalization or any-cause death compared with placebo in the overall population (2.1 percent vs 7.0 percent; p=0.0004).

Similarly, in a subgroup of patients with diabetes, those on bamlanivimab + etesevimab achieved a 73.0 percent reduction in the risk of COVID-19-related hospitalization or any-cause death by day 29 than those on placebo (2.6 percent vs 9.7 percent; p=0.0210).

Bamlanivimab + etesevimab recipients also had significantly reduced viral loads than placebo recipients from baseline to day 7 (mean viral load [log10 scale] 2.87 vs 4.05; p<0.001), with a shorter time to sustained symptom resolution (median 8 vs 9 days; p=0.007).

Overall, no cases of death from any cause occurred in the bamlanivimab + etesevimab group, while 10 cases, mostly related to COVID-19, occurred in the placebo group.

The rates of adverse events were comparable between the bamlanivimab + etesevimab and placebo groups (13.3 percent vs 11.6 percent).

“This phase III [study] confirms and replicates phase II findings [that bamlanivimab + etesevimab] combination therapy significantly reduced COVID-related hospitalizations and deaths [in the overall population and subgroup of patients with diabetes], … and accelerated the decline in viral load and disease symptoms over time,” said Patel.

“These results reflected the potential of bamlanivimab and etesevimab together in protecting patients with diabetes, or generally, this supported potential for neutralizing monoclonal antibodies in decreasing mortality, burden on the healthcare system, and duration of symptomatic disease in high-risk COVID-19 patients,” Patel noted.

Patel highlighted that the bamlanivimab and etesevimab combination has received emergency use authorization in multiple countries around the world.