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Whoa Black Betty, Bamlanivimab!

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POSTED: December 26th, 2020
POSTED IN: EM Pulse - The Official Newsletter of MOCEP, Featured Resources, November/December 2020, Resources,

Written by Louis Jamtgaard, MD FACEP, Asst. Medical Director Mosaic Life Care

After you learn how to say Bamlanivimab (I’m told it’s bam luh NI vi mab ) you may want to spend some time familiarizing yourself with this newly authorized therapeutic agent for mild to moderate COVID-19. On November 9, 2020, the FDA granted emergency use authorization (EUA) to Eli Lilly for their experimental neutralizing antibody, Bamlanivimab.(1) Shortly thereafter, the federal government allocated 300,000 doses free of charge to states, territories, and federal entities with planned weekly distributions. The federal government has the option to purchase an additional 650,000 doses through June 2021.

As of the week of December 9-15th, Missouri has received roughly 7,050 doses. (2) I am unable to find information regarding the specific distribution within Missouri and which facilities are currently offering this treatment to Missourians, however according to HHS, “Health departments, not the federal government, determine how much Bamlanivimab eligible healthcare facilities within their respective jurisdictions will receive.”  At the facility I work in, we have already administered 50+ doses, starting in the emergency department, and now in an outpatient infusion center. Our ED Physicians have been acting as the “COVID leaders” in coordinating eligibility and treatment for our outpatient network. This decision was based on our significant experience in risk stratifying COVID patients, and finding the tranche of patients who may benefit from this treatment.

Deep dives into the evidence behind Bamlanivimab have already been published by popular EM FOAMed sites such as EM Crit and Rebel EM, and I would suggest reading those for a critical analysis into of the evidence. In addition, traditional medical journals like NEJM and JAMA have published opinion pieces regarding the challenges of monoclonal antibody treatments including Bamlanivimab.

I will provide a brief summary regarding Bamlanivimab and my opinion on how this limited treatment should be utilized.

Bamlanivimab is a synthetic neutralizing antibody intended to block SARS-CoV-2 viral attachment and entry into human cells. The antibody was designed against the spike protein and has demonstrated high binding affinity to the receptor binding domain of SARS-CoV-2. The EUA was based on the results of phase two of the BLAZE-1 trial, which demonstrated reduced need for hospitalization in those determined to be high risk for severe COVID, with 3% of the Bamlanivimab arm requiring admission versus 10% in the placebo arm.

Design: Randomized, double-blind, placebo-controlled trial

Inclusion: Age>18, positive for SARS-CoV-2 with one or more symptoms

Exclusion: Saturation of oxygen (SpO2) ≤93% on room air, respiratory rate ≥30 breaths/minute, or heart rate ≥125 beats/minute

Treatment: Participants received a single intravenous infusion of Bamlanivimab (700mg, 2800mg, or 7000mg) within 3 days of having a positive SARS-CoV-2 virologic test result

Effect: Reduction of hospitalization of 4/136 (2.9%) participants in Bamlanivimab arm versus  7/69 (10.1%) in placebo.

Subgroup analysis: patients aged ≥65 years or having a BMI ≥35 the percentage of hospitalization was 4.2% in Bamlanivimab group and 14.6% in the placebo group.(3)

Safety: There was at least one case of anaphylaxis, treated appropriately with epi/benadryl/steroids, more common minor side effects occurred including (headache, nausea, etc) 

Criticism: Study overall was quite small, so safety should be viewed with caution. In addition, the study was too small to find any mortality benefit (no one died in either arm). Furthermore, there were 3 dosages of Bamlanivimab studied, and 3 primary outcomes, so the single positive outcome (reduced hospitalization in 700mg group) should be viewed critically.

Based on the study and post hoc analysis, the FDA granted EUA for the use of Bamlanivimab for non-hospitalized adults and children who have high risk to progress to severe COVID or hospitalization. Full details of the EUA can be read here, I encourage you to read at least the first eight pages.(4)

So what is our responsibility in utilizing this drug?

I think many of us can share the frustration with lack of treatment for patients at risk for severe COVID. In the ED we see many patients who are sick, but not quite sick enough yet to require hospitalization. Many of us are sending these patients home with guidance regarding pulse oximetry and parameters of when to return once they worsen. We have all seen patients presenting to the ED with mild COVID symptoms, but whom have significant risk factors, return 7-10 days later with severe COVID disease.  While this certainly is not a panacea for preventing severe COVID, these are the patient whom we should consider offering this treatment. This should be a risk and benefit discussion with each patient that meets EUA eligibility criteria. We should inform patients this is not yet considered standard of care, and it is still an experimental drug. 

I have about two weeks experience with this drug and have administered it personally around 10 times. Although the EUA authorizes use for those within 10 days of symptom onset, I have been attempting to target patients as early as possible. Ideally same day as diagnosis, or within five days. In the study, the median time from symptom onset to infusion was 4 days, so if we want to replicate any of the positive benefits of the drug, we need to capture patients early. In my opinion, patients presenting late in their course, day 8-10 may be less likely to benefit, and it may not outweigh the risks. In our ED we have been using rapid COVID antigen testing for those with symptoms 5 days or less, and if they have significant risk factors, we will offer immediate infusion in our ED overflow area.

This week, we also launched an outpatient infusion center in which PCPs may refer eligible patients for infusion. Myself, along with two other ED physicians are on call during business hours to secondarily screen patients for eligibility criteria. While certainly this shouldn’t be viewed as standard of care, I do feel we should at least consider this treatment to all members of our local community who meet criteria and may benefit.

Citations.

 

 

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