David A Nace MD MPH CMD Associate Professor of Medicine Clinical Chief Division of Geriatric Medicine University of Pittsburgh December 17 2020 Speaker Disclosures Dr Nace has no relevant financial disclosures ID: 928608
Download Presentation The PPT/PDF document "Using Monoclonal Antibodies in LTC" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
Using Monoclonal Antibodies in LTC
David A. Nace, MD, MPH, CMDAssociate Professor of MedicineClinical ChiefDivision of Geriatric MedicineUniversity of Pittsburgh
December 17, 2020
Slide2Speaker DisclosuresDr Nace has no relevant financial disclosures.
Slide3Goals of this presentation are to answer:
What are monoclonal antibodies?Why use monoclonal antibodies?Who are candidates for monoclonal antibodies?What do I need to do when prescribing?Can we provide this treatment in post-acute & LTC settings?
Slide4COVID-19
COVID-19 is the disease caused by the SARS-CoV-2 virus
Human Cell
SARS-CoV-2 Virus
Slide5Monoclonal Antibodies
MAB block binding of the spike protein to the receptor
MAB = monoclonal antibody
Slide6Why Use Monoclonal Antibodies?
The FDA granted emergency use authorization for use for two MAB products in November 2020.Bamlanivimab (Eli Lilly)Casirivimab and imdevimab (Regeneron)*We are going to focus only on MAB use in adults during this presentation
Indicated for the Treatment of:
Adults or children* with mild-moderate COVID-19
With positive test results for SARS-CoV-2 virus
(PCR or antigen)
Who are
at risk
for progressing to severe COVID-19 or hospitalization
Within 10 days of symptom onset
Slide7What are the Benefits?
*Early analysis of data from ongoing Phase 1 and Phase 2 studies
Slide8Hospitalizations/ED Visits w/i 28 Days
Bamlanivimab1Bamlanivimab2.0%
Placebo10%
Absolute Difference8.0%Number Needed to Treat to Avoid 1 Hospitalization/ED Visit12.5
Casirivimab and Imdevimab
2
Casirivimab /
Imdevimab
2.9%
Placebo
9.0%
Absolute Difference
6.1%
Number Needed to Treat to Avoid 1 Hospitalization/ED Visit
16.4
1=for single dose of 700 mg
2=for single dose of 2400 mg
https://www.fda.gov/media/144468/download
https://www.fda.gov/media/144118/download
Slide9Who Should Not Receive Monoclonal Antibodies?
Individuals who are
hospitalized
due to COVID-19
Individuals who require oxygen therapy due to COVID-19
Individuals who require an
increase in baseline oxygen
flow due to COVID-19 in those on chronic oxygen therapy due to underlying health conditions
Slide10Who Is High Risk?
Are ≥65 years of ageAre ≥55 years of age AND have cardiovascular disease, ORhypertension, OR chronic obstructive pulmonary disease/other chronic respiratory diseaseBody mass index (BMI) ≥35 Chronic kidney disease Diabetes Immunosuppression due to disease or treatment
Slide11Side Effects
Most CommonNauseaDiarrheaDizzinessHeadache
Pruritus
Vomiting
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs
Side effects rates were similar in both the placebo and control groups
1 case of anaphylaxis in the
bamlanivimab
group
Slide12Administration
IV infusionMix in 0.9% salineInfuse over a minimum of 60 minutesCan infuse with or without a pumpUse a filtered line
Slide13Clinicians Responsibilities
Explain the FDA has authorized emergency use of the MAB in test positive, mild to moderate illness, at risk individualsProvide education on risks, benefits, and alternative treatments (see fact sheet for patients)Confirm the person should still adhere to self-isolation, wear a mask, hand hygiene and cleaning of high-touch surfaces.Report serious adverse events & med errors within 7 calendar days (see fact sheet for healthcare providers)
Slide14https://www.fda.gov/media/143892/downloadhttps://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs
Documents Can Be Found At:
Slide15https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs
Slide16Can We Use These in PALTC Settings?
YesFDA authorized – which means they are a recognized medical treatmentInvestigational – which means there are ongoing studies to learn moreNot experimental – they are not being administered as part of a clinical trial11
28 PA Code. §
201.29 http://www.pacodeandbulletin.gov/Display/pacode?file=/secure/pacode/data/028/chapter201/s201.29.html&d=reduce
(last accessed December 5, 2020)
Slide17Thank You!
Contact Information
David A. Nace, MD, MPH, CMD
naceda@upmc.edu
Questions?