Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19
Results from the BLAZE-1 RCT of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment.
NCT04427501 (history).
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, VanBlargan].
risk of death, 94.7% lower, RR 0.05, p = 0.002, treatment 0 of 518 (0.0%), control 9 of 517 (1.7%), NNT 57, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), COVID-19 deaths.
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risk of death/hospitalization, 69.5% lower, RR 0.30, p < 0.001, treatment 11 of 518 (2.1%), control 36 of 517 (7.0%), NNT 21, primary outcome.
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recovery time, 11.1% lower, relative time 0.89, p = 0.007, treatment 518, control 517, sustained resolution of symptoms.
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risk of no viral clearance, 66.6% lower, RR 0.33, p < 0.001, treatment 50 of 508 (9.8%), control 147 of 499 (29.5%), NNT 5.1, day 7, persistently high viral load.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Dougan et al., 7 Oct 2021, Double Blind Randomized Controlled Trial, USA, peer-reviewed, 33 authors, average treatment delay 4.0 days, trial
NCT04427501 (history).
Abstract: T h e n e w e ng l a n d j o u r na l o f m e dic i n e
Original Article
Bamlanivimab plus Etesevimab in Mild
or Moderate Covid-19
M. Dougan, A. Nirula, M. Azizad, B. Mocherla, R.L. Gottlieb, P. Chen, C. Hebert,
R. Perry, J. Boscia, B. Heller, J. Morris, C. Crystal, A. Igbinadolor, G. Huhn,
J. Cardona, I. Shawa, P. Kumar, A.C. Adams, J. Van Naarden, K.L. Custer,
M. Durante, G. Oakley, A.E. Schade, T.R. Holzer, P.J. Ebert, R.E. Higgs,
N.L. Kallewaard, J. Sabo, D.R. Patel, M.C. Dabora, P. Klekotka, L. Shen,
and D.M. Skovronsky, for the BLAZE-1 Investigators*
A BS T R AC T
BACKGROUND
The authors’ full names, academic degrees, and affiliations are listed in the
Appendix. Address reprint requests to
Dr. Skovronsky at Eli Lilly, 893 Delaware
St., Indianapolis, IN 46225, or at skovronsky
_daniel@lilly.com.
*A list of the BLAZE-1 investigators is
provided in the Supplementary Appendix, available at NEJM.org.
Drs. Dougan and Nirula contributed equally to this article.
This article was published on July 14,
2021, at NEJM.org.
N Engl J Med 2021;385:1382-92.
DOI: 10.1056/NEJMoa2102685
Copyright © 2021 Massachusetts Medical Society.
CME
at NEJM.org
Patients with underlying medical conditions are at increased risk for severe coronavirus disease 2019 (Covid-19). Whereas vaccine-derived immunity develops over
time, neutralizing monoclonal-antibody treatment provides immediate, passive
immunity and may limit disease progression and complications.
METHODS
In this phase 3 trial, we randomly assigned, in a 1:1 ratio, a cohort of ambulatory
patients with mild or moderate Covid-19 who were at high risk for progression to
severe disease to receive a single intravenous infusion of either a neutralizing
monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg
of etesevimab, administered together) or placebo within 3 days after a laboratory
diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The primary outcome was the overall clinical status of the patients, defined
as Covid-19–related hospitalization or death from any cause by day 29.
RESULTS
A total of 1035 patients underwent randomization and received an infusion of
bamlanivimab–etesevimab or placebo. The mean (±SD) age of the patients was
53.8±16.8 years, and 52.0% were adolescent girls or women. By day 29, a total of
11 of 518 patients (2.1%) in the bamlanivimab–etesevimab group had a Covid-19–
related hospitalization or death from any cause, as compared with 36 of 517 patients (7.0%) in the placebo group (absolute risk difference, −4.8 percentage
points; 95% confidence interval [CI], −7.4 to −2.3; relative risk difference, 70%;
P<0.001). No deaths occurred in the bamlanivimab–etesevimab group; in the placebo group, 10 deaths occurred, 9 of which were designated by the trial investigators as Covid-19–related. At day 7, a greater reduction from baseline in the log
viral load was observed among patients who received bamlanivimab plus etesevimab than among those who received placebo (difference from placebo in the
change from baseline, −1.20; 95% CI, −1.46 to −0.94; P<0.001).
CONCLUSIONS
Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a
lower incidence of Covid-19–related hospitalization and death than did placebo
and accelerated the decline in the SARS-CoV-2 viral load. (Funded by Eli Lilly;
BLAZE-1 ClinicalTrials.gov number, NCT04427501.)
1382
n engl j med 385;15
nejm.org
October 7, 2021
The New England Journal..
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