Evaluating Minority Patients With Actemra - EMPACTA

Dec 23, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Genentech
Date Published:
12/17/2020
Date Updated:
12/23/2020
Original Posted Date:
12/23/2020
References

Contribution To Literature:

The EMPACTA trial showed that tocilizumab was superior to placebo at improving outcomes in patients hospitalized with COVID-19 pneumonia.

Description:

The goal of the trial was to evaluate the anti-interleukin-6 receptor monoclonal antibody tocilizumab compared with placebo among minority patients hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19).

Study Design

  • Randomized
  • Parallel
  • Placebo

Patients hospitalized with SARS-CoV-2 infection were randomized to tocilizumab (n = 259) versus placebo (n = 129).

  • Total number of enrollees: 388
  • Duration of follow-up: 6 months
  • Mean patient age: 60 years
  • Percentage female: 40%

Inclusion criteria:

  • Patients ≥18 years of age
  • Hospitalized with SARS-CoV-2 infection
  • Blood oxygen level <94% on room air

Exclusion criteria:

  • Receiving continuous positive airway pressure or mechanical ventilation
  • Imminent progression to death

Principal Findings:

The primary outcome, death or mechanical ventilation at 28 days, occurred in 12.0% of the tocilizumab group compared with 19.3% of the placebo group (p = 0.04).

Secondary outcomes:

  • Median time to hospital discharge: 6 days in the tocilizumab group compared with 7.5 days in the placebo group
  • All-cause mortality at 28 days: 10.4% of the tocilizumab group compared with 8.6% of the placebo group
  • Serious adverse events at 60 days: 15.2% of the tocilizumab group compared with 19.7% of the placebo group

Interpretation:

Among patients hospitalized with SARS-CoV-2 infection, tocilizumab was associated with a reduction in death or mechanical ventilation compared with placebo. There were no important safety concerns with tocilizumab. Tocilizumab was not associated with an improvement in survival.

References:

Salama C, Han J, Yau L, et al. Tocilizumab in Patients Hospitalized With Covid-19 Pneumonia. N Engl J Med 2020;Dec 17:[Epub ahead of print].

Clinical Topics: Cardiovascular Care Team, COVID-19 Hub, Prevention, Novel Agents

Keywords: Antibodies, Monoclonal, Humanized, Coronavirus, COVID-19, Minority Groups, Patient Discharge, Pneumonia, Primary Prevention, Receptors, Interleukin-6, Respiration, Artificial, severe acute respiratory syndrome coronavirus 2, Ventilation


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