ATTKPATRASCOVID19
Trial question
Is baricitinib noninferior to tocilizumab in patients with severe COVID-19 infection?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 251
251 patients (103 female, 148 male)
Inclusion criteria: patients with COVID-19 and the ratio of partial pressure of oxygen to FiO2 < 200
Key exclusion criteria: age < 18 years; pregnancy; eGFR < 30 mL/min/1.73 m²; mechanical ventilation prior to randomization
Interventions
N=125 baricitinib (at a dose of 4 mg/day for up to 14 days or until discharge)
N=125 tocilizumab (a single infusion of 8 mg/kg plus standard care)
Primary outcome
Rate of mechanical ventilation or death by day 28
39.2
44.4
44.4 %
33.3 %
22.2 %
11.1 %
0.0 %
Baricitinib
Tocilizumab
Difference not exceeding
nonferiority margin ✓
Difference not exceeding nonferiority margin in the rate of mechanical ventilation or death by day 28 (39.2% vs. 44.4%; HR 0.83, 95% CI 0.56 to 1.21)
Secondary outcomes
Significant increase in the proportion of patients who were discharged alive after 28 days (58.4% vs. 52.4%; HR 1.17, 95% CI 0.84 to 1.63)
Borderline significant increase in risk of disease progression by day 10, as assessed by the WHO scale (0 vs. 0 ; )
Significant decrease in the rate of death within 28 days (32% vs. 39.7%; HR 0.73, 95% CI 0.49 to 1.09)
Safety outcomes
No significant difference in ≥ 1 adverse event.
Significant difference in increased liver transaminases (2.4% vs. 7.9%).
Conclusion
In patients with COVID-19 and the ratio of partial pressure of oxygen to FiO2 < 200, baricitinib was noninferior to tocilizumab with respect to the rate of mechanical ventilation or death by day 28.
Reference
Theodoros Karampitsakos, Ourania Papaioannou, Panagiota Tsiri et al. Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial. Clin Microbiol Infect. 2022 Oct 20;S1198-743X(22)00529-8.
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