Tofacitinib versus standard of care treatment in patients with COVID-19:
a multicenter non-randomized controlled study
This non-randomized controlled study aimed to assess the efficacy of
tofacitinib in reducing the risk of invasive mechanical ventilation or
death in patients with COVID-19. Patients with COVID-19 associated with
reduced oxygen saturation, increased C-reactive protein (≥50 mg/L),
and/or persisting fever were recruited. Tofacitinib was administered in
addition to standard of care therapy. Study outcomes were evaluated
separately in the groups of patients with oxygen saturation at rest
≤93% and >93%. Hazard ratios (HR) with 95% confidence
intervals (CI) were calculated using Cox regression analysis adjusted
for inverse propensity score weighting. Overall, 384 patients with
COVID-19 (212 males; median age 60 years) were included in our study and
were treated with tofactinib (n=131) or standard of care alone (n=253).
The percentages of patients who started mechanical ventilation or died
during hospitalization in the tofacitinib and control groups were 12.5%
(9/72) vs. 14.1% (26/185) among patients who required respiratory
support (HR 0.92, 95% CI 0.33-2.56), and 1.7% (1/59) vs. 4.4% (3/68)
in those with normal oxygen saturation (HR 0.83; 95 CI 0.07-9.44).
Tofacitinib did not reduce the risk of invasive mechanical ventilation
or death in patients with COVID-19, although the analysis of these
outcomes favored tofacitinib.