Tofacitinib in patients with COVID-19: a multicenter non-randomized controlled study

Moiseev S.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Bulanov N.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Zykova A.: Department of Internal Medicine, Lomonosov Moscow State University, Moscow, Russia

Brovko M.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Novikov P.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Akulkina L.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Chichkova N.: Vinogradov Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Trushenko N.: Clinic of Pulmonology and Respiratory Medicine, Sechenov First Moscow State Medical University, Moscow, Russia

Lukina M.: Department of Clinical Pharmacology and Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Sorokin Y.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Tao E.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Filatova E.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Kitbalyan A.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia. Department of Internal Medicine, Lomonosov Moscow State University, Moscow, Russia

Potapov P.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia. Department of Internal Medicine, Lomonosov Moscow State University, Moscow, Russia

Ermolova L.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Suvorova O.: Clinic of Pulmonology and Respiratory Medicine, Sechenov First Moscow State Medical University, Moscow, Russia

Avdeev S.: Clinic of Pulmonology and Respiratory Medicine, Sechenov First Moscow State Medical University, Moscow, Russia

Fomin V.: Vinogradov Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Download in PDF

Summary

Aim

To evaluate the efficacy of tofacitinib in addition to standard therapy versus standard treatment alone in reducing the risk of invasive mechanical ventilation or death in patients with COVID-19 pneumonia.

Material and methods

In a multicenter nonrandomised controlled trial, we recruited patients with bilateral COVID-19 pneumonia involving at least 25% of lung tissue and associated with reduced oxygen saturation, increased C-reactive protein (≥50 mg/L), and/or persisting fever. Tofacitinib was administered in addition to standard of care therapy. Comparators who received standard of care alone were selected randomly from the population of patients admitted to the three clinics of Sechenov University. Study end-points (death or requirement for mechanical ventilation) were evaluated separately in the cohorts 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.

Results

Overall, 384 patients with COVID-19 (212 males; median age 60 years) were enrolled in our study and were treated with tofactinib (n=131) or standard of care alone 29ОРИГИНАЛЬНЫЕ СТАТЬИ (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 0.079.44).

Conclusion

Tofacitinib in addition to standard of care therapy did not reduce the risk of invasive mechanical ventilation or death in patients with COVID-19, although the analysis of these outcomes favored JAK-inhibitor, particularly among patients with reduced SpO 2 treated with glucocorticoids.

Key words

COVID-19, JAK-inhibitors, tofacinib.