• Alessia Ferrarini, Angelo Vacca, Antonio Giovanni Solimando, Marcello Tavio, Rossella Acquaviva, Marco Rocchi, Cinzia Nitti, Aldo Salvi, Vincenzo Menditto, Michele Maria Luchetti Gentiloni, Alessandro Russo, Marco Moretti, Marianna Pavani, Andrea Giacometti, Martina Bonifazi, Lina Zuccatosta, Laura Romani, Vito Racanelli, Gianluca Moroncini, Armando Gabrielli, and Giovanni Pomponio.
• Clinica Medica, Ospedali Riuniti di Ancona, Ancona, Italy.
• Eur. J. Clin. Invest. 2023 Feb 1; 53 (2): e13898e13898.

BackgroundControversies on sub-populations most sensitive to therapy and the best timing of starting the treatment still surround the use of immunomodulatory drugs in COVID-19.ObjectivesWe designed a multicentre open-label randomised controlled trial to test the effect of prompt adding of tofacitinib to standard therapy for hospitalised patients affected by mild/moderate COVID-19 pneumonitis.MethodsPatients admitted to three Italian hospitals affected by COVID-19 pneumonitis not requiring mechanical ventilation were randomised to receive standard treatment alone or tofacitinib (10 mg/bid) for 2 weeks, starting within the first 24 h from admission.ResultsA total of 116 patients were randomised; 49 in the experimental arm completed the 14-day treatment period, 9 discontinued tofacitinib as the disease worsened and were included in the analysis, and 1 died of respiratory failure. All 58 control patients completed the study. Clinical and demographic characteristics were similar between the study groups. In the tofacitinib group, 9/58 (15.5%) patients progressed to noninvasive ventilation (CPAP) to maintain SO2  > 93%, invasive mechanical ventilation or death by day 14 was 15.5%, significantly less than in the control group (20/58, 34.4%, RR 0,45, RRR -55%, NNT 5; p = .018). No differences in severe adverse effect incidence had been observed across the groups.ConclusionHigh-dose tofacitinib therapy in patients with COVID pneumonitis is safe and may prevent deterioration to respiratory failure.© 2022 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.

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