Background: Controversies 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. Objectives: We 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. Methods: Patients 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. Results: A 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. Conclusion: High-dose tofacitinib therapy in patients with COVID pneumonitis is safe and may prevent deterioration to respiratory failure.

Early administration of tofacitinib in COVID-19 pneumonitis: An open randomised controlled trial / Ferrarini, Alessia; Vacca, Angelo; Solimando, Antonio Giovanni; Tavio, Marcello; Acquaviva, Rossella; Rocchi, Marco; Nitti, Cinzia; Salvi, Aldo; Menditto, Vincenzo; Luchetti Gentiloni, Michele Maria; Russo, Alessandro; Moretti, Marco; Pavani, Marianna; Giacometti, Andrea; Bonifazi, Martina; Zuccatosta, Lina; Romani, Laura; Racanelli, Vito; Moroncini, Gianluca; Gabrielli, Armando; Pomponio, Giovanni. - In: EUROPEAN JOURNAL OF CLINICAL INVESTIGATION. - ISSN 0014-2972. - 53:2(2023), p. e13898. [10.1111/eci.13898]

Early administration of tofacitinib in COVID-19 pneumonitis: An open randomised controlled trial

Ferrarini, Alessia;Tavio, Marcello;Nitti, Cinzia;Salvi, Aldo;Menditto, Vincenzo;Luchetti Gentiloni, Michele Maria;Pavani, Marianna;Giacometti, Andrea;Bonifazi, Martina;Zuccatosta, Lina;Romani, Laura;Moroncini, Gianluca;Gabrielli, Armando;Pomponio, Giovanni
2023-01-01

Abstract

Background: Controversies 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. Objectives: We 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. Methods: Patients 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. Results: A 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. Conclusion: High-dose tofacitinib therapy in patients with COVID pneumonitis is safe and may prevent deterioration to respiratory failure.
2023
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11566/315021
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