Compassionate use of JAK1/2 inhibitor ruxolitinib for severe COVID-19: a prospective observational study
Author:
Vannucchi Alessandro M.ORCID, Sordi Benedetta, Morettini AlessandroORCID, Nozzoli Carlo, Poggesi Loredana, Pieralli Filippo, Bartoloni Alessandro, Atanasio Alessandro, Miselli FilippoORCID, Paoli Chiara, Loscocco Giuseppe G.ORCID, Fanelli Andrea, Para Ombretta, Berni Andrea, Tassinari Irene, Zammarchi Lorenzo, Maggi Laura, Mazzoni Alessio, Scotti Valentina, Falchetti Giorgia, Malandrino DaniloORCID, Luise Fabio, Millotti Giovanni, Bencini Sara, Capone Manuela, Piccinni Marie Pierre, Annunziato Francesco, Guglielmelli PaolaORCID, Mannelli Francesco, Coltro Giacomo, Fantoni Duccio, Borella Miriam, Ravenda Enrica, Peruzzi Benedetta, Caporale Roberto, Cosmi Lorenzo, Liotta Francesco, Lombardelli Letizia, Logiodice Federica, Vanni Anna, Salvati Lorenzo, Lazzeri Chiara, Bonizzoli Manuela, Peris Adriano, Cianchi Giovanni, Bosi Alberto, Pucatti Michela, Fontanari Paolo, Benemei Silvia, Matucci Cerinic Marco, Turco Lucia,
Abstract
AbstractOverwhelming inflammatory reactions contribute to respiratory distress in patients with COVID-19. Ruxolitinib is a JAK1/JAK2 inhibitor with potent anti-inflammatory properties. We report on a prospective, observational study in 34 patients with COVID-19 who received ruxolitinib on a compassionate-use protocol. Patients had severe pulmonary disease defined by pulmonary infiltrates on imaging and an oxygen saturation ≤ 93% in air and/or PaO2/FiO2 ratio ≤ 300 mmHg. Median age was 80.5 years, and 85.3% had ≥ 2 comorbidities. Median exposure time to ruxolitinib was 13 days, median dose intensity was 20 mg/day. Overall survival by day 28 was 94.1%. Cumulative incidence of clinical improvement of ≥2 points in the ordinal scale was 82.4% (95% confidence interval, 71–93). Clinical improvement was not affected by low-flow versus high-flow oxygen support but was less frequent in patients with PaO2/FiO2 < 200 mmHg. The most frequent adverse events were anemia, urinary tract infections, and thrombocytopenia. Improvement of inflammatory cytokine profile and activated lymphocyte subsets was observed at day 14. In this prospective cohort of aged and high-risk comorbidity patients with severe COVID-19, compassionate-use ruxolitinib was safe and was associated with improvement of pulmonary function and discharge home in 85.3%. Controlled clinical trials are necessary to establish efficacy of ruxolitinib in COVID-19.
Publisher
Springer Science and Business Media LLC
Subject
Oncology,Cancer Research,Hematology
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