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Compassionate use of JAK1/2 inhibitor ruxolitinib for severe COVID-19: a prospective observational study.
Vannucchi, Alessandro M; Sordi, Benedetta; Morettini, Alessandro; Nozzoli, Carlo; Poggesi, Loredana; Pieralli, Filippo; Bartoloni, Alessandro; Atanasio, Alessandro; Miselli, Filippo; Paoli, Chiara; Loscocco, Giuseppe G; Fanelli, Andrea; Para, Ombretta; Berni, Andrea; Tassinari, Irene; Zammarchi, Lorenzo; Maggi, Laura; Mazzoni, Alessio; Scotti, Valentina; Falchetti, Giorgia; Malandrino, Danilo; Luise, Fabio; Millotti, Giovanni; Bencini, Sara; Capone, Manuela; Piccinni, Marie Pierre; Annunziato, Francesco; Guglielmelli, Paola.
  • Vannucchi AM; Center Research Innovation of Myeloproliferative Neoplasms (CRIMM), SOD Hematology, University of Florence and AOU Careggi, Florence, Italy. amvannucchi@unifi.it.
  • Sordi B; Center Research Innovation of Myeloproliferative Neoplasms (CRIMM), SOD Hematology, University of Florence and AOU Careggi, Florence, Italy.
  • Morettini A; Internal Medicine Unit 2, AOU Careggi, Florence, Italy.
  • Nozzoli C; Internal Medicine Unit 1, AOU Careggi, Florence, Italy.
  • Poggesi L; Internal Medicine Unit 3, AOU Careggi, Florence, Italy.
  • Pieralli F; Intermediate Care Unit COVID-19, AOU Careggi, Florence, Italy.
  • Bartoloni A; Infectious and Tropical Diseases Unit, AOU Careggi, Florence, Italy.
  • Atanasio A; Center Research Innovation of Myeloproliferative Neoplasms (CRIMM), SOD Hematology, University of Florence and AOU Careggi, Florence, Italy.
  • Miselli F; Center Research Innovation of Myeloproliferative Neoplasms (CRIMM), SOD Hematology, University of Florence and AOU Careggi, Florence, Italy.
  • Paoli C; Center Research Innovation of Myeloproliferative Neoplasms (CRIMM), SOD Hematology, University of Florence and AOU Careggi, Florence, Italy.
  • Loscocco GG; Center Research Innovation of Myeloproliferative Neoplasms (CRIMM), SOD Hematology, University of Florence and AOU Careggi, Florence, Italy.
  • Fanelli A; Internal Medicine Unit 2, AOU Careggi, Florence, Italy.
  • Para O; Internal Medicine Unit 1, AOU Careggi, Florence, Italy.
  • Berni A; Internal Medicine Unit 3, AOU Careggi, Florence, Italy.
  • Tassinari I; Intermediate Care Unit COVID-19, AOU Careggi, Florence, Italy.
  • Zammarchi L; Infectious and Tropical Diseases Unit, AOU Careggi, Florence, Italy.
  • Maggi L; Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.
  • Mazzoni A; Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.
  • Scotti V; Internal Medicine Unit 2, AOU Careggi, Florence, Italy.
  • Falchetti G; Internal Medicine Unit 2, AOU Careggi, Florence, Italy.
  • Malandrino D; Internal Medicine Unit 3, AOU Careggi, Florence, Italy.
  • Luise F; Intermediate Care Unit COVID-19, AOU Careggi, Florence, Italy.
  • Millotti G; Infectious and Tropical Diseases Unit, AOU Careggi, Florence, Italy.
  • Bencini S; Cytometry and Immunotherapy Diagnostic Center (CDCI), AOU Careggi, Florence, Italy.
  • Capone M; Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.
  • Piccinni MP; Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.
  • Annunziato F; Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.
  • Guglielmelli P; Cytometry and Immunotherapy Diagnostic Center (CDCI), AOU Careggi, Florence, Italy.
Leukemia ; 35(4): 1121-1133, 2021 04.
Article in English | MEDLINE | ID: covidwho-725732
ABSTRACT
Overwhelming 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Janus Kinase 1 / Janus Kinase 2 / Compassionate Use Trials / Janus Kinase Inhibitors / SARS-CoV-2 / COVID-19 / COVID-19 Drug Treatment Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: Leukemia Journal subject: Hematology / Neoplasms Year: 2021 Document Type: Article Affiliation country: S41375-020-01018-y

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Janus Kinase 1 / Janus Kinase 2 / Compassionate Use Trials / Janus Kinase Inhibitors / SARS-CoV-2 / COVID-19 / COVID-19 Drug Treatment Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: Leukemia Journal subject: Hematology / Neoplasms Year: 2021 Document Type: Article Affiliation country: S41375-020-01018-y