• Valentina Morena, Laura Milazzo, Letizia Oreni, Giovanna Bestetti, Tommaso Fossali, Cinzia Bassoli, Alessandro Torre, Maria Vittoria Cossu, Caterina Minari, Elisabetta Ballone, Andrea Perotti, Davide Mileto, Fosca Niero, Stefania Merli, Antonella Foschi, Stefania Vimercati, Giuliano Rizzardini, Salvatore Sollima, Lucia Bradanini, Laura Galimberti, Riccardo Colombo, Valeria Micheli, Cristina Negri, Anna Lisa Ridolfo, Luca Meroni, Massimo Galli, Spinello Antinori, and Mario Corbellino.
• Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.
• Eur. J. Intern. Med. 2020 Jun 1; 76: 364236-42.

BackgroundTocilizumab, a humanized monoclonal antibody, targets IL-6 receptors blocking downstream pro-inflammatory effects of IL-6. In preliminary reports it was suggested to be beneficial in patients with severe COVID-19.MethodsIn this open-label prospective study we describe clinical characteristics and outcome of 51 patients hospitalized with confirmed and severe COVID-19 pneumonia treated with tocilizumab intravenously. All patients had elevated IL-6 plasma level (>40 pg/mL) and oxygen saturation <93% in ambient air. Clinical outcomes, oxygen support, laboratory data and adverse events were collected over a follow-up of 30 days.ResultsForty-five patients (88%) were on high-flow oxygen supplementation, six of whom with invasive ventilation. From baseline to day 7 after tocilizumab we observed a dramatic drop of body temperature and CRP value with a significant increase in lymphocyte count (p<0.001). Over a median follow-up time of 34 days from tocilizumab, 34 patients (67%) showed an improvement in their clinical severity class; 31 were discharged; 17 (33%) showed a worsening of their clinical status, of these 14 died (27%). The mortality rate was significantly associated with mechanical ventilation at baseline (83.3% vs 20% of patients on non-invasive oxygen support; p=0.0001). The most frequent side effects were an increase of hepatic enzymes (29%), thrombocytopenia (14%), and serious bacterial and fungal infections (27%).ConclusionTocilizumab exerts a rapidly beneficial effect on fever and inflammatory markers, although no significant impact on the clinical outcome can be inferred by our results. Critically ill patients seem to have a high risk of serious infections with this drug.Copyright © 2020 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

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