1. Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
- Author
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Campochiaro C., Della-Torre E., Cavalli G., De Luca G., Ripa M., Boffini N., Tomelleri A., Baldissera E., Rovere-Querini P., Ruggeri A., Monti G., De Cobelli F., Zangrillo A., Tresoldi M., Castagna A., Dagna L (TOCI-RAF Study Group), Landoni G, DELLA TORRE , EMANUEL, Campochiaro, C., Della-Torre, E., Cavalli, G., De Luca, G., Ripa, M., Boffini, N., Tomelleri, A., Baldissera, E., Rovere-Querini, P., Ruggeri, A., Monti, G., De Cobelli, F., Zangrillo, A., Tresoldi, M., Castagna, A., Dagna, L (TOCI-RAF Study Group), Landoni, G, and DELLA TORRE, Emanuel
- Subjects
Male ,musculoskeletal diseases ,medicine.medical_specialty ,Multivariate analysis ,Coronavirus disease 2019 (COVID-19) ,Efficacy ,Pneumonia, Viral ,macromolecular substances ,030204 cardiovascular system & hematology ,Antibodies, Monoclonal, Humanized ,Antiviral Agents ,Article ,Betacoronavirus ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Tocilizumab ,Medical microbiology ,Internal medicine ,Intensive care ,Internal Medicine ,Humans ,Medicine ,030212 general & internal medicine ,skin and connective tissue diseases ,Pandemics ,Aged ,Retrospective Studies ,business.industry ,Interleukin-6 ,Standard treatment ,Oxygen Inhalation Therapy ,COVID-19 ,Retrospective cohort study ,Middle Aged ,Receptors, Interleukin-6 ,Coronavirus ,Outcome and Process Assessment, Health Care ,chemistry ,Italy ,Cohort ,Female ,Safety ,Coronavirus Infections ,Respiratory Insufficiency ,business - Abstract
Highlight • This is the first study comparing tocilizumab to standard of care in severe COVID-19 • Tocilizumab in severe COVID-19 patients did influence 28-day clinical outcomes • Tocilizumab safety was safisfactory except for ICU-admitted patients, Background : Tocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, has been proposed for the treatment of COVID-19 patients; however, limited data are available on the safety and efficacy. Methods : We performed a retrospective study on severe COVID-19 patients with hyper-inflammatory features admitted outside intensive care units (ICUs). Patients treated with intravenous TCZ in addition to standard of care were compared to patients treated with standard of care alone. Safety and efficacy were assessed over a 28-day follow-up. Results : 65 patients were included, 32 were of whose treated with TCZ. At baseline, all patients were on high-flow supplemental oxygen and most (78% of TCZ patients and 61% of standard treatment patients) were on non-invasive ventilation. During the 28-day follow-up, 69% of TCZ patients experienced a clinical improvement compared to 61% of standard treatment patients (p = 0.61). Mortality was 15% in the tocilizumab group and 33% in standard treatment group (p = 0.15). In TCZ group, at multivariate analysis, older age was a predictor of death, whereas higher baseline PaO2:FiO2 was a predictor of clinical improvement at day 28. The rate of infection and pulmonary thrombosis was similar between the two groups. Conclusions : At day 28, clinical improvement and mortality were not statistically significant different between tocilizumab and standard treatment patients in our cohort. Bacterial or fungal infections were recorded in 13% of tocilizumab patients and in 12% of standard treatment patients. Confirmation of efficacy and safety will require ongoing controlled trials.
- Published
- 2020