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Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study.
Eur J Intern Med. 2020 06; 76:43-49.EJ

Abstract

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. Among them, 32 were 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 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.

Authors+Show Affiliations

Vita-Salute San Raffaele University, Milan, Italy; Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: campochiaro.corrado@hsr.it.Vita-Salute San Raffaele University, Milan, Italy; Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy.Vita-Salute San Raffaele University, Milan, Italy; Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy.Vita-Salute San Raffaele University, Milan, Italy; Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy.Vita-Salute San Raffaele University, Milan, Italy; Department of Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy.Vita-Salute San Raffaele University, Milan, Italy; Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy.Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy.Vita-Salute San Raffaele University, Milan, Italy; Internal Medicine, Diabetes & Endocrinology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.Hematology and Bone Marrow Transplant Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.Anesthesia and Intensive Care Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.Vita-Salute San Raffaele University, Milan, Italy; Radiology Department, IRCSS San Raffaele Scientific Institute, Milan, Italy.Vita-Salute San Raffaele University, Milan, Italy; Anesthesia and Intensive Care Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.General Medicine and Advanced Care Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.Vita-Salute San Raffaele University, Milan, Italy; Department of Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.Vita-Salute San Raffaele University, Milan, Italy; Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: lorenzo.dagna@unisr.it.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32482597

Citation

Campochiaro, Corrado, et al. "Efficacy and Safety of Tocilizumab in Severe COVID-19 Patients: a Single-centre Retrospective Cohort Study." European Journal of Internal Medicine, vol. 76, 2020, pp. 43-49.
Campochiaro C, Della-Torre E, Cavalli G, et al. Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study. Eur J Intern Med. 2020;76:43-49.
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. (2020). Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study. European Journal of Internal Medicine, 76, 43-49. https://doi.org/10.1016/j.ejim.2020.05.021
Campochiaro C, et al. Efficacy and Safety of Tocilizumab in Severe COVID-19 Patients: a Single-centre Retrospective Cohort Study. Eur J Intern Med. 2020;76:43-49. PubMed PMID: 32482597.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study. AU - Campochiaro,Corrado, AU - Della-Torre,Emanuel, AU - Cavalli,Giulio, AU - De Luca,Giacomo, AU - Ripa,Marco, AU - Boffini,Nicola, AU - Tomelleri,Alessandro, AU - Baldissera,Elena, AU - Rovere-Querini,Patrizia, AU - Ruggeri,Annalisa, AU - Monti,Giacomo, AU - De Cobelli,Francesco, AU - Zangrillo,Alberto, AU - Tresoldi,Moreno, AU - Castagna,Antonella, AU - Dagna,Lorenzo, AU - ,, Y1 - 2020/05/22/ PY - 2020/05/03/received PY - 2020/05/06/revised PY - 2020/05/07/accepted PY - 2020/6/3/pubmed PY - 2020/6/19/medline PY - 2020/6/3/entrez KW - COVID-19 KW - Coronavirus KW - Efficacy KW - Interleukin-6 KW - Italy KW - Safety KW - Tocilizumab SP - 43 EP - 49 JF - European journal of internal medicine JO - Eur J Intern Med VL - 76 N2 - 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. Among them, 32 were 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 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. SN - 1879-0828 UR - https://www.unboundmedicine.com/medline/citation/32482597/Efficacy_and_safety_of_tocilizumab_in_severe_COVID_19_patients:_a_single_centre_retrospective_cohort_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0953-6205(20)30199-0 DB - PRIME DP - Unbound Medicine ER -