Tocilizumab for Treatment of Severe COVID-19 Patients: Preliminary Results from SMAtteo COvid19 REgistry (SMACORE)
Top Cited Papers
Open Access
- 8 May 2020
- journal article
- research article
- Published by MDPI AG in Microorganisms
- Vol. 8 (5), 695
- https://doi.org/10.3390/microorganisms8050695
Abstract
Objective: This study aimed to assess the role of Tocilizumab therapy (TCZ) in terms of ICU admission and mortality rate of critically ill patients with severe COVID-19 pneumonia. Design: Patients with COVID-19 pneumonia were prospectively enrolled in SMAtteo COvid19 REgistry (SMACORE). A retrospective analysis of patients treated with TCZ matched using propensity score to patients treated with Standard Of Care (SOC) was conducted. Setting: The study was conducted at IRCCS Policlinico San Matteo Hospital, Pavia, Italy, from March 14, 2020 to March 27, 2020. Participants: Patients with a confirmed diagnosis of COVID-19 hospitalized in our institution at the time of TCZ availability. Interventions: TCZ was administered to 21 patients. The first administration was 8 mg/kg (up to a maximum 800 mg per dose) of Tocilizumab intravenously, repeated after 12 h if no side effects were reported after the first dose. Main Outcomes and Measures: ICU admission and 7-day mortality rate. Secondary outcomes included clinical and laboratory data. Results: There were 112 patients evaluated (82 were male and 30 were female, with a median age of 63.55 years). Using propensity scores, the 21 patients who received TCZ were matched to 21 patients who received SOC (a combination of hydroxychloroquine, azithromycin and prophylactic dose of low weight heparin). No adverse event was detected following TCZ administration. This study found that treatment with TCZ did not significantly affect ICU admission (OR 0.11; 95% CI between 0.00 and 3.38; p = 0.22) or 7-day mortality rate (OR 0.78; 95% CI between 0.06 and 9.34; p = 0.84) when compared with SOC. Analysis of laboratory measures showed significant interactions between time and treatment regarding C-Reactive Protein (CRP), alanine aminotransferase (ALT), platelets and international normalized ratio (INR) levels. Variation in lymphocytes count was observed over time, irrespective of treatment. Conclusions: TCZ administration did not reduce ICU admission or mortality rate in a cohort of 21 patients. Additional data are needed to understand the effect(s) of TCZ in treating patients diagnosed with COVID-19.This publication has 38 references indexed in Scilit:
- Corticosteroids for treating sepsisCochrane Database of Systematic Reviews, 2015
- Fitting Linear Mixed-Effects Models Usinglme4Journal of Statistical Software, 2015
- Hemophagocytic LymphohistiocytosisAmerican Journal of Clinical Pathology, 2013
- Blocking the effects of interleukin-6 in rheumatoid arthritis and other inflammatory rheumatic diseases: systematic literature review and meta-analysis informing a consensus statementAnnals Of The Rheumatic Diseases, 2012
- An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational StudiesMultivariate Behavioral Research, 2011
- A Tutorial and Case Study in Propensity Score Analysis: An Application to Estimating the Effect of In-Hospital Smoking Cessation Counseling on MortalityMultivariate Behavioral Research, 2011
- mice: Multivariate Imputation by Chained Equations inRJournal of Statistical Software, 2011
- Masked early symptoms of pneumonia in patients with rheumatoid arthritis during tocilizumab treatment: a report of two casesModern Rheumatology, 2009
- Masked early symptoms of pneumonia in patients with rheumatoid arthritis during tocilizumab treatment: a report of two casesModern Rheumatology, 2008
- Cytokine Balance in the Lungs of Patients with Acute Respiratory Distress SyndromeAmerican Journal of Respiratory and Critical Care Medicine, 2001