Tocilizumab treatment for Cytokine Release Syndrome in hospitalized COVID-19 patients: survival and clinical outcomes
Main result
- 239 patients included, 44% (n=104) severe.
- No difference in age, gender, ethnicity or comorbidities between severe and non-severe patients (for all patients as well as the Tocilizumab-treated subgroup); however, severe patients with higher levels of utra-sensitive CRP (120 vs. 71, p=0.002), IL-6 and abnormal upper chest radiographs.
- 64% (n=153) received Tocilizumab: 90% of severe vs. 44% of non-severe (p<0.001) at 2 vs. 3 days post-admission (p<0.001); CRP at the time of administration was comparable in severe and non-severe patients (137.75 vs. 131.9, p=034).
- Patient survival (overall): overall 86%, severe 78% vs. non-severe 93% (p<0.001), ventilated (n=53) 72%.
- Survival of patients treated with Tocilizumab: overall 87%, severe 83% vs. non-severe 91% (non-significant difference), ventilated (n=48) 75%.
- Post-admission adverse events Tocilizumab: neutropenia (n=6, with 2 already present prior to injection), bacteremia (n=4, none associated with neutropenia and any occurring more than 10 days after injection), increased transaminases (n=?, no grade 4 hepatotoxicity).
- post-hoc analysis: significantly lower survival rate for whites compared to blacks or Hispanics
Takeaways
14-day survival of patients treated with Tocilizumab: overall 87%, severe cases 83% vs. non-severe 91% (difference not significant), patients ventilated (n=48) 75%.
These survival rates may be overestimated (data not obtained in 66% of patients discharged from hospital, all were considered as survivors).
Strength of evidence Weak
- Retrospective descriptive observational chart review, monocentric
- Pre-proof
Objectives
Method
- Inclusion of COVID-19 (PCR diagnosis) patients over 18 years of age admitted consecutively to a hospital centre from March 10 to 31, 2020.
- Severity: classification of severity corresponding to the severity at admission.
- Algorithm applied for the administration of Tocilizumab: immediate administration if infection is severe (defined by an oxygen requirement ≥3L/min to maintain an SpO2 >93%) or critical (need for mechanical ventilation); administration in case of suspicion of a cytokine storm starting in non-severe patients (increase in ultra-sensitive CRP and/or oxygen therapy flow). Tocilizumab was injected IV at a dose of 8mg/kg, not exceeding 800mg, although a second dose could be administered in case of high BMI (no threshold specified).
- Primary endpoint: 14-day survival; secondary endpoint: number of days on mechanical ventilation and post-Tocilizumab response to cytokine storm.
- Predefined subgroup analyses for those receiving Tocilizumab and those requiring mechanical ventilation. Post hoc analysis of black and Hispanic ethnic subgroups.
- Estimated overall survival according to Kaplan-Meier; pre/post Tocilizumab comparisons according to McNemar for categorical variables, according to Wilcoxon for continuous variables; comparisons between severe and non-severe subgroups according to Chi2 for categorical variables, according to Wilcoxon for continuous variables.
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