4CPS-036 Is our protocol for the use of tocilizumab in COVID patients adequate?

Abstract

Background and importanceTocilizumab (TCZ) has been a key pillar in the management of pulmonary hyperinflammation in patients with SARS-CoV-2 pneumonia. The incessant publication of new studies assessing its effectiveness and the ideal time of use means that in-hospital protocols are constantly being reviewed and updated.Aim and objectivesTo describe the clinical characteristics of hospitalised patients with SARS-CoV-2 pneumonia treated with TCZ and their evolution, and to compare our results with those of the primary endpoint (28-day mortality) of the RECOVERY study.Material and methodsRetrospective observational study of patients administered TCZ between October 2020 and February 2021 in a tertiary hospital. Criteria for TCZ use were PAFI <300 and meeting two of the following three criteria: C-reactive protein (CRP) >150 mg/L, D-dimer >1500 ng/mL and ferritin >2000 ng/mL, and not having contraindications for its use.Each patient received a single dose of 400 mg if weight <75 kg and 600 mg if weight >75 kg.Demographic data, comorbidities and days from symptom onset to TCZ administration were collected. Follow-up of analytical data (CRP, D-dimer and ferritin pre- and post- (15 days) TCZ administration). Clinical evolution was evaluated by mortality rate at 28 days.Statistical analysis: Stata/MP v16.0. Student’s t-test was used for comparison of quantitative variables.Results39 patients were included, 25 (64.1%) were male, median age 74 (IQR 61–80) years. 61.5% had hypertension, 33.3% obesity, 41% diabetes mellitus, 17.9% chronic kidney disease, 12.8% heart disease. The median time from symptom onset to TCZ administration was 10 (IQR 7–15) days.The medians prior to and at 15 days of TCZ administration were, respectively: 152.5 mg/L (IQR 89–220.8) and 1.7 mg/L (IQR 0.65–4.2) CRP (p<0.001);2300 ng/mL (IQR 11 959–4889) and 1124 ng/mL (IQR 567–1439) D-dimer (p=0.1726);1242 ng/mL (IQR 647–2705) and 851 ng/mL (IQR 268–1384) ferritin (p=0.1294). Mortality at 28 days was 64.1%.Conclusion and relevanceOur sample size is smaller than that of the RECOVERY study;however, the days of symptoms until TCZ administration (10 vs 9) and the median CRP prior to TCZ (143 vs 152.5 mg/L) in both studies are very similar. Our mortality is much higher (64.1% vs 29%). We found a statistically significant difference between our pre- and post-CRP data.With this result, the in-hospital protocol was modified and new criteria for TCZ administration in COVID patients became oxygen saturation <92% or PAFI >300 and CRP >75 mg/L, with no contraindications for use.In subsequent studies we will test whether this update helps to improve mortality outcomes.References and/or acknowledgementsConflict of interestNo conflict of interest