Background. Published reports on tocilizumab inCOVID-19 pneumonitis show conflicting results due to weak designs or heterogeneity in critical methodological issues. Methods. This open-label trial, structured according to Simon’s optimal design, aims to identify factors predicting which patients could benefit from anti-IL6strategies and to enhance the design of unequivocal and reliable future randomized trials. A total of 46 patients with COVID-19 pneumonia needing of oxygen therapy to maintain SO2 > 93% and with recent worsening of lung function received a single infusionof tocilizumab. Clinical and biological markers were measured to test their predictive values. Primary endpoint was early and sustained clinical response.Results. Twenty-one patients fulfilled pre-defined response criteria. Lower levels of IL-6 at 24 h after tocilizumab infusion (P = 0.049) and higher base-line values of PaO2/FiO2 (P = 0.008) predicted a favourable response.Conclusions. Objective clinical response rate overcame the pre-defined threshold of 30%. Efficacy of tocilizumab to improve respiratory function inpatients selected according to our inclusion criteria warrants investigations in randomized trials.Keywords:
Tocilizumab in COVID-19 interstitial pneumonia
M Bonifazi;A Giacometti;S Menzo;L Zuccatosta;F Mei;S Svegliati;A Donati;M M D'Errico;M Pavani;A GabrielliUltimo
2021-01-01
Abstract
Background. Published reports on tocilizumab inCOVID-19 pneumonitis show conflicting results due to weak designs or heterogeneity in critical methodological issues. Methods. This open-label trial, structured according to Simon’s optimal design, aims to identify factors predicting which patients could benefit from anti-IL6strategies and to enhance the design of unequivocal and reliable future randomized trials. A total of 46 patients with COVID-19 pneumonia needing of oxygen therapy to maintain SO2 > 93% and with recent worsening of lung function received a single infusionof tocilizumab. Clinical and biological markers were measured to test their predictive values. Primary endpoint was early and sustained clinical response.Results. Twenty-one patients fulfilled pre-defined response criteria. Lower levels of IL-6 at 24 h after tocilizumab infusion (P = 0.049) and higher base-line values of PaO2/FiO2 (P = 0.008) predicted a favourable response.Conclusions. Objective clinical response rate overcame the pre-defined threshold of 30%. Efficacy of tocilizumab to improve respiratory function inpatients selected according to our inclusion criteria warrants investigations in randomized trials.Keywords:I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
