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 / Pomponio, G; Ferrarini, A; Bonifazi, M; Moretti, M; Salvi, A; Giacometti, A; Tavio, M; Titolo, G; Morbidoni, L; Frausini, G; Onesta, M; Amico, D; B Rocchi, M L; Menzo, S; Zuccatosta, L; Mei, F; Menditto, V; Svegliati, S; Donati, A; M D'Errico, M; Pavani, M; Gabrielli, A. - In: JOURNAL OF INTERNAL MEDICINE. - ISSN 0954-6820. - ELETTRONICO. - 289:5(2021), pp. 738-746. [10.1111/joim.13231]
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.
