• G Pomponio, A Ferrarini, M Bonifazi, M Moretti, A Salvi, A Giacometti, M Tavio, G Titolo, L Morbidoni, G Frausini, M Onesta, D Amico, M L B Rocchi, S Menzo, L Zuccatosta, F Mei, V Menditto, S Svegliati, A Donati, M M D'Errico, M Pavani, and A Gabrielli.
• From the, Clinica Medica, Ospedali Riuniti di Ancona, Ancona, Italy.
• J. Intern. Med. 2021 May 1; 289 (5): 738-746.

BackgroundPublished reports on tocilizumab in COVID-19 pneumonitis show conflicting results due to weak designs or heterogeneity in critical methodological issues.MethodsThis open-label trial, structured according to Simon's optimal design, aims to identify factors predicting which patients could benefit from anti-IL6 strategies 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 infusion of tocilizumab. Clinical and biological markers were measured to test their predictive values. Primary end point was early and sustained clinical response.ResultsTwenty-one patients fulfilled pre-defined response criteria. Lower levels of IL-6 at 24 h after tocilizumab infusion (P = 0.049) and higher baseline values of PaO2/FiO2 (P = 0.008) predicted a favourable response.ConclusionsObjective clinical response rate overcame the pre-defined threshold of 30%. Efficacy of tocilizumab to improve respiratory function in patients selected according to our inclusion criteria warrants investigations in randomized trials.© 2020 The Association for the Publication of the Journal of Internal Medicine.

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