Objectives: Canakinumab is an IL-1? antibody that neutralises the activity of IL-1?. This study examined the efficacy and safety of canakinumab in patients with moderate COVID-19-related pneumonia. Design: This study aimed to evaluate the reduction in duration of hospitalisation with adequate oxygen status. Forty-eight patients with moderate COVID-19-related pneumonia were asked to participate in the prospective case-control study: 33 patients (cases) signed informed consent and received canakinumab (Cohort 1) and 15 patients (Controls) refused to receive the experimental drug and received institutional standard of care (Cohort 2). Results: Hospital discharge within 21 days was seen in 63% of patients in Cohort 1 vs. 0% in Cohort 2 (median 14 vs. 26 days, respectively; p < 0.001). There was significant clinical improvement in ventilation regimes following administration of canakinumab compared with Cohort 2 (Stuart-Maxwell test for paired data, p < 0.001). Patients treated with canakinumab experienced a significant increase in PaO2: FiO2 (p < 0.001) and reduction in lung damage by CT (p = 0.01), along with significant decreases in immune/inflammation markers that were not observed in Cohort 2. Only mild side-effects were seen in patients treated with canakinumab; survival at 60 days was 90.0% (95% CI 71.9?96.7) in patients treated with canakinumab and 73.3% (95% CI 43.6?89.1) for Cohort 2. Conclusions: Treatment with canakinumab in patients with COVID-19-related pneumonia rapidly restored normal oxygen status, decreased the need for invasive mechanical ventilation, and was associated with earlier hospital discharge and favourable prognosis versus standard of care. ? 2021 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc
Generali, D., Bosio, G., Malberti, F., Cuzzoli, A., Testa, S., Romanini, L., Fioravanti, A., Morandini, P. A., Pianta, L., Giannotti, G., Viola, E. M., Giorgi-Pierfranceschi, M., Foramitti, M., Tira, R. A., Zangrandi, I., Chiodelli, G., Machiavelli, A., Cappelletti, M. R., Giossi, A., De Giuli, V., Costanzi, C., Campana, C., Bernocchi, O., Sirico, M., Zoncada, A., Molteni, A., Venturini, S., Giudici, F., Scaltriti, M., Pan, A., Canakinumab as treatment for COVID-19-related pneumonia: A prospective case-control study, <<INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES>>, 2021; 104 (N/A): 433-440. [doi:10.1016/j.ijid.2020.12.073] [https://hdl.handle.net/10807/238858]
Canakinumab as treatment for COVID-19-related pneumonia: A prospective case-control study
Generali, Daniele
Primo
;Bosio, Giacomo;Morandini, Piero Angelo;Chiodelli, Giulia;Costanzi, Carla;Venturini, Sergio;
2021
Abstract
Objectives: Canakinumab is an IL-1? antibody that neutralises the activity of IL-1?. This study examined the efficacy and safety of canakinumab in patients with moderate COVID-19-related pneumonia. Design: This study aimed to evaluate the reduction in duration of hospitalisation with adequate oxygen status. Forty-eight patients with moderate COVID-19-related pneumonia were asked to participate in the prospective case-control study: 33 patients (cases) signed informed consent and received canakinumab (Cohort 1) and 15 patients (Controls) refused to receive the experimental drug and received institutional standard of care (Cohort 2). Results: Hospital discharge within 21 days was seen in 63% of patients in Cohort 1 vs. 0% in Cohort 2 (median 14 vs. 26 days, respectively; p < 0.001). There was significant clinical improvement in ventilation regimes following administration of canakinumab compared with Cohort 2 (Stuart-Maxwell test for paired data, p < 0.001). Patients treated with canakinumab experienced a significant increase in PaO2: FiO2 (p < 0.001) and reduction in lung damage by CT (p = 0.01), along with significant decreases in immune/inflammation markers that were not observed in Cohort 2. Only mild side-effects were seen in patients treated with canakinumab; survival at 60 days was 90.0% (95% CI 71.9?96.7) in patients treated with canakinumab and 73.3% (95% CI 43.6?89.1) for Cohort 2. Conclusions: Treatment with canakinumab in patients with COVID-19-related pneumonia rapidly restored normal oxygen status, decreased the need for invasive mechanical ventilation, and was associated with earlier hospital discharge and favourable prognosis versus standard of care. ? 2021 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-ncFile | Dimensione | Formato | |
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