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Observational Study
. 2021 Mar:104:433-440.
doi: 10.1016/j.ijid.2020.12.073. Epub 2020 Dec 29.

Canakinumab as treatment for COVID-19-related pneumonia: A prospective case-control study

Daniele Generali  1 , Giancarlo Bosio  2 , Fabio Malberti  3 , Antonio Cuzzoli  2 , Sophie Testa  4 , Laura Romanini  5 , Antonio Fioravanti  3 , Alessandro Morandini  3 , Luca Pianta  3 , Guglielmo Giannotti  3 , Erika Maria Viola  3 , Matteo Giorgi-Pierfranceschi  3 , Marina Foramitti  3 , Rosa Angela Tira  5 , Ilaria Zangrandi  5 , Giulia Chiodelli  6 , Andrea Machiavelli  6 , Maria Rosa Cappelletti  4 , Alessia Giossi  3 , Valeria De Giuli  3 , Chiara Costanzi  3 , Chiara Campana  3 , Ottavia Bernocchi  2 , Marianna Sirico  3 , Alessia Zoncada  3 , Alfredo Molteni  3 , Sergio Venturini  7 , Fabiola Giudici  8 , Maurizio Scaltriti  9 , Angelo Pan  3
Affiliations
Free PMC article
Observational Study

Canakinumab as treatment for COVID-19-related pneumonia: A prospective case-control study

Daniele Generali et al. Int J Infect Dis. 2021 Mar.
Free PMC article

Abstract

Objectives: Canakinumab is an IL-1β antibody that neutralises the activity of IL-1β. 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.

Keywords: COVID-19; Canakinumab; Pneumonia; SARS-CoV-2.

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Figures

Figure 1
Figure 1
Changes in lung damage before ((A) Diffuse ground glass opacities with peripheral nodular consolidation) and after administration ((B) Less peripheral ground glass opacities) of canakinumab.
Figure 2
Figure 2
(a) Changes over time in immune response-related markers: comparison between Cohort 1 and Cohort 2 (T0: basal; T1 after first administration of canakinumab; T2 after 7–10 days from the second administration of canakinumab). The N/L ratio is also reported. (b) Changes over time in immune-inflammatory-related biomarkers: comparison between Cohort 1 and Cohort 2.
Figure 3
Figure 3
(a) Overall survival in Cohort 1 and Cohort 2. (b) Cumulative incidence of clinical improvement from hospital admission to hospital discharge.
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