IL-1 Receptor Antagonist Anakinra in the Treatment of COVID-19 Acute Respiratory Distress Syndrome: A Retrospective, Observational Study.

Affiliation

Franzetti M(1), Forastieri A(2), Borsa N(3), Pandolfo A(4), Molteni C(4), Borghesi L(4), Pontiggia S(4), Evasi G(2), Guiotto L(2), Erba M(2), Pozzetti U(5), Ronchetti A(5), Valsecchi L(4), Castaldo G(4), Longoni E(4), Colombo D(3), Soncini M(5), Crespi S(6), Maggiolini S(7), Guzzon D(8), Piconi S(4).
Author information:
(1)Infectious Diseases Unit, Alessandro Manzoni Hospital, 23900 Lecco, Italy; [Email]
(2)Intensive Care Unit, Alessandro Manzoni Hospital, 23900 Lecco, Italy.
(3)Respiratory Unit, Scientific Institute for Research, Hospitalization, and Healthcare, Italian National Institutes of Health and Sciences on Ageing, c/o San Leopoldo Mandic Hospital, 23807 Merate, Italy.
(4)Infectious Diseases Unit, Alessandro Manzoni Hospital, 23900 Lecco, Italy.
(5)Medicine Department, Alessandro Manzoni Hospital, 23900 Lecco, Italy.
(6)Medicine Department, San Leopoldo Mandic Hospital, 23807 Merate, Italy.
(7)Cardiology Department, San Leopoldo Mandic Hospital, 23807 Merate, Italy; and.
(8)Intensive Care Unit, San Leopoldo Mandic Hospital, 23807 Merate, Italy.

Abstract

The IL-1 receptor antagonist, anakinra, may represent a therapeutic option for acute respiratory distress syndrome (ARDS) associated with coronavirus disease 2019 (COVID-19). In this study, COVID-19 ARDS patients admitted to the Azienda Socio Sanitaria Territoriale of Lecco, Italy, between March 5th to April 15th, 2020, and who had received anakinra off-label were retrospectively evaluated and compared with a cohort of matched controls who did not receive immunomodulatory treatment. The primary end point was survival at day 28. The population consisted of 112 patients (56 treated with anakinra and 56 controls). Survival at day 28 was obtained in 69 patients (61.6%) and was significantly higher in anakinra-treated patients than in the controls (75.0 versus 48.2%, p = 0.007). When stratified by continuous positive airway pressure support at baseline, anakinra-treated patients' survival was also significant compared with the controls (p = 0.008). Univariate analysis identified anakinra usage (odds ratio, 3.2; 95% confidence interval, 1.47-7.17) as a significant survival predictor. This was not supported by multivariate modeling. The rate of infectious-related adverse events was similar between groups. In conclusion, anakinra improved overall survival and invasive ventilation-free survival and was well tolerated in patients with ARDS associated with COVID-19.