Sarilumab plus standard of care

Background

Among interleukin-6 inhibitors suggested for use in COVID-19, there are few robust evidences for the efficacy of sarilumab. Herein, we evaluated the efficacy and safety of sarilumab in severe COVID-19.

Methods

In this phase 3, open-labeled, randomized clinical trial, conducted at 5 Italian hospitals, adults with severe COVID-19 pneumonia (excluding mechanically ventilated) were randomized 2:1 to receive intravenous sarilumab (400 mg, repeatable after 12 h)

Findings

Between May 2020 and May 2021, 191 patients were assessed for eligibility, of whom, excluding nine dropouts, 176 were assigned to arm A (121) and B (55). At day 30, no significant differences in the primary endpoint were found (88% [95% CI 81-94] in arm A

Interpretation

The efficacy of sarilumab in severe COVID-19 was not demonstrated both in the overall and in the stratified for severity analysis population. Exploratory analyses suggested that subsets of patients with lower CRP values or lower lymphocyte counts might have had benefit with sarilumab treatment, but this finding would require replication in other studies. The relatively low rate of concomitant corticosteroid use, could partially explain our results.

Funding

This study was supported by INMI "Lazzaro Spallanzani" Ricerca Corrente Linea 1 on emerging and reemerging infections, funded by Italian Ministry of Health.

Informations de copyright

© 2023 The Authors.

Déclaration de conflit d'intérêts

Andrea Antinori has served as a paid consultant to Astra-Zeneca, Gilead Sciences, GlaxoSmithKline, Janssen-Cilag, Merck Sharp and Dohme, Roche, Theratotecnologies and ViiV Healthcare and received research institutional grants from Gilead Sciences, Janssen-Cilag and ViiV Healthcare, payment or honoraria from Gilead Science and ViiV Healthcare and support for attending meetings and/or travel from ViiV Healthcare and AbbVie. Marta Camici received institutional grant, support for attending meetings and/or travel and speakers' honoraria from Gilead Sciences. Stefania Cicalini reports consulting fees paid to self from ViiV Healthcare, Jansen-Cilag, Merck Sharp and Dohme and Gilead Sciences and payment or honoraria from ViiV Healthcare, Jansen-Cilag, Merck Sharp and Dohme and Gilead Sciences. Roberta Gagliardini reports payments to their institution from Gilead Sciences, speakers' honoraria/educational activities for ViiV Healthcare, Merck Sharp and Dohme and Gilead Sciences, support for attending meetings and/or travel from ViiV Healthcare and advisor for Theratechnologies, Janssen-Cilag and Gilead Sciences. Enrico Girardi reports grants from Gilead Sciences and Mylan and fees for lectures and expertise from Gilead Sciences. Marco Iannetta received research institutional grant from Gilead Sciences and personal honoraria from Biogen Italia, AIM Educational and MICOM srl. Ilaria Mastrorosa received institutional research grant and support for attending meetings and/or travel from Gilead Sciences. Annalisa Mondi received speakers' honoraria from Gilead Sciences and ViiV Healthcare and participated in advisory boards sponsored by ViiV Healthcare. Emanuele Nicastri reports grants from Sobi and Roche, payment or honoraria from Eli Lilly, Gilead Sciences, Roche and Sobi, patents planned from Dompè and advisor for Eli Lilly and Roche. Carmela Pinnetti received personal fee for a case presentation and travel grant from Gilead Sciences and participated in an advisory board for Janssen-Cilag. Alessandra Vergori received institutional grant from Gilead Sciences, speakers’ honoraria/educational activities from Merck Sharp and Dohme, ViiV Healthcare and Janssen-Cilag and advisor for Janssen-Cilag. The other co-authors declare no conflicts of interests for this work.