Product Code Database
Sarilumab, sold under the brand name Kevzara, is a human monoclonal antibody medication against the interleukin-6 receptor. Regeneron Pharmaceuticals and Sanofi developed the drug for the treatment of rheumatoid arthritis (RA), for which it received US FDA approval on 22 May 2017 and European Medicines Agency approval on 23 June 2017.
Development in ankylosing spondylitis has been suspended after the drug failed to show clinical benefit over methotrexate in a phase II trial.
Other common side effects that occurred in 1% to 10% of patients included thrombocytopenia (low platelet count), infections of the upper respiratory tract and the urinary tract, oral herpes, hyperlipidaemia, and injection site reactions such as pain or redness.
In June 2015, a phase III trial (with methotrexate) for RA reported meeting its three coprimary endpoints.
In November 2015, the SARIL-RA-TARGET trial reported good results (meeting both its coprimary end points).
In November 2016, the MONARCH phase III trial comparing sarilimab to adalimumab (an anti-TNF) found sarilumab superior at reducing the DAS28-ESR score in patients with RA after 24 weeks.
In July 2019, a multi-center trial was launched to study 'Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis.'
On 7 January 2021, following results from the REMAP-CAP trial, Tocilizumab and Sarilumab were added to the UK recommended list for COVID-19 treatment, the number needed to treat is 12, meaning for every 12 intensive care unit patients treated 1 additional person survives compared to treatment as normal, also speeding up patients' recovery and reducing the length of time that critically-ill patients need to spend in intensive care by about a week
Tocilizumab seems to be more beneficial, whereas the clinical efficacy of Sarilumab has not been established as data on decreased mortality was often not significant. The number of trials did not allow for the identification of a specific patient subset that benefits the most from Sarilumab treatment, yet (May 2022).- Yu SY, Koh DH, Choi M, et al. Clinical efficacy and safety of interleukin-6 receptor antagonists (tocilizumab and sarilumab) in patients with COVID-19: a systematic review and meta-analysis. Emerg Microbes Infect. 2022;11(1):1154-1165. doi:10.1080/22221751.2022.2059405- Sivapalasingam S, Lederer DJ, Bhore R, et al. Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19: A Randomized Clinical Trial published. Clin Infect Dis. 2022;ciac153. doi:10.1093/cid/ciac153A study published in March 2023, also failed to demonstrate the efficacy of Sarilumab to treat severe COVID-19
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