Sarilumab


Sarilumab is a human monoclonal antibody against the interleukin-6 receptor. Regeneron Pharmaceuticals and Sanofi developed the drug for the treatment of rheumatoid arthritis, 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.

Medical uses

Sarilumab is used for the treatment of moderately to severely active rheumatoid arthritis in people who have not responded to, or did not tolerate, more conventional treatments. It can be used alone or in combination with methotrexate or other disease-modifying antirheumatic drugs.

Contraindications

In Europe, sarilumab is contraindicated in people with active, severe infections. While this is not listed as a contraindication under the US FDA approval, there is a boxed warning that recommends testing for hidden tuberculosis infection before treatment and monitoring for signs of an infection during therapy with sarilumab.

Side effects

The MONARCH trial suggested a significantly higher incidence of neutropenia in patients receiving 200 mg sarilumab every 2 weeks, compared to patients being treated with adalimumab. However, infection rates were similar between both groups.
Other common side effects that occurred in 1% to 10% of patients included thrombocytopenia, infections of the upper respiratory tract and the urinary tract, oral herpes, hyperlipidaemia, and reactions at the injection site.

Clinical trials

Rheumatoid arthritis

On May 15, 2013, both companies announced that 2 new trials were starting and the first patients had already been enrolled.
In June 2015, a phase 3 trial for RA reported meeting its three coprimary endpoints.
In Nov 2015, the SARIL-RA-TARGET trial reported good results.
In Nov 2016, the MONARCH phase III trial comparing sarilimab to adalimumab 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.'

COVID-19

In March 2020 The Feinstein Institute of Northwell Health announced in March a study on "a human antibody that may prevent the activity" of IL-6 for the treatment of COVID-19.

History

In October 2016 the US FDA refused approval due to GMP violations. The drug was eventually approved by the FDA on 22 May 2017.