Sarilumab, sold under the brand nameKevzara, is a medication used to treatrheumatoid arthritis (RA).^[1] It is used for moderate to severe disease when other treatments have not worked.^[1] It may also may be used for severeCOVID-19 whentocilizumab is not available.^[2] It is used byinjection under the skin.^[1]

The most common side effect is infection.^[3] Other side effects may includelow neutrophils,low platelets,abnormal lipids, liver problems,allergic reactions, andcancer.^[3][4] Pain may occur at the site of injection.^[1] It is amonoclonal antibody which attaches to and blocks theinterleukin-6receptor.^[1]

Sarilumab was approved for medical use in the United States and Europe in 2017.^[4][1] In the United States it costs about 7,700 USD per month as of 2021.^[5] In the United Kingdom this amount costs theNHS about £1800.^[6] In Canada the monthly cost is about 1,500 CAD as of 2017.^[7]

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.^[8] It can be used alone or in combination withmethotrexate or otherdisease-modifying antirheumatic drugs (DMARDs).^[1]

COVID-19

A study of 420 patients was halted in September 2020, due to lack of demonstrated effectiveness in treatingCOVID-19 symptoms.^[9]

On January 7, 2021, following a REMAP-CAP trial,tocilizumab and sarilumab were added to the UK recommended list for COVID-19 treatment, thenumber 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 people's recovery and reducing the length of time in intensive care by about a week.^[10]

Dosage

It is typically use at a dose of 200 mg every two weeks.^[1]

Blood monitoring is recommended before starting treatment and a month or two afterwards.^[3][4] Further testing is than recommended every 3 months.^[4]

For COVID19 it is used as a single dose of 400 mg in 100 ml ofnormal saline over 1 hour.^[11]

Contraindications

In the European Union, sarilumab is contraindicated in people with active, severe infections.^[1] While this is not listed as a contraindication under the US FDA approval, there is aboxed warning that recommends testing for hiddentuberculosis infection before treatment and monitoring for signs of an infection during therapy with sarilumab.^[12]

Side effects

There may be a higher rate ofneutropenia in people receiving 200 mg sarilumab every 2 weeks, compared to people being treated withadalimumab (14% vs 0.5%). However, infection rates were similar between both groups (29% vs 28%).^[13]

Other common side effects that occurred in 1% to 10% includedthrombocytopenia (lowplatelet count), infections of theupper respiratory tract and theurinary tract, oral herpes,hyperlipidaemia, and reactions at the injection site.^[1]

History

In October 2016, the U.S.Food and Drug Administration (FDA) refused approval for marketing as a treatment for rheumatoid arthritis due togood manufacturing practice (GMP) violations.^[13] The drug was eventually approved by the FDA on 22 May 2017.

Research

Rheumatoid arthritis

On May 15, 2013, both companies announced that 2 new trials were starting (COMPARE and ASCERTAIN) and the first patients had already been enrolled.^[14]

In June 2015, a phase III trial (withmethotrexate) for RA reported meeting its three coprimary endpoints.^[15]

In November 2015, the SARIL-RA-TARGET trial reported good results (meeting both its coprimary end points).^[16]

In November 2016, theMONARCH phase III trial comparing sarilimab toadalimumab (an anti-TNF) found sarilumab superior at reducing theDAS28-ESR score in patients with RA after 24 weeks.^[13]

In July 2019, a multi-center trial was launched to study 'Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis.'^[17]

Ankylosing spondylitis

Development inankylosing spondylitis has been suspended after the drug failed to show clinical benefit overmethotrexate in a phase II trial.^[18]

References

External links

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