 | Parts of this article (those related to lack of effectiveness against theOmicron variant) need to beupdated. Please help update this article to reflect recent events or newly available information.(January 2022) |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | IL-6R |
| Clinical data | |
| Trade names | Kevzara |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a617032 |
| License data | |
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Bioavailability | 80% |
| Metabolism | likelyproteases |
| Eliminationhalf-life | 21 days (steady-state, estimated) |
| Identifiers | |
| CAS Number | |
| ChemSpider |
|
| UNII | |
| KEGG |
|
| Chemical and physical data | |
| Formula | C6388H9918N1718O1998S44 |
| Molar mass | 144164.28 g·mol−1 |
 N Y (what is this?) (verify) | |
Sarilumab, sold under the brand nameKevzara, is a humanmonoclonal antibody medication against theinterleukin-6receptor.[5]Regeneron Pharmaceuticals andSanofi developed the drug for the treatment ofrheumatoid arthritis (RA), for which it received USFDA approval on 22 May 2017 andEuropean Medicines Agency approval on 23 June 2017.[6]
Development inankylosing spondylitis has been suspended after the drug failed to show clinical benefit overmethotrexate in a phase II trial.[7]
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).[9][10]
In the European Union, sarilumab is contraindicated in people with active, severe infections.[9] 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.[10]
The MONARCH trial suggested a significantly higher incidence ofneutropenia in patients receiving 200 mg sarilumab every 2 weeks, compared to patients being treated withadalimumab (13.6% vs 0.5%). However, infection rates were similar between both groups (28.8% vs 27.7%).[11]
Other common side effects that occurred in 1% to 10% of patients includedthrombocytopenia (lowplatelet count), infections of theupper respiratory tract and theurinary tract, oral herpes,hyperlipidaemia, andinjection site reactions such as pain or redness.[9]
On 15 May 2013, both companies announced that 2 new trials were starting (COMPARE and ASCERTAIN) and the first patients had already been enrolled.[12]
In June 2015, a phase III trial (withmethotrexate) for RA reported meeting its three coprimary endpoints.[13]
In November 2015, the SARIL-RA-TARGET trial reported good results (meeting both its coprimary end points).[14]
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.[11]
In July 2019, a multi-center trial was launched to study 'Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis.'[15]
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.[11] The drug was eventually approved by the FDA on 22 May 2017.
A study of 420 patients was halted in September 2020, due to lack of demonstrated effectiveness in treatingCOVID-19 symptoms.[16]
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, 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 patients' recovery and reducing the length of time that critically-ill patients need to spend in intensive care by about a week[17]
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).[18][19]
{{cite web}}: CS1 maint: overridden setting (link)
