Sarilumab

Overview

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.[1][2] WP

Development in ankylosing spondylitis has been suspended after the drug failed to show clinical benefit over methotrexate in a phase II trial.[3] WP

Uses, dosage and effects

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 (DMARDs).[4][5][6] WP

Risks and side effects

Contraindications

In the European Union, 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.[5][6] WP

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 (13.6% vs 0.5%). However, infection rates were similar between both groups (28.8% vs 27.7%).[7] WP

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.[5] WP

Research

COVID-19

A study of 420 patients was halted in September 2020, due to lack of demonstrated effectiveness in treating COVID-19 symptoms.[8] WP

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.[9] WP

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). A study published in March 2023, also failed to demonstrate the efficacy of Sarilumab to treat severe COVID-19.[10][11][12] WP

History

History

In October 2016, the U.S. Food and Drug Administration (FDA) refused approval for marketing as a treatment for rheumatoid arthritis due to good manufacturing practice (GMP) violations. The drug was eventually approved by the FDA on 22 May 2017.[7] WP

Chemistry

Harm reduction information

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User reports

Pop culture

No references added yet.

Sources

1. Other Statement On A Nonproprietary Name Adopted By The USAN Council: Sarilumab
2. Journal / agency Kevzara: Authorisation details
3. Other Sanofi and Regeneron Report Positive Phase 2b Trial Results with Sarilumab in Rheumatoid Arthritis. 12 July 2011
4. Journal / agency Boyce EG, Rogan EL, Vyas D, Prasad N, Mai Y. Sarilumab: Review of a Second IL-6 Receptor Antagonist Indicated for the Treatment of Rheumatoid Arthritis. Annals of Pharmacotherapy. Feb 2018. doi:10.1177/1060028018761599 · PMID 29482351
5. Journal / agency Kevzara: EPAR – Product Information. 26 September 2017
6. Other Drugs.com: Sarilumab. Accessed 29 November 2017 Drugs.com monograph sarilumab
7. Journal / agency Burmester GR, Lin Y, Patel R, van Adelsberg J, Mangan EK, Graham NM, van Hoogstraten H, Bauer D, Ignacio Vargas J, Lee EB. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Annals of the Rheumatic Diseases. May 2017. doi:10.1136/annrheumdis-2016-210310 · PMID 27856432 · PMC5530335
8. Other Sanofi halts tests of arthritis drug for use as a COVID-19 treatment
9. Other Roberts M. Two more life-saving Covid drugs discovered. 7 January 2021
10. Journal / agency Yu SY, Koh DH, Choi M, Ryoo S, Huh K, Yeom JS, Yoon YK. Clinical efficacy and safety of interleukin-6 receptor antagonists (tocilizumab and sarilumab) in patients with COVID-19: a systematic review and meta-analysis. Emerging Microbes & Infections. December 2022. doi:10.1080/22221751.2022.2059405 · PMID 35343397 · PMC9037226
11. Journal / agency Sivapalasingam S, Lederer DJ, Bhore R, Hajizadeh N, Criner G, Hosain R, Mahmood A, Giannelou A, Somersan-Karakaya S, O'Brien MP, Boyapati A, Parrino J, Musser BJ, Labriola-Tompkins E, Ramesh D, Purcell LA, Gulabani D, Kampman W, Waldron A, Ng Gong M, Saggar S, Sperber SJ, Menon V, Stein DK, Sobieszczyk ME, Park W, Aberg JA, Brown SM, Kosmicki JA, Horowitz JE, Ferreira MA, Baras A, Kowal B, Thomas DiCioccio A, Akinlade B, Nivens MC, Braunstein N, Herman GA, Yancopoulos GD, Weinreich DM. Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial. Clinical Infectious Diseases. August 2022. doi:10.1093/cid/ciac153 · PMID 35219277 · PMC8903479
12. Journal / agency Mastrorosa I, Gagliardini R, Segala FV, Mondi A, Lorenzini P, Cerva C, Taddei E, Bai F, Vergori A, Marcantonio N, Pinnetti C, Cicalini S, Murri R, Mazzotta V, Camici M, Mosti S, Bini T, Maffongelli G, Beccacece A, Milozzi E, Iannetta M, Lamonica S, Fusto M, Plazzi MM, Ottou S, Lichtner M, Fantoni M, Andreoni M, Sarmati L, Cauda R, Girardi E, Nicastri E, D'Arminio Monforte A, Palmieri F, Cingolani A, Vaia F, Antinori A. Sarilumab plus standard of care vs standard of care for the treatment of severe COVID-19: a phase 3, randomized, open-labeled, multi-center study (ESCAPE study). eClinicalMedicine. March 2023. doi:10.1016/j.eclinm.2023.101895 · PMID 36936403 · PMC9999914

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