Kevzara (sarilumab) is an injectable prescription medicine developed by Regeneron Pharmaceuticals and Sanofi to treat adults with moderate to severely active rheumatoid arthritis (RA) who have not responded to or cannot tolerate disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate.
The drug is now commercially available in the United States and the 28-member European Union after its recent approval by the U.S Food and Drug Administration (FDA) and the European Commission.
Kevzara is also under investigation as a potential treatment for juvenile arthritis (JA) — a group of diseases that cause pain, swelling, stiffness, and loss of motion in the joints of children.
RA and JA are considered to be autoimmune disorders. This means that instead of helping to fight infection and threats, the immune system of patients with those conditions attacks healthy tissues in the body.
How Kevzara works
Kevzara is a human monoclonal antibody, a type of protein designed to attach to and block the interleukin-6 receptor. Interleukin-6 is involved in the inflammation process and is found at high levels in the joints of RA patients. By preventing the attachment of interleukin-6 to its receptors, Kevzara reduces inflammation and other symptoms associated with RA.
Kevzara in clinical trials
The FDA based its approval of Kevzara on several clinical trials that incorporated data from more than 3,300 adults with moderately to severely active RA who responded inadequately to, or could not tolerate, one or more biologic or non-biologic DMARDs. The results of these trials showed that Kevlar managed to reduce signs, symptoms and progression of the disease while improving physical function, with more patients achieving clinical remission over 24 weeks.
Kevzara is now being studied in Phase 2 clinical trials (NCT02991469 and NCT02776735) to treat JA. Both studies are currently recruiting patients and aim to identify the dose and regimen to be used in further safety and efficacy studies.
The first trial will evaluate children and adolescents, ages 2 to 17, with polyarticular JA, while the second will evaluate children and adolescents, ages 1 to 17 years, with systemic JA. The primary outcomes of both trials will likely be released later this year or in 2018.
Other details
Kevzara may be used on its own in case of intolerance to methotrexate, or when treatment with methotrexate is inappropriate. The recommended injection is 200 mg once every two weeks, with the possibility of reducing the dosage to 150 mg if routine blood tests turn up any abnormalities.
The most frequent adverse reactions observed with Kevzara in clinical studies were unusually low levels of neutrophils — a type of white blood cells — as well as increased levels of an enzyme called alanine aminotransferase in the blood, which is a possible sign of liver damage. Other reactions included injection site reaction, upper respiratory infections and urinary tract infections.
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