What is Kevzara - Sarilumab used for and what is it used for?
Kevzara is a medicine used to treat adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Kevzara is used when treatment with one or more medicines known as disease-modifying antirheumatic drugs (DMARDs) has not proved to be sufficiently effective or has caused serious side effects. It is used with methotrexate (a DMARD) but also in monoterpaia if the patient cannot take methotrexate.
Kevzara contains the active substance sarilumab.
How is Kevzara - Sarilumab used?
Kevzara is available as a solution for injection in pre-filled pens and in pre-filled syringes (150 mg and 200 mg). The recommended dose is 200 mg given as a subcutaneous injection once every two weeks.
Treatment should be discontinued in patients who develop serious infections until they are controlled. In subjects with abnormal blood tests, the dose may need to be reduced. For more information, see the package leaflet.
Kevzara can only be obtained with a prescription. Treatment should be started and supervised by a doctor experienced in the treatment of rheumatoid arthritis.
How does Kevzara - Sarilumab work?
The active substance in Kevzara, sarilumab, is a monoclonal antibody, which is a type of protein designed to bind to the receptor (target) of a molecule called interleukin 6 and block it. Interleukin 6 causes inflammation and is found at high levels in the joints of patients with rheumatoid arthritis. By preventing interleukin 6 from binding to its receptors, sarilumab reduces inflammation and other symptoms associated with rheumatoid arthritis.
What benefit has Kevzara - Sarilumab shown during the studies?
Three studies involving more than 2 100 adults with rheumatoid arthritis have shown that Kevzara is effective in reducing joint pain and swelling, improving joint movement and slowing joint damage after 24 weeks of treatment.
The first study was conducted on approximately 1 200 patients whose disease had not responded adequately to treatment with methotrexate; patients received Kevzara plus methotrexate or placebo plus methotrexate. 58% of patients treated with Kevzara 150 mg and 66% of patients treated with Kevzara 200 mg experienced a reduction of symptoms equal to or greater than 20%, based on a standard assessment score (ACR 20), compared to 33 % of patients taking placebo.
A second study examined 546 patients who could not take a TNF-α inhibitor (another type of medicine indicated for rheumatoid arthritis) or whose disease had not responded adequately to this inhibitor; all patients received Kevzara or placebo in combination with a DMARD. 56% of patients treated with Kevzara 150 mg and 61% of those treated with 200 mg showed a reduction in symptoms of 20% or more, compared to 34% of patients taking placebo.
A third study involving 369 patients compared Kevzara with adalimumab (another monoclonal antibody indicated for the treatment of rheumatoid arthritis). Patients treated with Kevzara showed greater improvement in joint function than patients treated with adalimumab (based on a standard assessment score called DAS28-ESR).
What are the risks associated with Kevzara - Sarilumab?
The most common side effect with Kevzara (which may affect more than 1 in 10 people) is neutropenia (low levels of neutrophils, a type of white blood cell that fights infection). Increased blood levels of a liver enzyme called ALT (a sign of liver problems), redness of the skin at the injection site, infections of the nose and throat and infections of the structures that carry urine (such as the bladder) are also effects common side effects that may affect up to 1 in 10 people.
Kevzara should not be used in patients with active and severe infections, including infections localized in one area of the body. For the full list of side effects and limitations, see the package leaflet.
Why has Kevzara - Sarilumab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kevzara's benefits are greater than its risks and recommended that it be approved for use in the EU.
Kevzara was useful for patients with moderate to severe rheumatoid arthritis whose condition did not improve adequately or who were intolerant to one or more DMARDs. The benefits observed in the studies include reduction of symptoms, improvement in physical function and slowing of progression of joint damage. Kevzara's safety profile was considered acceptable and in line with that of other similar medicines. Most side effects had mild to moderate severity and the most serious side effects were considered to be manageable with dose reduction or treatment interruption.
What measures are being taken to ensure the safe and effective use of Kevzara - Sarilumab?
The company that markets Kevzara will provide a warning sheet for patients, which highlights the risk of serious infections, neutropenia and intestinal perforation (a hole that develops in the wall of the intestine) and which lists the symptoms for which patients must request immediate medical assistance.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kevzara have also been included in the summary of product characteristics and the package leaflet.
More information on Kevzara - Sarilumab
The full EPAR for Kevzara can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Kevzara therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
