Sanofi and Regeneron Pharmaceuticals have gained approval from the US Food & Drug Administration (FDA) for use of Kevzara (sarilumab) for treating patients with rheumatoid arthritis. The prescription medication will be available to patients who do not respond to, or are intolerant, to disease modifying anti-rheumatic drugs (DMARDs), such as Imuran (azathioprine) or Trexall (methotrexate).
The drug may be prescribed as part of monotherapy or in combination with methotrexate and other DMARDs. Sarilumab is a monoclonal antibody binding to the interleukin-6 receptor. It will be available through prescription in pharmacies as an injectable solution in prefilled syringes and pens, which patients will administer themselves once every two weeks.
Data from more than 2,900 adults with moderate to severe rheumatoid arthritis was examined in two Phase 3 clinical trials. Alan Kivitz, MD, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Pennsylvania, who was part of the sarilumab trials, revealed adult patients given Kevzara rather than a placebo demonstrated "statistically significant, clinically-meaningful improvements." The drug was demonstrably effective in "reducing signs and symptoms, improving physical function, and resulting in significantly less radiographic progression of structural damage of rheumatoid arthritis", he added.
Rheumatoid arthritis is an autoimmune disease in which the body's immune system turns on the joints, causing inflammation, swelling and pain. It affects around 1.5 million people in the US and is more likely to be developed by women than men. Other risk factors include genetics, hormones and lifestyle, for example obesity and smoking. While it cannot be cured, there are effective self-treatments and medication to manage symptoms and alleviate the discomfort rheumatoid arthritis causes.
May is National Arthritis Awareness Month, with organizations such as the Arthritis Foundation focusing to raise awareness of the condition and the treatments available. Arthritis is the number one cause of disability in the US, affecting one in five adults and accounting for nearly one million hospitalizations each year. Rheumatoid arthritis is one of the most common forms of arthritis, along with osteoarthritis. Commenting on the FDA approval of Kevzara, CEO of Sanofi Olivier Brandicourt, MD said: "Despite the many advances made in the treatment of rheumatoid arthritis, patients continue to need new treatment options."
Patients with arthritis may benefit from increasing their activity levels, losing weight and protecting joints by avoiding undue strain and repetitive activities. More than one-third of obese adults have arthritis and more than half of adult diabetics also have arthritis in one form or another. The Centers for Disease Control and Prevention (CDC) highlights the importance of seeing a doctor for an early diagnosis and to begin a course of treatment, which may involve lifestyle changes and prescriptions of anti-rheumatic drugs.
Before starting on a course of Kevzara, patients should ensure they inform their healthcare provider if they have: an infection, diabetes, HIV, a weakened immune system, tuberculosis or hepatitis.
For more information on Kevzara (sarilumab), its uses and risks, visit the link below: