FDA Approves Kevzara for Moderate to Severe RA

In May, the FDA approved Kevzara (sarilumab), a human monoclonal antibody that targets and suppresses the activity of the interleukin-6 receptor (IL-6R). This receptor is a cytokine that can lead to RA inflammation. Kevzara is indicated for use in adults with moderate to severe RA, whose condition is not improved by one or more DMARDs (disease modifying antirheumatic drugs). Kevzara can be used alone or with other DMARDs, such as methotrexate. The medication comes in the form of a self-administered subcutaneous injection.

"In the clinical trial program, sarilumab demonstrated statistically significant, clinically-meaningful improvements in adult patients with rheumatoid arthritis by reducing signs and symptoms and improving physical function, resulting in significantly less radiographic progression of structural damage of RA. Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF class, and is a welcome new option for patients and their physicians.”
-Alan Kivitz, M.D., CPI, Investigator in the global SARIL-RA clinical program for sarilumab, and Founder and Medical Director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center1

Several clinical trials informed researchers and the FDA on Kevzara’s safety and efficacy. These trials were called the MOBILITY study and the TARGET study. Together, these Phase 3 trials enrolled approximately 2,900 individuals with moderate to severe RA that was unable to be controlled by other treatments. Across both studies, Kevzara, alongside DMARDs, led to significant improvements in physical function, signs and symptoms of RA, and radiographic progression of the condition.

Specifically, the MOBILITY study analyzed Kevzara alongside methotrexate, and compared outcomes to the combination of a placebo with methotrexate. Ultimately, after 24 weeks, those receiving Kevzara and methotrexate together achieved a greater improvement in signs and symptoms than those on methotrexate and placebo. Additionally, at 52 weeks, individuals in the treatment group demonstrated significantly less radiographic progression of condition-related structural damage. This second finding was a key endpoint of the study. Physical function was also significantly improved for the treatment group at 16 weeks.

The TARGET study assessed Kevzara alongside other DMARDs, and compared individuals receiving this combination to controls taking a placebo with DMARDs. Overall, this study found that those in the treatment group showed reduced signs and symptoms of RA, as well as improvements in physical function when compared to their control counterparts at the 12 and 24-week checkpoints.

There is an increased risk of developing infection with Kevzara, with the most common side effects being a low level of neutrophils (an important white blood cell protecting against infection), upper respiratory infection, urinary tract infection, injection site irritation, and fluctuations in the level of certain liver enzymes. The marketers of Kevzara, Sanofi Genzyme and Regeneron, are launching a program called KevzaraConnect designed to provide support, financial assistance, and nurses on-call 24/7 to help individuals using the medication. Earlier this year, Kevzara was approved for use in Canada and Europe.

Before taking Kevzara, it’s important to alert your provider if you have stomach or liver issues, have any current infections, are scheduled to receive or have recently received a vaccine, are breastfeeding, pregnant, or planning to become pregnant, or are scheduled to have surgery in the near future. Additionally, your provider should be alerted of any and all other medications you are currently taking.

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