Sanofi and Regeneron’s Kevzara has been approved by European regulators to treat moderately to severely active rheumatoid arthritis (RA) in adult patients.
The decision enables doctors to prescribe the drug in combination with methotrexate for patients who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), though it can also be used as monotherapy if patients are unable to take methotrexate.
RA is a chronic inflammatory autoimmune disease that attacks the tissues of the joints, causing inflammation, pain, and eventually joint damage and disability, thought to affect more than 400,000 people in the UK alone and 2.9 million in Europe.
“Despite of a wide range of treatment options, many people with RA do not respond adequately to existing treatments or experience loss of response to therapy over time. Symptoms can be debilitating and greatly impact the ability to perform daily activities,” said Professor Peter Taylor, consultant rheumatologist, Oxford University Hospitals.
“New treatment options are an important part of the solution to this problem.”
Kevzara (sarilumab) is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to inhibit IL-6R mediated signalling. In excess and over time, IL-6 can contribute to the inflammation associated with RA.
The drug’s approval was based on results from seven Phase III trials in the global SARIL-RA clinical development programme of more than 3,300 adults with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs, which showed that the drug induced statistically significant, clinically-meaningful improvements in patients.
Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20 percent improvement (ACR20), were: 61 percent in the sarilumab 200mg group; 56 percent in the sarilumab 150mg group; and 34 percent in the placebo group, all in combination with DMARD therapy.