Final NICE nod for Sanofi’s Kevzara

The National Institute for Health and Care Excellence has issued final guidance backing Sanofi’s Kevzara as a new treatment option for adults with severe, active rheumatoid arthritis (RA).

The guidelines green light funding for routine use of the drug on the National Health Service in England in combination with methotrexate (MTX) as a treatment option for adults whose disease has responded inadequately to intensive therapy with conventional or other disease modifying anti-rheumatic drugs (DMARDs).

The guidance also recommends for monotherapy in adults with severe, active rheumatoid arthritis who are intolerant to MTX and cannot have rituximab.

More than 400,000 people in the UK live with RA, their daily lives significantly impacted by symptoms of severe pain, swelling, stiffness, or fatigue. As many patient fail to respond adequately to existing therapies or experience loss of response over time new treatment options are urgently needed.

Kevzara (sarilumab) is a fully human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to block pro-inflammatory IL-6 mediated signalling. IL-6 is a protein in the body that, in excess and over time, can contribute to both the pathological inflammation and joint destruction that are associated with RA.

The drug’s approval in Europe in June 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.