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NICE Recommends Sanofi’s Kevzara® (sarilumab) for the Treatment of Severe, Active Rheumatoid Arthritis (RA)

• NICE publishes final guidance recommending Kevzara® (sarilumab) as an option for treating adults with active, severe rheumatoid arthritis who respond inadequately to intensive therapy with conventional or other disease modifying anti-rheumatic drugs (DMARDs)
• RA is a progressive, chronic disease, most common in people aged 30-50 years1
• 75% of patients diagnosed while of working age2

 

Guildford, UK – 1 November, 2017 - Sanofi and its specialty care global business unit, Sanofi Genzyme, today announced that the National Institute for Health and Care Excellence (NICE) issued final guidance recommending Kevzara® (sarilumab) for routine use on the National Health Service (NHS) in England in combination with methotrexate (MTX) as a treatment option for adults with severe, active rheumatoid arthritis whose disease has responded inadequately to intensive therapy with conventional or other disease modifying anti-rheumatic drugs (including at least one biological DMARDs) and who cannot have rituximab.3 The final guidance also recommends Kevzara® (sarilumab) for monotherapy in adults with severe, active rheumatoid arthritis who are intolerant to MTX and cannot have rituximab.3

“NICE’s timely appraisal and positive final guidance confirms the value Kevzara can bring to patients with rheumatoid arthritis and their clinicians,” said Peter Kuiper, General Manager UK & Ireland, Sanofi Genzyme. “As there are still many patients who fail to show an adequate response to current therapies, the availability of Kevzara on hospital formularies as soon as possible can help enable patients to benefit from this treatment option.”

More than 400,000 people in the UK live with RA,4 and the impact that symptoms of severe pain, swelling, stiffness, or fatigue5 have on daily life is often underestimated. While RA is typically thought of as a disease of the joints, its impact extends beyond bones and cartilage. People with the disease are at an increased risk of developing one or more additional conditions co-occuring with their RA, such as cardiovascular disease.6 In addition, a review of 13,189 patients showed that 38% of people with RA may experience depression.7 Patients with RA who experience depression also have poorer long-term RA outcomes, including increased pain, more comorbidities and increased mortality levels.7

Kevzara® (sarilumab) will be available in both a pre-filled syringe and buttonless autoinjector, which has been co-created with RA patients to improve administration for those people with reduced mobility in their hands. Kevzara® is dosed every two weeks.3

The final guidance is in line with the Final Appraisal Determination published by NICE in September this year. The National Health Service (NHS) is legally obliged to provide funding within three months of the final guidance being published.

About Kevzara® (sarilumab)

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.8 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. 8 Kevzara® (sarilumab) is administered via an innovative ‘auto-injector’ device (that was co-created with RA patients), or by using a pre-filled syringe.

The efficacy and safety of Kevzara® (sarilumab) were assessed in three randomised, double-blind, controlled multicentre studies (MOBILITY and TARGET were placebo-controlled studies and MONARCH was an active comparator-controlled study) in adult patients with moderately to severely active rheumatoid arthritis.8 In the MONARCH study, sarilumab demonstrated clinically meaningful improvements in adult patients with moderately to severely active RA, reducing signs and symptoms experienced by people with RA and improving physical function compared with a tumour necrosis factor (TNF) inhibitor.9

On 23 June, 2017, Kevzara® (sarilumab) was granted EU marketing authorisation in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The licence also permits use as monotherapy in patients who are intolerant of MTX or for whom treatment with MTX is inappropriate.8

Kevzara® (sarilumab) was developed jointly by Sanofi and Regeneron. Full summary of product characteristics can be accessed at http://www.medicines.org.uk/emc/medicine/33836 .

About Rheumatoid Arthritis (RA)

Rheumatoid arthritis (RA) is both progressive and chronic, and is caused by a malfunction of the immune system. People with RA can suffer from severe pain, swelling, stiffness, or fatigue as the immune system attacks the tissues of the joints, causing inflammation and destroying bone and cartilage.5 The impact that these symptoms and complications have on daily life is often underestimated.

RA can affect people of any age, but is most common in people aged between 30-50 years1 with 75% of patients diagnosed while of working age.2 Up to two in five people with inadequately treated RA will have stopped working within five years of being diagnosed.10

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life.

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Learn more at www.sanofi.co.uk.

References

  • British Society of Immunology. ‘Rheumatoid Arthritis.’ Available at: https://www.immunology.org/public-information/bitesized-immunology/immune-dysfunction/rheumatoid-arthritis.  (Accessed October 2017).
  • National Rheumatoid Arthritis Society. ‘Right answer? Key questions for my new MP.’ Available at: http://www.nras.org.uk/data/files/Get%20Involved/Campaign/Right%20Answer%20download%20booklet.pdf. (Accessed October 2017).
  • NICE. Sarilumab for previously treated moderate to severe active rheumatoid arthritis [ID994]. Available at:  https://www.nice.org.uk/guidance/ta485. (Accessed October 2017).
  • Arthritis Research UK. ‘State of musculoskeletal health 2017.’ Available at: http://www.arthritisresearchuk.org/research/news-for-researchers/2017/june/state-of-musculoskeletal-health-2017.aspx. (Accessed October 2017).
  • Rheumatoid Arthritis ‘What is rheumatoid arthritis?’ Available at: https://www.rheumatoidarthritis.org/ra/. (Accessed October 2017).
  • Dougados M, Soubrier M, Antunez A, et al. Prevalence of comorbidities in rheumatoid arthritis and evaluation of their monitoring: results of an international, cross-sectional study (COMORA). Ann Rheum Dis. 2014 Jan;73(1):62-8.
  • Matcham F, Rayner L, Steer S et al., The prevelance of depression in rheumatoid arthritis: a systematic review and meta-analysis. Rheumatology, Volume 52, Issue 12, 1 December 2013, Pages 2136–2148
  • Kevzara (sarilumab) summary of product characteristics. Available at: http://www.medicines.org.uk/emc/medicine/33836. (Accessed October 2017).
  • Burmester GR, Lin Y, Patel R, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2017 May;76(5):840-847.
  • Bevan S, Quadrello T, McGee R, et al. ‘Fit For Work? Musculoskeletal Disorders in the European Workforce.’ The Work Foundation, London, 2009.

Date of preparation: October 2017 - Job bag number:SAGB.SARI.17.10.1348

Updated: November 01, 2017

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