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Novartis announces publication in The Lancet


29 June, 2015  

In the FUTURE 2 study, secukinumab demonstrated rapid onset of action, was significantly superior to placebo in improving signs and symptoms of psoriatic arthritis (PsA), with efficacy sustained over one year. (1)

Secukinumab is the first interleukin-17A inhibitor to demonstrate significant improvement of joint and skin symptoms of PsA, and provides physical functioning and quality of life benefits. (1) Global regulatory submissions have been filed for secukinumab in PsA and ankylosing spondylitis, another serious long-term inflammatory disease.

Novartis announced that new one-year results from the pivotal Phase III FUTURE 2 study of secukinumab in psoriatic arthritis (PsA) were published in The Lancet following fast-track review. Secukinumab is the first interleukin-17A (IL-17A) inhibitor to demonstrate efficacy in a Phase III study in adult patients with active PsA. (1) PsA is a long-term, debilitating, inflammatory disease associated with joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage. (2) Between 0.3 and 1% of the general population may be affected by PsA, which could mean more than 600,000 people in the UK have the condition. (3,4)

The new study results published in The Lancet show improvements observed with subcutaneous secukinumab 300mg and 150mg were sustained over one year of treatment in the majority of patients (64% for both doses), as measured by the American College of Rheumatology response criteria (ACR 20). (1)

Moreover, ACR 50 response rates were also sustained to one year in secukinumab 300mg and 150mg treatment arms (44% and 39% respectively). Secukinumab met the primary endpoint of the study, which was ACR 20 at week 24 with response rates significantly higher in the secukinumab 300mg (54%; p<0.0001) and 150mg (51%; p<0.0001) groups versus placebo (15%), with clinical improvements observed as early as week 3. (1) ACR 20 and 50 are standard tools used to assess improvement of PsA signs and symptoms, and represent a 20% and 50% improvement from baseline, respectively. (5)

Dimitrios Georgiopoulos, UK Medical Director, Novartis Pharmaceuticals said, “This is exciting data. Secukinumab is now the first IL-17A inhibitor to show consistent efficacy through one year in psoriatic arthritis, psoriasis, and ankylosing spondylitis. In the UK we have already begun to see the impact that secukinumab can have in achieving high levels of skin clearance for psoriasis patients, since it was licensed in this indication earlier this year. Following global regulatory submissions for secukinumab in both psoriatic arthritis and ankylosing spondylitis (AS), we will continue to work to bring this important advance to patients with these debilitating inflammatory conditions.

Secukinumab 300mg also significantly improved a key secondary endpoint, which was improvement in psoriasis symptoms, as measured by 90% improvements in Psoriasis Area and Severity Index score (PASI 90). (1) Achieving PASI 90 means that patients can attain almost clear skin. (6) This is important as the majority of people living with PsA have a history of, or concomitant, psoriasis, (3) another long-term condition which is characterised by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain. (7,8)

Clinical benefits were observed in both anti-TNF-naïve patients and those with an inadequate response to anti-TNFs. (1) This is important as many patients do not respond to, or tolerate, these therapies and approximately 40% of people are dissatisfied with current treatments indicating a significant unmet need. (9,10)
Secukinumab was well tolerated in FUTURE 2, with a safety profile consistent with that observed in the psoriasis clinical trial programme involving over 3400 patients. (1,11–13) The most common adverse events (AEs) were upper respiratory tract infections and the common cold. (1)

References:

  1. McInnes IB et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in psoriatic arthritis: a randomized, double-blind, placebo-controlled, phase 3 trial (FUTURE 2). Lancet 2015;(15):61134–5.
  2. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs 2014;74:423–41.
  3. Gladman DD et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005;64:ii14–ii17.
  4. Office for National Statistics. Available at: http://www.ons.gov.uk/ons/guide-method/compendiums/compendium-of-uk-statistics/population-and-migration/index.html.
  5. 5.European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Guidelines on clinical investigation of medicinal products indicated for the treatment of psoriatic arthritis. 2006. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003413.pdf. Accessed 17 June 2015.
  6. European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Guidelines on clinical investigation of medicinal products indicated for the treatment of psoriasis. 2004. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf. Accessed 9 February 2015.
  7. Stern RS et al. Psoriasis Is Common, Carries a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction. J Investig Dermatol Symp 2004;9(2):136–9.
  8. Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009;361(5):496–509.
  9. Rapp SR et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999;41(3 Pt 1):401–7.
  10. Boehncke WH, Menter A. Burden of disease: psoriasis and psoriatic arthritis. Am J Clin Dermatol 2013;14:377–88.
  11. Armstrong A et al. Undertreatment, Treatment Trends, and Treatment Dissatisfaction Among Patients With Psoriasis and Psoriatic Arthritis in the United States: Findings From the National Psoriasis Foundation Surveys, 2003-2011. JAMA Dermatol 2013;149(10):1180–5.
  12. Langley RG et al. Secukinumab in plaque psoriasis: results of two phase three trials. N Engl J Med 2014;371(4):326–38.
  13. Blauvelt A, Prinz J. Secukinumab Administration by Pre-filled Syringe: Efficacy, Safety, and Usability Results from a Randomized Controlled Trial in Psoriasis (FEATURE). Br J Dermatol 2015;172:484–93.
  14. Paul C et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol 2014:1–9.
  15. Kirkham BW, Kavanaugh A, Reich K. Interleukin-17A: a unique pathway in immune-mediated diseases: psoriasis, psoriatic arthritis and rheumatoid arthritis. Immunology 2014;141:133–42.
  16. Sieper et al. Secukinumab Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis: 52-Week Data from MEASURE 2, A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with Subcutaneous Loading and Maintenance Dosing. EULAR Annual Meeting, Rome Italy, 2015. Oral presentation (presentation number 168).
  17. Van Baarsen LGM et al. IL-17 levels in synovium of patients with rheumatoid arthritis, psoriatic arthritis and osteoarthritis: Target validation in various forms of arthritis. Ann Rheum Dis 2011;70:A79.
  18. NICE. Final appraisal determination Secukinumab for treating moderate to severe plaque psoriasis. 1–58 (2015).
  19. Scottish Medicines Consortium. secukinumab (Cosentyx) Final assessment. 12 (2015).