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Cosentyx (secukinumab) is the first IL-17A inhibitor to be available for moderate to severe plaque psoriasis in the UK

Novartis Pharmaceuticals UK Limited (Novartis) has announced that Cosentyx (secukinumab) is available for use in the UK for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment.2

Secukinumab is the first and only licensed therapy that blocks the IL-17A protein, found in significantly increased concentrations in psoriasis affected skin.1 – 4 It is the only biologic therapy indicated for first-line systemic use in this group of patients: currently other biologic treatments for psoriasis, including anti-tumour necrosis factor therapies (anti- TNFs) and ustekinumab, are recommended for use after systemic treatments such as ciclosporin and methotrexate, or after use of ultraviolet light therapy, PUVA.2, 5 – 8

Secukinumab has been granted a licence based on efficacy and safety data from four randomised placebo-controlled clinical trials, including the large FIXTURE and ERASURE trials, which demonstrated statistically significant improvements in efficacy compared to NICE-recommended treatment, etanercept (FIXTURE only), or placebo.1, 2 Secukinumab met all primary and secondary endpoints in these trials.1

Professor Chris Griffiths, Foundation Professor of Dermatology, University of Manchester and Consultant Dermatologist at Salford Royal NHS Foundation Trust commented, “Psoriasis is a common, life-long debilitating disease, which has a significant impact on the lives of those afflicted by it. Our aim in psoriasis management is to achieve clear skin for our patients. Secukinumab is a significant treatment advance for moderate to severe plaque psoriasis patients, and is the first IL17-A inhibitor to be licensed. Our participation in the secukinumab clinical trial programme has shown us first-hand its impact on patients by delivering high levels of skin clearance. I am delighted it is now available for patients in the UK.”

Helen McAteer, Chief Executive, Psoriasis Association said, “Psoriasis can be extremely painful, especially for those who are living with the more moderate to severe forms. For many, the impact on their life is all-consuming and detrimental to their physical, emotional and psychological wellbeing. Our research suggests people want treatments that will reduce the visible elements of psoriasis as well as improve their overall well- being. New treatments which achieve this, like secukinumab, will be welcomed by patients.”

Secukinumab has been studied in over 4,000 patients globally across a variety of disease areas.2 The FIXTURE trial demonstrated secukinumab to have a comparable safety profile to etanercept, one of the longest marketed treatment for psoriasis.1

In the ERASURE study:

  • 81.6 per cent of secukinumab patients achieved a 75 per cent improvement of psoriasis by week 121, 2
  • 69.8 per cent of secukinumab patients achieved a 90 per cent improvement of psoriasis by week 161, 2
  • 41.6 per cent of secukinumab patients achieved a 100 per cent improvement of psoriasis (totally clear skin) by week 161, 2

Additionally, the head-to-head FIXTURE study compared secukinumab to a NICE- recommended treatment (etanercept) and demonstrated:

  • secukinumab patients achieved a 50 per cent average improvement in their psoriasis at three weeks – more than twice as fast as etanercept1, 2
  • secukinumab patients saw a significant improvement in their psoriasis and their quality of life when compared to etanercept1, 2

In both FIXTURE and ERASURE, the majority of secukinumab patients maintained the improvement in their psoriasis achieved by week 12 up to week 52 (with continued treatment).1

Psoriasis is a chronic inflammatory disease9 and has been recognised by the National Institute for Health and Care Excellence (NICE) to be ‘more than a skin condition’: it is associated with significant co-morbidities including arthritis, diabetes and hypertension, as well as significant psychological impact.10 – 14 It is estimated that 1.8 million people in the UK live with psoriasis and 20 per cent are thought to have moderate to severe psoriasis.15, 16 A goal of treatment is to achieve a 75 per cent improvement in each individual patients’ symptoms,9 however approximately two in three people in the UK with moderate to severe plaque psoriasis either fail to achieve, or fail to maintain this.17 Poorly controlled moderate to severe psoriasis patients can cost the NHS up to £6million per year.17 – 19

Secukinumab is now licensed in the UK for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment, and will be reviewed by NICE in England and Wales and by the Scottish Medicines Consortium (SMC) in Scotland.20, 21 People seeking further information about secukinumab should contact the Novartis UK medical information team at: [email protected] or on: +44 1276 698370.

Source

1. Langley, R. G. et al. Secukinumab in Plaque Psoriasis – Results of Two Phase 3 Trials. N. Engl. J. Med. 371, 326-38 (2014).

2. Cosentyx – Summary of Product Characteristics (SPC). 1-13 (2015).

3. Johansen, C. et al. Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin. Br. J. Dermatol. 160, 319-324 (2009).

4. Martin, D. A. et al. The emerging role of interleukin-17 in the pathogenesis of psoriasis: preclinical and clinical findings. J. Invest. Dermatol. 133, 17-26 (2012).

5. Remicade 100 mg powder for concentrate for solution for infusion – Summary of Product Characteristics (SPC). (2014). at https://www.medicines.org.uk/emc/medicine/3236 Last accessed: February 2015.

6. Humira 40 mg solution for injection in pre-filled syringe – Summary of Product Characteristics (SPC). (2014). at https://www.medicines.org.uk/emc/medicine/21201 Last accessed: February 2015.

7. Enbrel 25 mg powder and solvent for solution for injection – Summary of Product Characteristics (SPC). (2014). at https://www.medicines.org.uk/emc/medicine/3343 Last accessed: February 2015.

8. Stelara 45 mg solution for injection – Summary of Product Characteristics (SPC). (2014). at https://www.medicines.org.uk/emc/medicine/23207 Last accessed: February 2015.

9. NICE. CG153 Psoriasis : The assessment and management of psoriasis. 1-3 (2012). at http://publications.nice.org.uk/psoriasis-cg153 Last accessed: February 2015.

10. NICE. Psoriasis is “more than just a skin condition.” (2014). at https://www.nice.org.uk/news/article/psoriasis-is-more-than-just-a-skin-condition Last accessed: February 2015.

11. Takeshita, J. et al. Effect of psoriasis severity on hypertension control: A population-based study in the United Kingdom. JAMA dermatology (2014). doi:10.1001/jamadermatol.2014.2094

12. Farley, E. & Menter, A. Psoriasis: comorbidities and associations. G. Ital. Dermatol. Venereol. 146, 9-15 (2011).

13. Gisondi, P. & Girolomoni, G. Psoriasis and atherothrombotic diseases: disease-specific and non- disease-specific risk factors. Semin. Thromb. Hemost. 35, 313–324 (2009).

14. Kurd, S. K., Troxel, A. B., Crits-Christoph, P. & Gelfand, J. M. The risk of depression, anxiety, and suicidality in patients with psoriasis. Arch Dermatol 146, 891–895 (2010).

15. National Psoriasis Foundation. Psoriasis severity. (2014). at Last accessed: February 2015.

16. Psoriasis Association. About Psoriasis. (2014). at https://www.psoriasis-association.org.uk/pages/view/about-psoriasis Last accessed: February 2015.

17. Bewley, A., Bishop-Bailey, A., Hatchard, C. & Coope, H. PICTURE: A real world study to assess the effectiveness of psoriasis management with biologic therapies in the UK: interim results. 23rd Eur. Acad. Dermatology Venereol. Congr. 1 (2014). at http://eadvamsterdam2014-m.poken.com/event/92466382/product/99155785/description Last accessed: February 2015.

18. Rodgers, M. et al. Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis: a systematic review and economic evaluation. 1-160 (2011).

19. British Association of Dermatologists Biologic Interventions Register Review of 2013. BADBIR 1–2 (2013). at https://www.badbir.org/WebData/Newsletters/2014/January.pdf Last accessed: February 2015.

20. NICE. Secukinumab for treating moderate to severe plaque psoriasis [ID718] | Guidance and guidelines. (2015). at https://www.nice.org.uk/guidance/indevelopment/GID-TAG460 Last accessed: February 2015.

21. Scottish Medicines Consortium. Forthcoming submission: secukinumab (Cosentyx). (2015). at www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/secukinumab_CosentyxLast accessed: February 2015.

Source: Novartis