Prescribing information

 

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The first and only fully human IL-17A inhibitor:1

 

 Image of the number 250,000 plus

Cosentyx patients treated since launch2*

 
 Image of the words '100 clinical trials'

with Cosentyx over 10+ years, including FUTURE 5, the largest randomised, controlled trial to date of a biologic in PsA3,4

 
 Image of the words 'Recommended by NICE'

for first-line biologic treatment of PsA and AS5,6‡

 

Helping your patients LOOK BETTER, MOVE BETTER, FEEL BETTER7–11

GIF frame 1: Look better, fast and sustained skin clearance in moderate to severe PsO GIF frame 2: Move better, sustained efficacy in PsA and AS GIF frame 3: Feel better, quality of life improvement rates were sustained up to 5 years

*Worldwide, across all licensed indications.2

Not limited to licensed indications.3,4

Cosentyx is recommended, within its marketing authorisation, as an option for treating active AS in adults whose disease has responded inadequately to conventional therapy (non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors).5
Cosentyx alone, or in combination with MTX, is recommended as an option for treating active PsA in adults only if: it is used as described in the NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of PsA or the person has had a TNF-alpha inhibitor but their disease has not responded within the first 12 weeks or has stopped responding after 12 weeks or TNF-alpha inhibitors are contraindicated but would otherwise be considered.6

§n=167. CLEAR study: Efficacy data reported as non-responder imputation in patients with moderate to severe psoriasis. Primary endpoint was met: Superiority of secukinumab to ustekinumab in achieving PASI 90 response at week 16 in overall patient population (P<0.0001).7

n=122. Patients with moderate to severe plaque psoriasis, who completed 52 weeks of the SCULPTURE study, could enter this extension study, which was double-blind until Year 3, and thereafter was unblinded to Year 5. Efficacy data were reported as observed; no P values were reported.8

#n=53/74 and n=39/74 respectively. FUTURE 1: Primary endpoint was met: ACR 20 response at week 24, in overall patient population (P<0.001).13 Those patients who completed the 2-year core trial entered the 3-year extension study (N=236). Efficacy data were reported as observed.10

**n=59/76. MEASURE 1: Primary endpoint was met: ASAS 20 response rate at Week 16 in the overall patient population (P<0.001).14 Those patients who completed the 2-year core trial entered the 3-year extension study (N=274). Efficacy data were reported as observed.11

ACR, American College of Rheumatology criteria; AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis international Society; DMARD, disease-modifying anti-rheumatic drug; IL, interleukin; MTX, methotrexate; PASI, psoriasis area severity index; PsA, psoriatic arthritis; PsO, plaque psoriasis; QoL, quality of life; TNF, tumour necrosis factor.

References

  1. Cosentyx Summary of Product Characteristics.
  2. Rheumatology DOF UK 244.
  3. Novartis real-world evidence confirms efficacy and safety benefits of Cosentyx in daily life for psoriasis patients [press release]. Basel, Switzerland. 13 September 2018. Available at: https://www.novartis.com/news/media-releases/novartis-real-world-evidence-confirms-efficacy-and-safety-benefits-cosentyx-daily-life-psoriasis-patients.
  4. Mease P et al. Ann Rheum Dis 2018;77:890–897.
  5. NICE technology appraisal TA 407. Available at: https://www.nice.org.uk/guidance/TA407 (accessed April 2020).
  6. NICE technology appraisal TA 445. Available at: https://www.nice.org.uk/guidance/ta445 (accessed April 2020).
  7. Thaci D et al. J Am Acad Dermatol 2015;7(3):400–409.
  8. Bissonnette R et al. J Eur Acad Dermatol Venereol 2018;32:1507–1514.
  9. Langley RG et al. N Engl J Med 2014;371(4):326–338.
  10. Mease PJ et al. ACR Open Rheumatology 2020;2(1):18–25.
  11. Baraliakos X et al. RMD Open 2019;5:e001005.
  12. Rheumatology DOF UK 215.
  13. Mease PJ et al. N Engl J Med 2015;373(14):1329–1339.
  14. Baeten D et al. N Engl J Med 2015;373(26):2534–2548.
COS20-C014 May 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]