New Cosentyx® (secukinumab) label to include 300 mg up-titration option is informed by results from the Phase III MEASURE 3 study
Approval provides clinicians with greater choice for their patients, based on clinical response to treatment
News follows recent announcement of submission to EMA for new indication for non-radiographic axial spondyloarthritis (nr-axSpA), potentially providing patients with a treatment that addresses the complete axSpA disease spectrum
Cosentyx is an established brand supported by 5-year sustained efficacy and safety data across psoriatic arthritis, ankylosing spondylitis and psoriasis, with over 250,000 patients treated worldwide-
Basel, October 24, 2019 – Novartis, a leader in rheumatology and immuno-dermatology, announced today that the European Commission (EC) has approved a label update for the up-titration of Cosentyx (secukinumab) to 300 mg for patients with active ankylosing spondylitis (AS).
The approval is based on data from MEASURE 3, a three-year study that explored the tolerability and efficacy of Cosentyx in patients with AS. Response rates were greater in the 300 mg dose group, particularly among patients with previous anti-TNF exposure, compared with the recommended 150 mg dose. The safety profile was consistent with previous studies.
“This approval gives rheumatologists more flexibility to ensure their patients are able to achieve the best response to treatment,” said Sam Khalil, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “It further encourages our ongoing efforts to reimagine care to ensure all patients are able to experience full relief from the signs and symptoms of AS.”
About axSpA Axial spondyloarthritis (axSpA) is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain. The axSpA disease spectrum includes ankylosing spondylitis (AS), in which joint damage is visible on x-ray, and non-radiographic axial spondyloarthritis (nr-axSpA), in which joint damage is not visible on x-ray. Both parts of the disease spectrum have a comparable symptom burden, including nocturnal pain, fatigue, morning stiffness and functional disability. If left untreated, axSpA can impair activity, lead to lost work time, and have a significant impact on quality of life.
About Cosentyx (secukinumab) Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation and development of psoriatic arthritis (PsA), psoriasis (PsO), and ankylosing spondylitis (AS),.
Cosentyx is backed by robust clinical evidence, including 5-year data across PsO, PsA and AS, as well as data from real world evidence-. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axSpA, PsA, and psoriatic disease, with more than 250,000 patients treated worldwide with Cosentyx since its launcj.
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References  ClinicalTrials.gov. 16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients (MEASURE 3). Available from: https://clinicaltrials.gov/ct2/show/NCT02008916. Last accessed: October 2019.  Novartis press release. Novartis Cosentyx® positive 16-week PREVENT results advance potential new indication for patients with axial spondyloarthritis. Available from: https://www.novartis.com/news/media-releases/novartis-cosentyx-positive-16-week-prevent-results-advance-potential-new-indication-patients-axial-spondyloarthritis. Last accessed: October 2019.  ClinicalTrials.gov. Search of: secukinumab, recruiting, not yet recruiting, active, not recruiting, completed, enrolling by invitation studies. Listed results on ClinicalTrials.gov [online]. Available from: https://clinicaltrials.gov/ct2/results?term=secukinumab&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&recrs=e&age_v=&gndr=&type=&rslt= [Last accessed: October 2019].  ClinicalTrials.gov. Comparison of Secukinumab versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab (ARROW). NCT03553823. Available from: https://clinicaltrials.gov/ct2/show/NCT03553823 [Last accessed: October 2019].  Langley RG, et al. Secukinumab in plaque psoriasis—results of two phase 3 trials. N Engl J Med 2014;371:326–338.  Bagel J, et al. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther 2018;8:571–579.  ClinicalTrials.gov. Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as compared to GP2017 (Adalimumab Biosimilar) (SURPASS). NCT03259074. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03259074 [Last accessed: October 2019].  Blauvelt A, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol 2017;76:60–69.  Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Presented as eposter P2223 at 26th EADV Congress 2017. 13th October 2017.  Mease PJ, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5 Year Efficacy and Safety Results from a Phase 3 Trial. Abstract presented at the American College of Rheumatology Annual Meeting, 2018.  MEASURE 2. Novartis data on file.  Holdsworth E et al. Real world physician satisfaction with secukinumab in Psoriatic Arthritis and Ankylosing Spondylitis in Europe. Presented at EULAR 2019.  Michelsen B et al. Remission and drug retention rates of secukinumab in 1549 patients with psoriatic arthritis treated in routine care – pooled data from the observational EuroSpA Research Collaboration Network. Presented at EULAR 2019.  Michelsen B et al. Pooled 6-month treatment outcomes and drug retention rates in 1556 patients with axial spondyloarthritis treated with secukinumab in routine clinical practice in 12 European Countries in the EuroSpA Research Collaboration. Presented at EULAR 2019.  Baraliakos X et al. Long-term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial. Presented as a late-breaking abstract at the American College of Rheumatology Annual Meeting, 2018.  Strand V, et al. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct; 23(7): 383–391.  Mease PJ, van der Heijde D, Karki C, et al. Characterization of patients with ankylosing spondylitis and nonradiographic axial spondyloarthritis in the US-based Corrona Registry. Arthritis Care Res (Hoboken). 2018;70(11):1661-1670.  Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf. Last accessed: October 2019.  Girolomoni G, et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167:717–724.  Novartis data on file. September 2019.