New data reinforce efficacy and convenience of Novartis Cosentyx® (secukinumab) 300 mg autoinjector in adults with psoriasis

New data reinforce efficacy and convenience of Novartis Cosentyx® (secukinumab) 300 mg autoinjector in adults with psoriasis

• New findings show Cosentyx^® (secukinumab) 300 mg single dose autoinjector (the UnoReady^® pen) resulted in superior efficacy vs placebo¹

• Patient satisfaction with 300 mg autoinjector was high – reaching 100% – with no new safety signals observed over 52 weeks¹

• Cosentyx is a proven medicine supported by sustained efficacy and safety data across several systemic inflammatory conditions^2-6, with more than 500,000 patients treated worldwide since launch⁷

Basel, September 29, 2021 — Novartis, a leader in immuno-dermatology and rheumatology, today announced data from an international Phase IIIb study, which showed treatment with Cosentyx^® (secukinumab) 300 mg in a 2 mL autoinjector (UnoReady^® pen) resulted in high efficacy and convenient administration in adults with moderate to severe plaque psoriasis¹. These data were presented at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress.

“Chronic diseases like psoriasis can often be difficult to manage and adherence to treatments can be a challenge for patients,” said Professor Bardur Sigurgeirsson, University of Iceland, lead author of the MATURE study. “This study shows that a 300 mg dose of Cosentyx can be delivered in one injection, making it more convenient and simpler for patients to use, without compromising efficacy or safety.”

The MATURE study assessed the use of a Cosentyx 300 mg autoinjector, versus two 150 mg pre-filled syringes or placebo. Patients using the 300 mg autoinjector reported significantly improved skin clearance measured by Psoriasis Area and Severity Index (PASI) 75 and 90 versus placebo.

“We’re always looking for ways to improve usability and adherence of all our therapies, so people get the most benefit and treatments are convenient to administer. With the Cosentyx 300 mg autoinjector, people with psoriasis can better manage their symptoms with fewer injections. It’s great to know that all adults who trialed the Cosentyx UnoReady autoinjector said they were satisfied with how it worked,” said Todd Fox, Global Head of Medical Affairs for Immunology, Hepatology and Dermatology, Novartis.

The study showed high patient satisfaction, with 100% of those in the Cosentyx 300 mg UnoReady group reporting they were “very satisfied” or “satisfied” at Week 28. The safety profile reported was consistent with previous studies, and no new safety signals were observed¹.

The UnoReady pen was approved for use in Europe in November 2020 for all patients requiring a 300 mg dose of Cosentyx. Cosentyx is approved in over 100 countries at doses up to 300 mg for adults with moderate to severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis⁸.

Lay summaries of the MATURE study and other key abstracts presented at EADV 2021 are available from the Novartis website: https://www.novartis.com/our-focus/immunology-dermatology/abstract-summaries-eadv.

About the MATURE study

MATURE was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb study conducted at 22 sites worldwide, with 122 patients randomized. The study consisted of three periods: screening (screening to baseline [BL]), treatment period 1 (BL to Week 12; pre dose), and treatment period 2 (Week 12 dose to Week 52). Eligible patients were randomized to receive secukinumab 300 mg in a 2 mL autoinjector or two 150 mg in 1 mL pre-filled syringes or placebo. The co-primary endpoints were Psoriasis Area and Severity Index (PASI) 75 and Investigator’s Global Assessment (IGA) modified 2011 0/1 responses at Week 12. The key secondary endpoint was PASI 90 response at Week 12. Other secondary endpoints were pharmacokinetic assessments, PASI 75/90/100 responses, Dermatology Life Quality Index (DLQI) score of 0/1, usability of 2 mL autoinjector (rated through a Self-Injection Assessment Questionnaire [SIAQ]), and safety over a period of 52 weeks⁹.

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References

1. Sigurgeirsson B, Browning J, Tyring S, et al. High efficacy, safety, and tolerability of secukinumab injection with 2 mL auto-injector (300 mg) in adult patients with moderate to severe plaque psoriasis: 52-week results from MATURE, a randomised, placebo-controlled trial. Presented at EADV 30th Annual Congress 2021. Abstract A2325.
2. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014;371:326-338.
3. Mease PJ, McInnes IB, Kirkham B, et al. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015;373:1329-1339.
4. McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386:1137-1146.
5. Baeten D, Sieper J, Braun J, et al. Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis. N Engl J Med. 2015;373:2534-2548.
6. Deodhar A, Blanco R, Dokoupilova E, et al. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021;73:110-120.
7. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; June 2021.
8. 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: September 2021].
9. Clinical Trials.gov. Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis (MATURE). NCT03589885. Available from: https://clinicaltrials.gov/ct2/show/NCT03589885 [Last accessed: September 2021].