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

Sep 29, 2021
  • 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 conditions2-6, 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.

Disclaimer
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.


About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews.
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library.
For questions about the site or required registration, please contact [email protected].

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].

###
  

Novartis Media Relations
E-mail: [email protected]

Michael Meo
Novartis US External Communications
+1 862 274 5414 (direct)
[email protected]

 

Julie Masow
Novartis US External Communications
+1 862 579 8456
[email protected]
Louise Clark
Novartis Pharma Communications
+41 61 324 2970 (direct)
[email protected]

 

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: [email protected]

Central   North America  
Samir Shah +41 61 324 7944 Sloan Simpson +1 862 345 4440
Thomas Hungerbuehler +41 61 324 8425 Alina Levchuk +1 862 778 3372
Isabella Zinck +41 61 324 7188 Parag Mahanti +1 973 876 4912