Novartis Cosentyx® gains EU label update for first-of-its-kind MAXIMISE data in axial manifestations of psoriatic arthritis

Feb 26, 2021
  • Cosentyx® (secukinumab) is the first biologic with proven efficacy in all 6 key manifestations of psoriatic arthritis (PsA), and the only biologic with fast and lasting relief of axial manifestations of PsA in a dedicated trial1,2,3.
  • Up to two-thirds of patients with PsA suffer from axial manifestations4
  • Phase IIIb MAXIMISE trial showed treatment with Cosentyx improved the signs and symptoms of axial manifestations of PsA as early as Week 4; response was maintained up to Week 52, with a consistently favorable safety profile1
  • Cosentyx is an established brand, supported by long-term 5-year sustained efficacy and safety data across psoriasis, PsA and ankylosing spondyloarthritis (AS)2,3,5-7, with 400,000+ patients treated worldwide since launch8

Basel, February 26, 2021 — Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted the final opinion for a type II label variation for Cosentyx® (secukinumab) to include data for axial manifestations of psoriatic arthritis (PsA), from the first-of-its-kind MAXIMISE trial1.

PsA patients with axial manifestations report higher disease burden with higher levels of pain, fatigue, morning stiffness, impairment of physical function, increased enthesitis count and higher levels of inflammatory markers9,10. They also report worse quality of life and/or work productivity11.

Cosentyx is the only fully human interleukin (IL)-17A inhibitor to demonstrate efficacy and safety in a dedicated Phase IIIb study of axial manifestations in PsA1. It is the first biologic with proven efficacy in all six key manifestations of PsA including peripheral disease, enthesitis, dactylitis, skin psoriasis and nail psoriasis2,3.

The label update reinforces Cosentyx leadership in rheumatology and immuno-dermatology, with plans to expand to 10 indications over the next 10 years.

About MAXIMISE
MAXIMISE is a 52-week, double-blind, randomized, placebo-controlled, Phase IIIb study to evaluate the efficacy and safety of Cosentyx® (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The trial included 485 patients with PsA and axial involvement diagnosed by the clinician, with spinal pain rated as >40/100 on a visual analog scale (VAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 despite a trial of at least two non-steroidal anti-inflammatory drugs (NSAIDs). This study consisted of two treatment periods; a placebo-controlled period from baseline to Week 12 (treatment period 1) followed by an active treatment period from Week 12 to Week 52 (treatment period 2). At Week 12, placebo patients were re-randomized to subcutaneous Cosentyx 300 mg or 150 mg. Patients were treated with subcutaneous Cosentyx 300 mg or 150 mg given weekly for 4 weeks and every 4 weeks starting at Week 4. The primary endpoint was the proportion of patients achieving an Assessment of SpondyloArthritis International Society 20 (ASAS20) response with Cosentyx 300 mg at Week 12. The key secondary endpoint was ASAS20 response with Cosentyx 150 mg at Week 12 after superiority of Cosentyx 300 mg was established1.

The trial met both its primary and key secondary endpoints with 62.9% and 66.3% vs 31.3% of patients treated with Cosentyx 300 mg and 150 mg vs. placebo achieving the primary endpoint, respectively. Rapid onset of improvement in the signs and symptoms of axial manifestations of PsA was seen as early as Week 4 and maintained up to Week 52. The safety profile was consistent to previous studies with no new safety signals1.

About Cosentyx® (secukinumab)
Cosentyx is the first and only fully human biologic that directly inhibits interleukin (IL)-17A, a cornerstone cytokine involved in the inflammation and development of moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)13-15. Cosentyx is the only biologic with proven efficacy in all six key manifestations of PsA1-3.

Cosentyx is backed by more than 12 years of clinical experience and long-term five-year data across three indications of psoriasis, PsA and AS, as well as data from real-world evidence16-21. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axial spondyloarthritis, PsA and psoriatic disease, with more than 400,000 patients treated worldwide with Cosentyx since launch8.

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 110,000 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. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2020.
  2. Novartis Pharmaceuticals UK Limited. Cosentyx® (secukinumab): Summary of Product Characteristics [online] December 09, 2020. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: February 2021].
  3. Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020;2(1):18-25.
  4. Feld J, Chandran V, Haroon N, et al. Axial disease in psoriatic arthritis and ankylosing spondylitis: a critical comparison. Nat Rev Rheumatol. 2018;14(6):363-371.
  5. 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: February 2021].
  6. Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019;5:e001005.
  7. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514.
  8. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; October 2020.
  9. Mease PJ, Liu M, Rebello S, et al. Comparative Disease Burden in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis: Data from Two Corrona Registries. Rheumatol Ther. 2019;6(4):529–542.
  10. Mease PJ, Palmer JB, Liu M, et al. Influence of Axial Involvement on Clinical Characteristics of Psoriatic Arthritis: Analysis from the Corrona Psoriatic Arthritis/Spondyloarthritis Registry. J Rheumatol. 2018;45(10):1389-1396.
  11. Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic arthritis: a literature review from a global health systems perspective. P T. 2010;35(12):680-689.
  12. Landewé R, Van Tubergen A. Clinical tools to assess and monitor spondyloarthritis. Curr Rheumatol Rep. 2015;17(7):47.
  13. Girolomoni G, Mrowietz U, Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167(4):717-724.
  14. Sieper J, Poddubnyy D, Miossec P. The IL-23–IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol. 2019;15(12):747-757.
  15. Jansen DT, Hameetman M, van Bergen J, et al. IL-17-producing CD4+ T cells are increased in early, active axial spondyloarthritis including patients without imaging abnormalities. Rheumatology (Oxford). 2015;54(4):728-735.
  16. Data on file. CAIN457F2310 (MEASURE 2): 5-year report. Novartis Pharmaceuticals Corp; September 15, 2015.
  17. Data on file. Data analysis report: study CAIN457A2302E1. Novartis Pharmaceuticals Corp; November 30, 2015.
  18. Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.
  19. Data on file. CAIN457F2312 (FUTURE 2): 5 year-interim report. Novartis Pharmaceuticals Corp; May 2019.
  20. Data on file. CAIN457F2310 (MEASURE 1 and 2): pooled safety data. Novartis Pharmaceuticals Corp; July 23, 2018.
  21. Marzo-Ortega H, Sieper J, Kivitz A. 5-year efficacy and safety of secukinumab in patients with ankylosing spondylitis: end-of-study results from the phase 3 MEASURE 2 trial. Lancet Rheumatol. 2020;2(6):e339-e346.

# # #

Novartis Media Relations
E-mail: [email protected]

Michael Meo
Novartis Global 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 7944Sloan Simpson+1 862 778 5052
Thomas Hungerbuehler    +41 61 324 8425  
Isabella Zinck+41 61 324 7188