Novartis Cosentyx® first to show efficacy in all key manifestations of psoriatic arthritis

• First-of-its-kind data shows efficacy and safety of a biologic in the management of axial manifestations of psoriatic arthritis (PsA), which affect up to an estimated 35 million people worldwide[1]
   
• 66.3% of patients treated with secukinumab 150 mg achieved rapid and significant improvements in the signs and symptoms of psoriatic arthritis with axial manifestations at Week 12
   
• Cosentyx bridges for the first time treatment of psoriasis, psoriatic arthritis and axial manifestations
   
• Results strengthen unique position of Cosentyx as a rapid, comprehensive treatment of spondyloarthritis and psoriatic disease, with over 200,000 patients treated worldwide

Basel, June 12, 2019 - Novartis, a leader in rheumatology and immuno-dermatology, today announced new data from the MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA).

The ongoing 52-week Phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300 mg and 66.3% of Cosentyx 150 mg patients achieving ASAS20 at Week 12 (versus 31.3% for placebo) respectively. Rapid onset of relief was seen as early as week four, with the trial demonstrating a favorable safety profile consistent with previous clinical trials[2].

"Up to two thirds of patients with psoriatic arthritis experience inflammatory back pain, which can limit mobility," said Dr. Laura Coates, NIHR Clinician Scientist and Senior Clinical Research Fellow at Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK. "This study provides clinicians with the evidence to help them choose a comprehensive treatment for psoriatic arthritis that addresses diverse patient phenotypes."

PsA is a complex disease with multiple manifestations driving patient symptoms[3],[4]. It is estimated to affect up to 50 million people wordwide[5-8] and is part of a family of long-term inflammatory diseases (spondyloarthritis) that target the joints. It is closely associated with psoriasis; up to 40% of patients with psoriasis have PsA[6].

"This is the first time we've seen the efficacy of a biologic in the axial manifestations of psoriatic arthritis at 12 weeks," said Dr. Antonio Mera Varela, Head of Rheumatology, Hospital Clínico Universitario de Santiago de Compostela, Spain. "As a physician, it's highly important that there is something that can help manage all aspects of my patients' psoriatic arthritis, including inflammation of the spine, joints, enthesitis, dactylitis and psoriasis of the skin and nails."

These data, which add to the existing evidence supporting Cosentyx as a treatment across multiple psoriatic disease manifestations, will be presented at the Annual European Congress of Rheumatology (EULAR) on 12-15 June in Madrid, Spain.

About MAXIMISE
MAXIMISE is a 52-week, double-blind, randomized, placebo-controlled Phase IIIb study to evaluate the efficacy and safety of Cosentyx in the management of axial manifestations of PsA. MAXIMISE enrolled 498 patients with PsA, clinician-diagnosed axial involvements, spinal pain rated as >40/100 on a visual analog scale (VAS) and BASDAI >4 despite trial of at least two non-steroid anti-inflammatory drugs. Patients were treated with subcutaneous Cosentyx 300 mg or 150 mg given weekly for 4 weeks and every 4 weeks thereafter. The primary endpoint was the proportion of patients achieving an 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 established. At Week 12, placebo patients were re-randomized to subcutaneous Cosentyx 300 mg or 150 mg².

ASAS20 is achieved when there is a measure of an improvement of at least 20% and an improvement of at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), and Inflammation[9].

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 PsA, psoriasis (PsO), and ankylosing spondylitis (AS)[10].

Cosentyx is backed by robust clinical evidence, including dedicated studies in the persistent manifestations of psoriasis, namely nails, scalp, palms and soles, as well as PsA and AS[11-13]. Cosentyx has shown long-lasting efficacy and a favorable safety profile while addressing psoriatic disease, therefore offering a complete treatment[13]. It has shown sustained safety and long-lasting efficacy in three 5-year Phase III extension studies in PsO, PsA and AS[12-14].^,13, Today, more than 200,000 patients worldwide have been treated with Cosentyx since launch[15].

Disclaimer
This press release 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," "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 press release, 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 press release 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 and economic conditions; safety, quality 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 press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release 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 more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 105,000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.

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References

[1]    Field J. et al. What Is Axial Psoriatic Arthritis? Rheum Rev. 2018; 14:363

[2]    Braliakos X. et al. OP0235 Secukinumab improves axial manifestations in patients with psoriatic arthritis and inadequate response to NSAIDS: primary analysis of the MAXIMISE trial. Presented at the annual European League Against Rheumatism (EULAR) 2019.

[3]    Ritchin CT et al. Psoriatic Arthritis. N Engl J Med. 2017; 376(10): 957-970.

[4]    Kavanaugh A et al. Psoriatic Arthritis and Burden of Disease: Patient Perspectives from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Rheumotol Ther. 2016; 3(1); 91-102.

[5]    Statistics. National Psoriasis Foundation. Available at: https://www.psoriasis.org/content/statistics. Last accessed: May 2019.

[6]    Mease PJ et al. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs 2014;74:423-41.

[7]    Liu J.T et al. Psoriatic arthritis: Epidemiology, diagnosis, and treatment. World JOrthop. 2014; 5(4): 537-543. 

[8]    Scotti L et al. Prevalence and incidence of psoriatic arthritis: A systematic review and meta-analysis. Science Direct. 2018;48:28-34.

[9]    Landewe R and Van Tubergen A. Clinical tools to assess and monitor spondyloarthritis. Curr Rhen Rep 2015;17(7):47

[10]  Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: http://www.ema.europa.eu/ema/index.jsp? curl=pages/medicines/human/medicines/003729/human_med_ 001832.jsp&mid=WC0b01ac058001d124 [Last accessed: May 2019].

[11]  Reich, K et al. Secukinumab Shows Sustained Efficacy in Difficult-to-Treat Palmoplantar, Nail, and Scalp Psoriasis: Long-term Results From 3 Phase III Placebo-Controlled Randomized Trials. Presented as a Late Breaking Poster #6 at the 3rd Inflammatory Skin Disease Summit (ISDS), Vienna. December 2018.

[12]  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.

[13]  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.

[14]  Bissonnette, R et al. Secukinumab Demonstrates High Sustained Efficacy and a Favorable Safety Profile in Patients with Moderate to Severe Psoriasis through 5 Years of Treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32: 1507-1514

[15]  Novartis, data on file. May 2019

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