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Novartis PREVENT data show Cosentyx® helps patients realize early and lasting relief in axial spondyloarthritis

• Phase III PREVENT data show Cosentyx® 150 mg provided significant and sustained improvement in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) up to Week 521

• nr-axSpA is the fourth EU indication for Cosentyx, providing patients in Europe with a first-in-class treatment that addresses the axial spondyloarthritis (axSpA) disease spectrum

• There are approximately 1.7 million patients with nr-axSpA in the top five EU countries and US2

• PREVENT is the largest ever study of a biologic in patients with nr-axSpA; data reinforce Cosentyx leadership in rheumatology and immuno-dermatology

Novartis, a leader in rheumatology and immuno-dermatology, today announced the full 52-week results from the Phase III PREVENT trial, which reinforce the substantial and sustained benefits of Cosentyx® (secukinumab) across the axial spondyloarthritis (axSpA) spectrum.

The study found patients treated with Cosentyx 150 mg showed significant and sustained improvements in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) at 52 weeks. nr-axSpA is a painful and debilitating condition affecting 1.7 million people in the top five EU countries and the US2. However, because nr-axSpA is underdiagnosed, with an average delay in diagnosis of more than seven years, that number may be higher3.

“Axial spondyloarthritis can have a serious impact on a patient’s quality of life and ability to carry out everyday tasks. PREVENT demonstrated the efficacy and safety of secukinumab in non-radiographic axial spondyloarthritis, showing early and sustained relief from the signs and symptoms of this often painful disease,” said Jürgen Braun, MD, Professor of Rheumatology at Ruhr-University Bochum, Germany, and an investigator in the secukinumab clinical trial program.

The PREVENT trial met its primary endpoint of 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40) in biologic treatment-naïve patients at Week 16 and Week 52 versus placebo (41.5% vs 29.2%: P<0.05 and 35.4% vs 19.9%: P<0.05), respectively when a loading dose was used.

Secondary endpoints indicating improvements in pain, mobility and health-related quality of life were also met in the trial up to Week 52. The trial demonstrated a safety profile consistent with previous clinical trials with no new safety signals reported1. The PREVENT data are being presented at the Annual European Congress of Rheumatology (EULAR) e-congress 2020.

“With these new data and the recent first-in-class European approval of Cosentyx in non-radiographic axial spondyloarthritis, we are continuing to build on our heritage in the axial spondyloarthritis disease spectrum,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology & Dermatology at Novartis. “This fourth indication for Cosentyx further demonstrates our commitment to reimagine care for more patients.”

Cosentyx is the first fully-human interleukin (IL)-17A inhibitor indicated for patients in Europe with nr-axSpA and is backed by five years of clinical data supporting long-term safety and efficacy across moderate-to-severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

In April 2020, Novartis received approval of Cosentyx from the European Commission for the treatment of nr-axSpA4. Novartis has also submitted Cosentyx for review by the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with nr-axSpA.

About axSpA

AxSpA is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain5. The axSpA spectrum includes AS, in which joint damage is generally visible on X-ray, and nr-axSpA, in which joint damage is not visible on X-ray5,6.

Both parts of the disease spectrum have a comparable symptom burden, including nocturnal waking caused by pain, spinal pain, morning stiffness, fatigue and functional disability7. If left untreated, axSpA impairs activity, leads to lost work time and has a significant impact on quality of life, including family relationships7.

About Cosentyx

Cosentyx is the first and only fully-human biologic that directly inhibits IL-17A, a cornerstone cytokine involved in the inflammation and development of PsO, PsA and AS8-11.

Cosentyx is backed by robust clinical evidence, including five-year data across three indications of PsO, PsA and AS, as well as data from real world evidence12-14. 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 300,000 patients treated worldwide with Cosentyx since launch15.

About PREVENT

PREVENT is an ongoing two-year randomized, double-blind, placebo-controlled Phase III study (with a two-year extension phase) to investigate the efficacy and safety of Cosentyx in patients with active nr-axSpA. The study enrolled 555 male and female adult patients with active nr-axSpA (with onset before 45 years of age, spinal pain rated as >=40/100 on a visual analog scale (VAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4) and who had been taking at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at the highest dose up to 4 weeks prior to study start.

Patients may have previously taken a TNF inhibitor (not more than one) but had an inadequate response. Of the 555 patients enrolled in the study, 501 (90.3%) were biologic-naïve. Patients were allocated to one of three treatment groups: Cosentyx 150 mg subcutaneously with loading dose (induction: 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance with 150 mg secukinumab monthly); Cosentyx 150 mg no loading dose (150 mg secukinumab subcutaneously monthly), or placebo (induction of subcutaneously weekly for 4 weeks, followed by maintenance of once-monthly).

The primary endpoints are the proportion of patients achieving an ASAS40 response with Cosentyx 150 mg at Weeks 16 and 52 in TNF-naive patients. Secondary endpoints include among others change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP)1.

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,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “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, 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 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.

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References

  1. Braun J, Blanco R, Dokoupilova E, et al. Secukinumab 150 mg Significantly Improved Signs and Symptoms of Non-radiographic Axial Spondyloarthritis: 52-week Results from the Phase III PREVENT Study. Abstract OP0106 presented at EULAR e-congress 2020.
  2. DRG Epidemiology Database. Axial Spondyloarthritis: Disease Landscape & Forecast [online] August 2019. Available from: https://decisionresourcesgroup.com/report/716950-biopharma-axial-spondyloarthritis-landscape-forecast/ [Last accessed: May 2020].
  3. Garrido-Cumbrera M, Poddubnyy D, Gossec L, et al. The European Map of Axial Spondyloarthritis: Capturing the Patient Perspective—an Analysis of 2846 Patients Across 13 Countries. Current Rheumatology Reports. 2019; 21:19.
  4. Novartis press release. Novartis Cosentyx® gains fourth indication in EU with first-in-class approval in axial spondyloarthritis spectrum [online]. Available from: https://www.novartis.com/news/media-releases/novartis-cosentyx-gains-fourth-indication-eu-first-class-approval-axial-spondyloarthritis-spectrum [Last accessed: May 2020].
  5. Strand V and Singh JA. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017;23:383-91.
  6. Rudwaleit M, van der Heijde D, Landewe R, et al. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009;68:777-83.
  7. Mease PJ, van der Heijde D, Karki C, et al. Characterization of patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis in the US-based Corrona Registry. Arthritis Care Res (Hoboken). 2018;70:1661-70.
  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: May 2020].
  9. Girolomoni G, Mrowietz U, Paul C, et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.
  10. Sieper J, Poddubnyy D, Miossec P. The IL-23–IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol. 2019;15:747-57.
  11. Brembilla NC, Senra L, Boehncke W-H. The IL-17 Family of Cytokines in Psoriasis: IL-17A and Beyond. Front. Immunol. 2018;9:1682.
  12. Bissonnette R, Luger T, Thaci D, et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. J Eur Acad Dermatol Venereol. 2018;32:1507-14.
  13. 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; 2:18-25.
  14. Deodhar A, Blanco R, Dokoupilova E, et al. Secukinumab 150 mg Significantly Improved Signs and Symptoms of Non-radiographic Axial Spondyloarthritis: Results from a Phase 3 Double-blind, Randomized, Placebo-controlled Study. Abstract presented at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals; Nov 8–13 2019; Atlanta, GA.

Antonio Ligi