Novartis Announces Study Data Demonstrating Cosentyx Reduced Signs and Symptoms of Psoriatic Arthritis While Inhibiting Progression of Joint Structural Damage

EAST HANOVER, N.J., Nov. 7, 2017 /PRNewswire/ -- Novartis announced today results from the FUTURE 5 study showing Cosentyx^® (secukinumab) reduced the signs and symptoms of psoriatic arthritis (PsA) while significantly inhibiting the progression of joint structural damage in PsA patients compared to placebo at 24 weeks. The Phase III data were presented for the first time today as a late breaker during the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Diego.

PsA is estimated to affect up to 2 million people in the US and is characterized by joint pain and stiffness.²

Study participants (n=996) were randomized to receive Cosentyx, 300 mg with loading dosage (LD), 150 mg with LD, 150 mg without LD, or placebo. At week 24, more participants treated with Cosentyx had no worsening of joint structural damage compared to placebo, as measured by the modified total van der Heijde Sharp score (mTSS) <=0.5; 88% (300 mg), 80% (150 mg), 84% (150 mg without LD), and 74% (placebo).¹ mTSS is a detailed scoring method evaluating erosion in the joints.³

"People living with psoriatic arthritis deal with the daily impact of pain, tender joints, as well as the potential of reduced mobility, and irreversible joint damage," said Philip Mease, MD, director of the Rheumatology Clinical Research Division of Swedish Medical Center and lead study investigator and clinical professor at the University of Washington School of Medicine in Seattle. "A treatment that reduces the signs and symptoms of psoriatic arthritis and addresses the disease on a structural level by slowing the progression of joint damage could offer a significant benefit for patients."

Participants taking Cosentyx achieved significant improvements in the signs and symptoms of PsA compared to placebo, as measured by the ACR response criteria (ACR20) at 16 weeks, the study's primary endpoint.¹ ACR is a standard tool used to assess improvement of PsA signs and symptoms such as tender and swollen joints, pain and physical functioning. The number of ACR20 responders at week 16 were 62% (300 mg, P < 0.0001), 55% (150 mg, P < 0.0001), 59% (150 mg without LD, P < 0.0001), and 27% (placebo).¹

"With nearly 1,000 patients included in the study, FUTURE 5 is the largest randomized controlled trial of a biologic conducted to date in psoriatic arthritis," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "The results are encouraging as they provide important information about the ability of Cosentyx to address key areas of concern for physicians when managing the symptoms and the underlying progression of joint structural damage of psoriatic arthritis."

All hierarchical endpoints were significant for Cosentyx versus placebo at week 16 for all treatment arms, except for the 150 mg without LD in resolving enthesitis (tenderness or pain often occurring in the bottom of the foot, heel or elbow) and dactylitis (sausage-like swelling in the fingers or toes).^1,2 Further, efficacy across all endpoints was greater in patients who had not been previously treated with anti-TNF therapies.¹ Participants taking the 300 mg and 150 mg dosages with LD had an earlier onset of response versus participants who received 150 mg without LD.¹

The safety profile was consistent with that observed in previous studies and similar across arms, with no new adverse events (AEs) identified.^1,4 The most common AEs at week 16 were upper respiratory tract infection, headache, hypertension, and urinary tract infection.⁴

About the FUTURE 5 study (NCT02404350)¹
In the study, participants (n=996) with active PsA were randomized to receive Cosentyx 300 mg with LD, 150 mg with LD, 150 mg without LD, or placebo. All groups received Cosentyx or placebo at baseline (BL), weeks 1, 2, 3, and 4, and then every 4 weeks. At week 16, placebo non-responders (patients with <20% improvement from BL in tender or swollen joint counts) were switched to Cosentyx 300 mg or 150 mg; remaining placebo patients were switched at week 24. The primary endpoint was ACR20 at week 16 and the key secondary endpoint was radiographic structural progression, as measured by mTSS, assessed by two blinded readers, based on hand/wrist/foot X-rays obtained at BL, week 16 (non-responders), and week 24.

With nearly 1,000 patients included in the Phase III study, FUTURE 5 is the largest randomized controlled trial (RCT) of a biologic conducted to date in PsA.

About psoriatic arthritis (PsA)
Closely associated with psoriasis, psoriatic arthritis (PsA) is part of a spectrum of long-term diseases impacting joints, known as spondyloarthritis (SpA).⁵ Up to 2 million people are currently diagnosed with PsA in the US and approximately one in four of people with psoriasis may have undiagnosed PsA.^2,6 Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers and persistent painful tendonitis.² PsA can lead to irreversible joint damage and disability caused by years of inflammation.⁷ Up to 40% of PsA patients can suffer from joint destruction and permanent physical deformity.⁸

About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.⁹

Cosentyx is the only IL-17a approved for the treatment of active ankylosing spondylitis and PsA. Cosentyx is approved in more than 70 countries, which includes the European Union countries and the US. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan.¹⁰

In addition, Cosentyx is approved in more than 75 countries for the treatment of moderate to severe plaque psoriasis, which includes the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Cosentyx is approved for the first-line systemic treatment of moderate to severe plaque psoriasis in adult patients.¹¹ In the US, Cosentyx is approved as a treatment for moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).¹²

To date, more than 100,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications.¹³ In addition, 2017 marks 10 years since the first patient visit in a clinical trial with Cosentyx.¹³

INDICATIONS

Cosentyx is a human interleukin-17A antagonist indicated for the treatment of:

• moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy
• adults with active psoriatic arthritis (PsA)
• adults with active ankylosing spondylitis (AS)

IMPORTANT SAFETY INFORMATION

Do not use Cosentyx if you have had a severe allergic reaction to secukinumab or any of the other ingredients in Cosentyx. See the Medication Guide for a complete list of ingredients.

Cosentyx is a medicine that affects your immune system. Cosentyx may increase your risk of having serious side effects such as:

Infections

Cosentyx may lower the ability of your immune system to fight infections and may increase your risk of infections.

• Your doctor should check you for tuberculosis (TB) before starting treatment with Cosentyx.
• If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Cosentyx and during treatment with Cosentyx.
• Your doctor should watch you closely for signs and symptoms of TB during treatment with Cosentyx. Do not take Cosentyx if you have an active TB infection.

Before starting Cosentyx, tell your doctor if you:

• are being treated for an infection
• have an infection that does not go away or that keeps coming back
• have TB or have been in close contact with someone with TB
• think you have an infection or have symptoms of an infection such as:

                -fevers, sweats, or          -warm, red, or painful
                chills                       skin or

               -  muscle aches                sores on your body

               - cough                       -diarrhea or stomach
                                             pain

               - shortness of breath         -burning when you
                                             urinate

               - blood in your phlegm         or urinate more often
                                               than

               - weight loss                  normal

After starting Cosentyx, call your doctor right away if you have any signs of infection listed above. Do not use Cosentyx if you have any signs of infection unless you are instructed to by your doctor.

Inflammatory Bowel Disease

New cases of inflammatory bowel disease or "flare-ups" can happen with Cosentyx, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your doctor if you have worsening disease symptoms during treatment with Cosentyx or develop new symptoms of stomach pain or diarrhea.

Serious Allergic Reactions

Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; or skin rash. If you have a severe allergic reaction, do not give another injection of Cosentyx.

Before starting Cosentyx, tell your doctor if you:

• have any of the conditions or symptoms listed above for infections
• have inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• are allergic to latex. The needle caps contain latex.
• have recently received or are scheduled to receive an immunization (vaccine). People who take Cosentyx should not receive live vaccines.
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Cosentyx can harm your unborn baby. You and your doctor should decide if you will use Cosentyx.
• are breastfeeding or plan to breastfeed. It is not known if Cosentyx passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

How should I use Cosentyx?

See the detailed Instructions for Use that comes with your Cosentyx for information on how to prepare and inject a dose of Cosentyx, and how to properly throw away (dispose of) used Cosentyx Sensoready® pens and prefilled syringes.

• Use Cosentyx exactly as prescribed by your doctor.
• If your doctor decides that you or a caregiver may give your injections of Cosentyx at home, you should receive training on the right way to prepare and inject Cosentyx. Do not try to inject Cosentyx yourself, until you or your caregiver has been shown how to inject Cosentyx by your doctor or nurse.

The most common side effects of Cosentyx include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of Cosentyx. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information, including Medication Guide.

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; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, 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
Located in East Hanover, NJ Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 121,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

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References

1. Mease, PJ et al. Subcutaneous Secukinumab Inhibits Radiographic Progression in Psoriatic Arthritis: Primary Results from a Large Randomized, Controlled, Double-Blind Phase 3 Study. Presented as a late-breaker at the Annual Meeting of the American College of Rheumatology. November 7, 2017.
2. National Psoriasis Foundation. Media Kit. Available at: https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Last accessed October 2017.
3. van der Heijde, D. Psoriatic arthritis imaging: a review of scoring methods. BMJ. 2005; 64(Suppl II):ii61-ii64. doi: 10.1136.
4. Data on File. CAIN457F2342 (FUTURE 5) Data Analysis Report. Novartis Pharmaceuticals Corp; Sept 2017
5. Spondylarthritis (Spondylarthropathy). American College of Rheumatology (ACR) Web site. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Spondyloarthritis. Accessed October 2017.
6. Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005; 64:ii14-ii17.
7. Villani AP, Rouzaud M, Sevrain M, et al. Prevalence of undiagnosed psoriatic arthritis among psoriasis patients: Systematic review and meta-analysis. J Am Acad Dermatol. 2015;73(2):242-8.
8. Mease P, Goffe BS. Diagnosis and treatment of psoriatic arthritis. J Am Acad Dermatol 2005; 52(1):1-19
9. Mease, PJ, McInnes, IB, 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. The Lancet. 2015; 386, No. 9999; p1137-1146.
10. Pharmaceuticals and Medical Devices Agency. Review Report. Available at: http://www.pmda.go.jp/files/000216877.pdf . Accessed August 10, 2017.
11. Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Last accessed August 2017.
12. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2017
13. Novartis Data on file. Number of Patients Prescribed Cosentyx. May 2017.

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