Approximately 80% of psoriatic arthritis patients treated with Cosentyx® saw no progression of joint damage as shown in Novartis new two-year observational data

EAST HANOVER, N.J., Nov. 7, 2015 /PRNewswire/ -- Novartis announced two-year data for Cosentyx^® (secukinumab) from an observational sub-analysis of a pivotal Phase III trial showing no progression of radiographic joint damage in approximately 84% of patients treated over a 104 Week time period with either Cosentyx 75 mg (n=155) or 150 mg (n=167). Additionally, patients maintained treatment response in joint and skin disease measures.¹ These results from the extension phase of the FUTURE 1 study, where patients received either 75 mg or 150 mg of Cosentyx, will be presented at the 2015 Annual Meeting of the American College of Rheumatology (ACR) in San Francisco.

These extension data add to the body of evidence for Cosentyx, the first IL-17A antagonist to demonstrate efficacy in controlled Phase III PsA studies.

"Psoriatic arthritis can have a profound impact on a patient's quality of life," said Philip Mease, MD, clinical professor at the University of Washington School of Medicine in Seattle, director of the Rheumatology Clinical Research Division of Swedish Medical Center, and an investigator in the Cosentyx clinical trial program. "Because not all patients with PsA respond to currently available therapies, it's important that we continue to explore new treatment options."

Results from the FUTURE 1 study represent the longest Cosentyx Phase III study in PsA to date. Similar responses were seen across two years in joint and skin disease as seen at the study's primary endpoint at Week 24, which showed a significant improvement compared to placebo as measured by the ACR response criteria. After two years of treatment, the majority of patients on both the 75 mg and 150 mg doses maintained the standard treatment goal of a 20% improvement in PsA symptoms as measured by ACR response criteria (ACR 20) in observed patient data at Week 104.¹

The most common adverse events (AEs) for either Cosentyx dose were nasopharyngitis (the common cold, 19.6%), upper respiratory tract infection (19.1%) and back pain (8.9%). Serious adverse event (SAE) rates were 17.3% and 11.0% for Cosentyx 150 mg and 75 mg, respectively.¹

About the FUTURE 1 study
FUTURE 1 is the first multi-center, randomized, placebo-controlled Phase III study to evaluate the efficacy and safety of Cosentyx in PsA. The study enrolled 606 patients with active PsA, including patients who had been previously treated with DMARDs (disease-modifying anti-rheumatic drugs) and patients who had an inadequate response or did not tolerate anti-TNFs, and assessed Cosentyx with intravenous loading (10 mg/kg) and subcutaneous (75 mg and 150 mg) maintenance dosing. In the study, patients received an intravenous loading dose every two weeks for the first four weeks of treatment followed by monthly subcutaneous doses of 75 mg or 150 mg compared to placebo.² At Week 16, patients in the placebo arm of the study were re-randomized to receive Cosentyx 150 mg or 75 mg from either Week 16 or Week 24, based on clinical response.^1,2

The study met its primary endpoint, the American College of Rheumatology response criteria (ACR 20), at Week 24:²

• 50.5% and 50.0% for Cosentyx 75 mg and 150 mg treatment arms, versus 17.3% for placebo; p<0.001

Pre-specified secondary endpoints at Week 24 in FUTURE 1 were:²

• 75% and 90% improvement in Psoriasis Area-and-Severity Index score (PASI 75 and PASI 90) among subjects with ≥3% of body surface area affected by psoriasis at baseline
• Change from baseline in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP)
• Quality of life assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) version 2 physical component summary score
• Physical function assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI)
• ACR 50 response
• Radiographic progression assessed using the van der Heijde modified total Sharp score (mTSS)
• Presence of dactylitis (assessed by dactylitic digit count) and enthesitis (assessed by a four-point enthesitis index) amongst subjects with these characteristics at baseline
• Overall safety and tolerability of each Cosentyx regimen compared with placebo

In total, 233/295 and 243/296 patients randomized to Cosentyx 75 mg and 150 mg either at the beginning of the study, or randomized from placebo at Week 16 or Week 24, completed 104 weeks.¹ Observed analyses included in the extension phase at 104 weeks included only data available at a given time point.

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).⁴ Between 0.3% and 1% of the general population may be affected by PsA and up to 15% of people with psoriasis may have undiagnosed PsA.^7,8 Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis, and irreversible joint damage.⁶ PsA can lead to irreversible joint damage and disability caused by years of inflammation.^2,3,6 Up to 40% of people can suffer from joint destruction and permanent physical deformity.⁹ New medicines are needed as many patients do not respond to, or tolerate current therapies and approximately 45% of PsA patients are dissatisfied with treatments.⁵

About Cosentyx and interleukin-17A (IL-17A)
Cosentyx is not indicated for PsA.

Cosentyx is a human monoclonal antibody (mAb) that selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor.¹⁰ Cosentyx is the first IL-17A antagonist to report positive results in PsA Phase III trials.^2,3 Research suggests that IL-17A may play an important role in driving the body's immune response in certain inflammatory arthritic diseases, including PsA.¹¹

In January 2015, Cosentyx became the first and only IL-17A antagonist approved by the FDA as a treatment for moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy).

INDICATION

COSENTYX^® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Infections
COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in subjects treated with COSENTYX compared to placebo-treated subjects. In placebo-controlled clinical trials, higher rates of common infections such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%), and mucocutaneous infections with candida (1.2% versus 0.3%) were observed with COSENTYX compared with placebo. The incidence of some types of infections appeared to be dose-dependent in clinical studies.

Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and COSENTYX should be discontinued until the infection resolves.

Pre-treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Do not administer COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving COSENTYX should be monitored closely for signs and symptoms of active TB during and after treatment.

Exacerbations of Crohn's Disease
Exercise caution when prescribing COSENTYX to patients with active Crohn's disease, as exacerbations of Crohn's disease, in some cases serious, were observed in patients treated with COSENTYX during clinical trials. Patients who are treated with COSENTYX and have active Crohn's disease should be monitored closely.

Hypersensitivity Reactions
Anaphylaxis and cases of urticaria occurred in patients treated with COSENTYX in the clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.

The removable cap of the COSENTYX Sensoready^® pen and the COSENTYX prefilled syringe contains natural rubber latex which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

Vaccinations
Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with COSENTYX should not receive live vaccines.

Non-live vaccinations received during a course of COSENTYX may not elicit an immune response sufficient to prevent disease.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.

Please see accompanying full Prescribing Information, including Medication Guide.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "will," "can," "explore," "may," "suggests," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Cosentyx, or regarding potential future revenues from Cosentyx, or regarding the long-term impact of a patient's use of Cosentyx. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 Cosentyx will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Cosentyx will be commercially successful in the future. Neither can there be any guarantee regarding the long-term impact of a patient's use of Cosentyx. In particular, management's expectations regarding Cosentyx could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety issues; unexpected manufacturing or quality 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
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative medicines aimed at improving patients' lives. We offer a broad range of medicines for cancer, cardiovascular disease, endocrine disease, inflammatory disease, infectious disease, neurological disease, organ transplantation, psychiatric disease, respiratory disease and skin conditions. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, 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, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

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