Click here to close now.




















Welcome!

News Feed Item

Novartis reports new Phase III data showing secukinumab (AIN457) improved moderate-to-severe plaque psoriasis in patients

- FEATURE and JUNCTURE data show secukinumab delivered significant skin clearance at week 12(1,2)

EAST HANOVER, N.J., March 22, 2014 /PRNewswire/ -- Novartis today announced results from the Phase III FEATURE and JUNCTURE studies showing secukinumab (AIN457), a selective interleukin-17A (IL-17A) inhibitor, met both co-primary endpoints at Week 12 based on Psoriasis Area and Severity Index (PASI) 75 and Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response rates compared to placebo. Results from these studies also demonstrated skin clearance at Week 12 based on PASI 90 response rates compared to placebo, usability and acceptability of the secukinumab pre-filled syringe (PFS) and autoinjector pen (AI), and an approximately 50% mean decrease in PASI scores from baseline by Week 3 (300mg) and Week 4 (150mg).(1,2,3,4) These results, along with more than 20 posters were presented for the first time at the 72nd Annual Meeting of the American Academy of Dermatology (AAD) in Denver.

"The results from FEATURE and JUNCTURE offer insights into the potential of secukinumab as a treatment option for moderate-to-severe plaque psoriasis," said Andre Wyss, President, Novartis Pharmaceuticals Corporation, and President, Novartis Corporation. "We are committed to developing innovative therapies that address significant patient unmet needs. We look forward to providing additional information from ongoing secukinumab clinical trials to the dermatology community." 

FEATURE results showed the efficacy of secukinumab 300mg and 150mg based on a statistically significant higher proportion of patients who achieved a PASI 75 response at Week 12 compared with placebo patients: 75.9% (300mg) and 69.5% (150mg), versus 0% for placebo (p <.0001). On the co-primary endpoint, the efficacy of secukinumab 300mg and 150mg was shown based on a statistically significant higher proportion of patients who achieved an IGA mod 2011 0/1 response at Week 12 compared with placebo: 69.0% (300mg) and 52.5% (150mg), versus 0% for placebo (p <.0001).(1)

Results from JUNCTURE also showed the efficacy of secukinumab 300mg and 150mg based on a statistically significant higher proportion of patients who achieved a PASI 75 response at Week 12 compared with placebo: 86.7% (300mg) and 71.7% (150mg), versus 3.3% for placebo (p <.0001). On the co-primary endpoint, the efficacy of secukinumab 300mg and 150mg was shown based on a statistically significant higher proportion of patients who achieved an IGA mod 2011 0/1 response at Week 12 compared with placebo: 73.3% (300mg) and 53.3% (150mg), versus 0% placebo (p <.0001).(2)

Additionally, more secukinumab patients in both studies experienced an improvement in PASI of greater than or equal to 90% (PASI 90) from baseline as compared to placebo,(1,2) which is a higher standard of skin clearance compared to PASI 75. In FEATURE 60.3% (300mg) and 45.8% (150mg) of secukinumab patients achieved a PASI 90 response at Week 12 compared to 0% of placebo patients (p <.0001).(1) In JUNCTURE, 55% (300mg) and 40% (150mg) of secukinumab patients achieved a PASI 90 response at Week 12 compared to 0% of placebo patients (p <.0001).(2)

In FEATURE (n=177), the most common adverse events (AEs) in any treatment group including placebo were diarrhea, nasopharyngitis and headache. There were a total of four serious adverse events in the study – three (5.1%) in the 300mg secukinumab arm and one (1.7%) in the placebo arm. Two patients (one in secukinumab 300mg arm, one in placebo arm) discontinued due to AEs.(1) In JUNCTURE (n=182), the most common AEs in any treatment group including placebo were nasopharyngitis, headache, pruritus and hypertension.(2) There were a total of five serious adverse events in the study – one (1.7%) in the 300mg secukinumab arm, three (4.9%) in the 150mg secukinumab arm and one (1.6%) in the placebo arm. One patient in the placebo arm discontinued due to adverse event.(2) There were no deaths reported during either study.(1,2)  

Patient satisfaction and usability data related to self-injection also presented at AAD
A secondary endpoint of both FEATURE and JUNCTURE measured patient satisfaction and usability with self-injection of secukinumab via PFS and AI, respectively. Satisfaction was assessed in both studies using a self-administered Self-Injection Assessment Questionnaire (SIAQ) which measures overall subject experience with subcutaneous self-injection before the first self-injection and after dosing on the domains of feelings about injections, self-confidence, satisfaction with self-injection, injection-site reactions, ease of use, and self-image. Overall, patient-reported acceptability of both the PFS and AI were high at baseline across both studies and remained high during the study. These studies were presented in separate posters at AAD.(3,4)

"Treating psoriasis can be challenging as not all treatments are appropriate or effective in every patient," said Dr. Andrew Blauvelt, President of the Oregon Medical Research Center and an investigator in the secukinumab clinical trial program. "The clinical data we have seen with secukinumab suggest it may offer a new therapeutic approach for patients living with moderate-to-severe plaque psoriasis."

Studies presented at AAD are part of a clinical program reporting results in moderate-to-severe plaque psoriasis with more than 3,000 patients in over 35 countries.

About FEATURE
FEATURE (First study of sEcukinumAb in prefilled syringes in subjecTs with chronic plaqUe-type psoriasis REsponse) was a randomized double-blind, placebo-controlled, multicenter, Phase III study involving 177 subjects with moderate-to-severe plaque psoriasis. In this study, prefilled syringes (PFS) were introduced into the secukinumab clinical program.(1)  

The co-primary endpoints were assessed at Week 12 and compared secukinumab efficacy versus placebo according to PASI 75 and Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response. Secondary endpoints included PASI 90 response up to Week 12 and patient satisfaction with self-injection of secukinumab via PFS determined by a self-administered Self-Injection Assessment Questionnaire (SIAQ). The trial is ongoing.(1)  

About JUNCTURE
JUNCTURE (Judging the efficacy of secUkinumab in patients with psoriasis using autoiNjector: a Clinical Trial evalUating treatment REsults) was a double-blind, placebo-controlled, multicenter, Phase III study involving 182 subjects with moderate-to-severe plaque psoriasis. In this study, the autoinjector/pen (AI) was introduced into the secukinumab clinical program.(2)  

The co-primary endpoints were PASI 75 and Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response for secukinumab vs placebo at Week 12. Secondary endpoints included PASI 90 response up to Week 12 and patient satisfaction with self-injection of secukinumab via the AI device determined by a self-administered Self-Injection Assessment Questionnaire (SIAQ). The trial is ongoing.(2) 

About secukinumab (AIN457) and interleukin-17A (IL-17A)
Secukinumab (AIN457), an investigational agent, is a fully human monoclonal antibody (mAb) that selectively targets interleukin IL-17A.(5) Secukinumab has been shown to selectively bind to and neutralize IL-17A, inhibiting its pro-inflammatory effects.(6,7)

IL-17A is a key cytokine (messenger protein) involved in the development of plaque psoriasis, and is found in high concentrations in psoriasis skin plaques.(8) Research shows that IL-17A plays an important role in driving the body's immune response in disorders such as moderate-to-severe plaque psoriasis and may represent a new target for investigational therapies.(9,10)

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "to be," "offer," "potential," "committed," "innovative," "look forward," "ongoing," "can," "suggest," "may," "investigational," or by express or implied discussions regarding potential marketing approvals for AIN457 or regarding potential future revenues from AIN457. 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 AIN457 will be approved for sale in any market where it has been submitted, or that AIN457 will be submitted or approved for sale in any additional markets, or at any particular time.  Nor can there be any guarantee that AIN457 will achieve any particular levels of revenue in the future. In particular, management's expectations regarding these products could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including ongoing pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; unexpected manufacturing issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. 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, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 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 136,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

 

Novartis Media Relations




Julie Masow

Michelle Bauman

Novartis Media Relations

Novartis Pharmaceuticals Corporation

+1 212-830-2465 (direct)

+1 862-778-6519 (direct)

+1 862-579-8456 (mobile)

+1 973-714-8043 (mobile)

[email protected]

[email protected]



e-mail: [email protected]


For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis.
For questions about the site or required registration, please contact: [email protected].


(1) Blauvelt A, Prinz J, Gottlieb AB, et al. Secukinumab Efficacy and Safety: Results From the First Study of Secukinumab in Prefilled Syringes in Subjects with Chronic Plaque-Type Psoriasis Response at 12 Weeks (FEATURE). E-poster presentation at: 72nd AAD Annual Meeting; Denver, Co.; 21-25 March 2014.
(2) Paul C, Lacour JP, Cooper S. Secukinumab Efficacy and Safety: Results From the Judging the Efficacy of Secukinumab in Patients With Psoriasis Using Autoinjector: A Clinical Trial Evaluating Treatment Results (JUNCTURE). E-poster presentation at: 72nd AAD Annual Meeting; Denver, Co.; 21-25 March 2014.
(3) Kingo K, Sofen H, Mallya U, et al. Secukinumab Prefilled Syringes Demonstrate Patient Satisfaction: Analysis of the Self-Injection Assessment Questionnaire (SIAQ) in the FEATURE Study. E-poster presentation at: 72nd AAD Annual Meeting; Denver, Co.; 21-25 March 2014.
(4) Kreutzer K, You R, Mallya U, et al. Secukinumab Autoinjectors Demonstrate Patient Satisfaction: An Analysis of the Self-Injection Assessment Questionnaire (SIAQ) in the JUNCTURE Study. E-poster presentation at: 72nd AAD Annual Meeting; Denver, Co.; 21-25 March 2014.
(5) Patel D. Effect of IL-17A blockade with secukinumab in autoimmune diseases. Ann Rheum Dis. 2013; 72: ii116-ii123.
(6) Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study. Brit J Dermatol 2013; 168, pp412-421.
(7) Rich PA, Sigurgeirsson B, Thaci D, et al. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. Brit J Dermatol 2013;168: 402-411.
(8) Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin Brit J Dermatol. 2009; 160:319-24.
(9) Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009; 9(8):556-67.
(10) Krueger J, Fretzin S, Suarez-Farinas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012; 130(1):145-154.

SOURCE Novartis Pharmaceuticals Corporation

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
Malicious agents are moving faster than the speed of business. Even more worrisome, most companies are relying on legacy approaches to security that are no longer capable of meeting current threats. In the modern cloud, threat diversity is rapidly expanding, necessitating more sophisticated security protocols than those used in the past or in desktop environments. Yet companies are falling for cloud security myths that were truths at one time but have evolved out of existence.
Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology. Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve. Digital Transformation means: handling all the data types being found and created in the organizat...
Public Cloud IaaS started its life in the developer and startup communities and has grown rapidly to a $20B+ industry, but it still pales in comparison to how much is spent worldwide on IT: $3.6 trillion. In fact, there are 8.6 million data centers worldwide, the reality is many small and medium sized business have server closets and colocation footprints filled with servers and storage gear. While on-premise environment virtualization may have peaked at 75%, the Public Cloud has lagged in adop...
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
The time is ripe for high speed resilient software defined storage solutions with unlimited scalability. ISS has been working with the leading open source projects and developed a commercial high performance solution that is able to grow forever without performance limitations. In his session at Cloud Expo, Alex Gorbachev, President of Intelligent Systems Services Inc., shared foundation principles of Ceph architecture, as well as the design to deliver this storage to traditional SAN storage co...
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with ...
The Cloud industry has moved from being more than just being able to provide infrastructure and management services on the Cloud. Enter a new era of Cloud computing where monetization’s services through the Cloud are an essential piece of strategy to feed your organizations bottom-line, your revenue and Profitability. In their session at 16th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed how to easily o...
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
Rapid innovation, changing business landscapes, and new IT demands force businesses to make changes quickly. The DevOps approach is a way to increase business agility through collaboration, communication, and integration across different teams in the IT organization. In his session at DevOps Summit, Chris Van Tuin, Chief Technologist for the Western US at Red Hat, will discuss: The acceleration of application delivery for the business with DevOps
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, S...