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
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...