- Structural joint damage in psoriatic arthritis (PsA) patients taking Cosentyx® (secukinumab) was inhibited at 24 weeks versus placebo in all arms of the study[1]
- PsA can lead to reduced mobility and irreversible joint damage[2]
- FUTURE 5 is the largest randomized controlled trial of a biologic conducted to date in PsA, with nearly 1,000 patients studied[1]
BASEL, 10-Nov-2017 — /EuropaWire/ — 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[1]. 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 a painful, progressively debilitating inflammatory disease. Up to 40% of PsA patients can suffer from joint damage and permanent physical deformity[3].
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[4].
“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 27.4% (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],[5]. 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 receive 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[6].
About the FUTURE 5 study (NCT02404350)[1]
In the study, participants (n=996) with active PsA were randomized to receive Cosentyx at 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 ACR 20 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 PsA
Closely associated with psoriasis, PsA is part of a spectrum of long-term diseases impacting joints, known as spondyloarthritis (SpA)[7]. Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful swelling of the tendons, and irreversible joint damage[2]. Up to 40% of people can suffer from joint destruction and permanent physical deformity[3].
PsA is closely associated with psoriasis. Up to 30% of psoriasis patients will develop PsA at some point during their lifetime[2] and as many as 1 in 4 people with psoriasis may have undiagnosed PsA[8].
About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx, launched in 2015, is the first and only fully human IL-17A inhibitor approved to treat PsA, AS, and psoriasis[9]. Cosentyx is a targeted treatment that specifically inhibits the IL-17A cytokine, which plays a significant role in the pathogenesis of PsA, AS and plaque psoriasis[9],[10],[11].
Cosentyx is the first IL-17A inhibitor approved in more than 70 countries for the treatment of active AS and PsA, which includes the European Union countries and the US. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan[12].
Cosentyx is also 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[9]. 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)[13].
To date, more than 100,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications[14]. In addition, 2017 marks 10 years since the first patient, first visit in a clinical trial with Cosentyx[14].
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
Novartis 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.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis(link is external)
For Novartis multimedia content, please visit www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com
References
[1] P. Mease, 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 2017 ACR/ARHP Annual Meeting. November 7, 2017.
[2] Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014; 74:423-441.
[3] Anwar AH, Diamond H. Psoriatic arthritis: practice essentials, background, pathophysiology and etiology. Medscape reference website. Available at: http://emedicine.medscape.com/article/2196539-overview#a6(link is external). Last accessed October 2017.
[4] D van der Heijde. Psoriatic arthritis imaging: a review of scoring methods. BMJ. 2005; 64(Suppl II):ii61-ii64. doi: 10.1136.
[5] National Psoriasis Foundation. Media Kit. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed May 2017(link is external).
[6] Novartis Data on File. FUTURE 5 First Interpretable Results: Week 24 Interim Analysis. August 2017.
[7] Armstrong A et al. Treatment Trends, and Treatment Dissatisfaction Among Patients With Psoriasis and Psoriatic Arthritis in the United States: Findings From the National Psoriasis Foundation Surveys, 2003-2011. JAMA Dermatol. 2013; 149(10):1180-1185.
[8] National Psoriasis Foundation. Could You Have Psoriatic Arthritis? Know the Signs. Available at
https://www.psoriasis.org/psoriatic-arthritis/know-the-signs(link is external). Last accessed October 2017.
[9] 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(link is external). Last accessed October 2017.
[10] Nestle FO et al. Mechanisms of disease psoriasis. New England Journal of Medicine. 2009;361:496-509
[11] Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. British Journal of Dermatology. 2012;167:717-24.
[12] Pharmaceuticals and Medical Devices Agency. Review Report. www.pmda.go.jp(link is external). http://www.pmda.go.jp/files/000216877.pdf(link is external). Last accessed October 2017.
[13] Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp, 2016.
[14] Novartis Data on file. Number of Patients Prescribed Cosentyx. May 2017.
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com
Eric Althoff Novartis Global Media Relations +41 61 324 7999 (direct) +41 79 593 4202 (mobile) eric.althoff@novartis.com |
Friedrich von Heyl Novartis Global Pharma Communications +41 61 324 8984 (direct) +41 79 749 0286 (mobile) friedrich.vonheyl@novartis.com |
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central | North America | ||
Samir Shah | +41 61 324 7944 | Richard Pulik | +1 212 830 2448 |
Pierre-Michel Bringer | +41 61 324 1065 | Cory Twining | +1 212 830 2417 |
Thomas Hungerbuehler | +41 61 324 8425 | ||
Isabella Zinck | +41 61 324 7188 |
SOURCE: Novartis AG
- Digi Communications N.V. announced that its Spanish subsidiary, Digi Spain Telecom S.L.U., has completed the first stage of selling a Fibre-to-the-Home (FTTH) network in 12 Spanish provinces
- Natural Cotton Color lancia la collezione "Calunga" a Milano
- Astor Asset Management 3 Ltd: Salinas Pliego Incumple Préstamo de $110 Millones USD y Viola Regulaciones Mexicanas
- Astor Asset Management 3 Ltd: Salinas Pliego Verstößt gegen Darlehensvertrag über 110 Mio. USD und Mexikanische Wertpapiergesetze
- ChargeEuropa zamyka rundę finansowania, której przewodził fundusz Shift4Good tym samym dokonując historycznej francuskiej inwestycji w polski sektor elektromobilności
- Strengthening EU Protections: Robert Szustkowski calls for safeguarding EU citizens’ rights to dignity
- Digi Communications NV announces the release of H1 2024 Financial Results
- Digi Communications N.V. announces that conditional stock options were granted to a director of the Company’s Romanian Subsidiary
- Digi Communications N.V. announces Investors Call for the presentation of the H1 2024 Financial Results
- Digi Communications N.V. announces the conclusion of a share purchase agreement by its subsidiary in Portugal
- Digi Communications N.V. Announces Rating Assigned by Fitch Ratings to Digi Communications N.V.
- Digi Communications N.V. announces significant agreements concluded by the Company’s subsidiaries in Spain
- SGW Global Appoints Telcomdis as the Official European Distributor for Motorola Nursery and Motorola Sound Products
- Digi Communications N.V. announces the availability of the instruction regarding the payment of share dividend for the 2023 financial year
- Digi Communications N.V. announces the exercise of conditional share options by the executive directors of the Company, for the year 2023, as approved by the Company’s Ordinary General Shareholders’ Meetings from 18th May 2021 and 28th December 2022
- Digi Communications N.V. announces the granting of conditional stock options to Executive Directors of the Company based on the general shareholders’ meeting approval from 25 June 2024
- Digi Communications N.V. announces the OGMS resolutions and the availability of the approved 2023 Annual Report
- Czech Composer Tatiana Mikova Presents Her String Quartet ‘In Modo Lidico’ at Carnegie Hall
- SWIFTT: A Copernicus-based forest management tool to map, mitigate, and prevent the main threats to EU forests
- WickedBet Unveils Exciting Euro 2024 Promotion with Boosted Odds
- Museum of Unrest: a new space for activism, art and design
- Digi Communications N.V. announces the conclusion of a Senior Facility Agreement by companies within Digi Group
- Digi Communications N.V. announces the agreements concluded by Digi Romania (formerly named RCS & RDS S.A.), the Romanian subsidiary of the Company
- Green Light for Henri Hotel, Restaurants and Shops in the “Alter Fischereihafen” (Old Fishing Port) in Cuxhaven, opening Summer 2026
- Digi Communications N.V. reports consolidated revenues and other income of EUR 447 million, adjusted EBITDA (excluding IFRS 16) of EUR 140 million for Q1 2024
- Digi Communications announces the conclusion of Facilities Agreements by companies from Digi Group
- Digi Communications N.V. Announces the convocation of the Company’s general shareholders meeting for 25 June 2024 for the approval of, among others, the 2023 Annual Report
- Digi Communications NV announces Investors Call for the presentation of the Q1 2024 Financial Results
- Digi Communications intends to propose to shareholders the distribution of dividends for the fiscal year 2023 at the upcoming General Meeting of Shareholders, which shall take place in June 2024
- Digi Communications N.V. announces the availability of the Romanian version of the 2023 Annual Report
- Digi Communications N.V. announces the availability of the 2023 Annual Report
- International Airlines Group adopts Airline Economics by Skailark ↗️
- BevZero Spain Enhances Sustainability Efforts with Installation of Solar Panels at Production Facility
- Digi Communications N.V. announces share transaction made by an Executive Director of the Company with class B shares
- BevZero South Africa Achieves FSSC 22000 Food Safety Certification
- Digi Communications N.V.: Digi Spain Enters Agreement to Sell FTTH Network to International Investors for Up to EUR 750 Million
- Patients as Partners® Europe Announces the Launch of 8th Annual Meeting with 2024 Keynotes and Topics
- driveMybox continues its international expansion: Hungary as a new strategic location
- Monesave introduces Socialised budgeting: Meet the app quietly revolutionising how users budget
- Digi Communications NV announces the release of the 2023 Preliminary Financial Results
- Digi Communications NV announces Investors Call for the presentation of the 2023 Preliminary Financial Results
- Lensa, един от най-ценените търговци на оптика в Румъния, пристига в България. Първият шоурум е открит в София
- Criando o futuro: desenvolvimento da AENO no mercado de consumo em Portugal
- Digi Communications N.V. Announces the release of the Financial Calendar for 2024
- Customer Data Platform Industry Attracts New Participants: CDP Institute Report
- eCarsTrade annonce Dirk Van Roost au poste de Directeur Administratif et Financier: une décision stratégique pour la croissance à venir
- BevZero Announces Strategic Partnership with TOMSA Desil to Distribute equipment for sustainability in the wine industry, as well as the development of Next-Gen Dealcoholization technology
- Digi Communications N.V. announces share transaction made by a Non-Executive Director of the Company with class B shares
- Digi Spain Telecom, the subsidiary of Digi Communications NV in Spain, has concluded a spectrum transfer agreement for the purchase of spectrum licenses
- Эксперт по торговле акциями Сергей Левин запускает онлайн-мастер-класс по торговле сырьевыми товарами и хеджированию
- Digi Communications N.V. announces the conclusion by Company’s Portuguese subsidiary of a framework agreement for spectrum usage rights
- North Texas Couple Completes Dream Purchase of Ouray’s Iconic Beaumont Hotel
- Предприниматель и филантроп Михаил Пелег подчеркнул важность саммита ООН по Целям устойчивого развития 2023 года в Нью-Йорке
- Digi Communications NV announces the release of the Q3 2023 Financial Results
- IQ Biozoom Innovates Non-Invasive Self-Testing, Empowering People to Self-Monitor with Laboratory Precision at Home
- BevZero Introduces Energy Saving Tank Insulation System to Europe under name “BevClad”
- Motorvision Group reduces localization costs using AI dubbing thanks to partnering with Dubformer
- Digi Communications NV Announces Investors Call for the Q3 2023 Financial Results
- Jifiti Granted Electronic Money Institution (EMI) License in Europe
- Предприниматель Михаил Пелег выступил в защиту образования и грамотности на мероприятии ЮНЕСКО, посвящённом Международному дню грамотности
- VRG Components Welcomes New Austrian Independent Agent
- Digi Communications N.V. announces that Digi Spain Telecom S.L.U., its subsidiary in Spain, and abrdn plc have completed the first investment within the transaction having as subject matter the financing of the roll out of a Fibre-to-the-Home (“FTTH”) network in Andalusia, Spain
- Продюсер Михаил Пелег, как сообщается, работает над новым сериалом с участием крупной голливудской актрисы
- Double digit growth in global hospitality industry for Q4 2023
- ITC Deploys Traffic Management Solution in Peachtree Corners, Launches into United States Market
- Cyviz onthult nieuwe TEMPEST dynamische controlekamer in Benelux, Nederland
- EU-Funded CommuniCity Launches its Second Open Call
- Astrologia pode dar pistas sobre a separação de Sophie Turner e Joe Jonas
- La astrología puede señalar las razones de la separación de Sophie Turner y Joe Jonas
- Empowering Europe against infectious diseases: innovative framework to tackle climate-driven health risks
- Montachem International Enters Compostable Materials Market with Seaweed Resins Company Loliware
- Digi Communications N.V. announces that its Belgian affiliated companies are moving ahead with their operations
- Digi Communications N.V. announces the exercise of conditional share options by an executive director of the Company, for the year 2022, as approved by the Company’s Ordinary General Shareholders’ Meeting from 18 May 2021
- Digi Communications N.V. announces the availability of the instruction regarding the payment of share dividend for the 2022 financial year
- Digi Communications N.V. announces the availability of the 2022 Annual Report
- Digi Communications N.V. announces the general shareholders’ meeting resolutions from 18 August 2023 approving amongst others, the 2022 Annual Accounts
- Русские эмигранты усиливают призывы «Я хочу, чтобы вы жили» через искусство
- BevZero Introduces State-of-the-Art Mobile Flash Pasteurization Unit to Enhance Non-Alcoholic Beverage Stability at South Africa Facility
- Russian Emigrés Amplify Pleas of “I Want You to Live” through Art
- Digi Communications NV announces the release of H1 2023 Financial Results
- Digi Communications NV Announces Investors Call for the H1 2023 Financial Results
- Digi Communications N.V. announces the convocation of the Company’s general shareholders meeting for 18 August 2023 for the approval of, among others, the 2022 Annual Report
- “Art Is Our Weapon”: Artists in Exile Deploy Their Talents in Support of Peace, Justice for Ukraine
- Digi Communications N.V. announces the availability of the 2022 Annual Financial Report
- “AmsEindShuttle” nuevo servicio de transporte que conecta el aeropuerto de Eindhoven y Ámsterdam
- Un nuovo servizio navetta “AmsEindShuttle” collega l’aeroporto di Eindhoven ad Amsterdam
- Digi Communications N.V. announces the conclusion of an amendment agreement to the Facility Agreement dated 26 July 2021, by the Company’s Spanish subsidiary
- Digi Communications N.V. announces an amendment of the Company’s 2023 financial calendar
- iGulu F1: Brewing Evolution Unleashed
- Почему интерактивная «Карта мира» собрала ключевые антивоенные сообщества россиян по всему миру и становится для них важнейшим инструментом
- Hajj Minister meets EU ambassadors to Saudi Arabia
- Online Organizing Platform “Map of Peace” Emerges as Key Tool for Diaspora Activists
- Digi Communications N.V. announces that conditional stock options were granted to executive directors of the Company based on the general shareholders’ meeting approval from 18 May 2021
- Digi Communications N.V. announces the release of the Q1 2023 financial results
- AMBROSIA – A MULTIPLEXED PLASMO-PHOTONIC BIOSENSING PLATFORM FOR RAPID AND INTELLIGENT SEPSIS DIAGNOSIS AT THE POINT-OF-CARE
- Digi Communications NV announces Investors Call for the Q1 2023 Financial Results presentation
- Digi Communications N.V. announces the amendment of the Company’s 2023 financial calendar
- Digi Communications N.V. announces the conclusion of two Facilities Agreements by the Company’s Romanian subsidiary
- Digi Communications N.V. announces the conclusion of a Senior Facility Agreement by the Company’s Romanian subsidiary
- Patients as Partners Europe Returns to London and Announces Agenda Highlights
- GRETE PROJECT RESULTS PRESENTED TO TEXTILE INDUSTRY STAKEHOLDERS AT INTERNATIONAL CELLULOSE FIBRES CONFERENCE
- Digi Communications N.V. announces Digi Spain Telecom S.L.U., its subsidiary in Spain, entered into an investment agreement with abrdn to finance the roll out of a Fibre-to-the-Home (FTTH) network in Andalusia, Spain
- XSpline SPA / University of Linz (Austria): the first patient has been enrolled in the international multicenter clinical study for the Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment (CRT-DRIVE)
- Franklin Junction Expands Host Kitchen® Network To Europe with Digital Food Hall Pioneer Casper
- Unihertz a dévoilé un nouveau smartphone distinctif, Luna, au MWC 2023 de Barcelone
- Unihertz Brachte ein Neues, Markantes Smartphone, Luna, auf dem MWC 2023 in Barcelona
- Editor's pick archive....