Business Wire

New Three-Year Data for Janssen’s TREMFYA®▼ (Guselkumab) Demonstrates Well Maintained Rates of Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis

Jaa

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new long-term data from the open-label period of the VOYAGE 1 clinical study. The data demonstrate well maintained rates of skin clearance with TREMFYA®▼ (guselkumab) treatment at Week 52 (1 year) and Week 156 (3 years) among adult patients with moderate to severe plaque psoriasis.1 The findings, presented at the 37th Fall Clinical Dermatology Conference in Las Vegas, USA, showed nearly 83 percent of patients receiving guselkumab in the Phase 3 VOYAGE 1 study maintained at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90), or near complete skin clearance, and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at Week 156.1

“These findings are impressive as they demonstrate consistency in high rates of skin clearance with guselkumab treatment at Weeks 48, 100 and 156, with every eight-week maintenance therapy,” said Andrew Blauvelt, MD, MBA, President, Oregon Medical Research Center, and VOYAGE 1 study steering committee member.* “In the management of moderate to severe plaque psoriasis, including symptom relief as well as skin clearance, it is essential that we continue to evaluate the impact of treatments with long-term data like those presented today. The VOYAGE 1 findings help further our understanding of the long-term impact of targeting IL-23 with guselkumab in the treatment of plaque psoriasis.”

Results from the open-label extension of the VOYAGE 1 Phase 3 clinical study showed that at Week 156, in the combined group of patients initially randomised to guselkumab, or to placebo with crossover to guselkumab at Week 16, 82.1 percent achieved an IGA score of 0/1 (cleared or minimal disease), 96.4 percent achieved a PASI 75 score, and 82.8 percent achieved a PASI 90 score (near complete skin clearance).1

At Week 156, 53.1 percent of patients achieved an IGA score of 0 and 50.8 percent of patients achieved a PASI 100 response. These measures represent skin completely cleared of psoriasis plaques (except for residual discoloration) and are consistent with the PASI 100 and IGA 0 results demonstrated at Week 100.1

Responses based on the Psoriasis Symptoms and Signs Diary (PSSD) were also consistent at Week 100 and Week 156. This tool evaluates patient-reported symptoms (i.e., itch, pain, stinging, burning and skin tightness) and signs (i.e., skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding).2 The percentage of patients receiving a PSSD symptom score of 0 was 40.2 percent at Week 100 and 40.4 at Week 156.1

“We are very pleased and excited by these results. The data adds to the growing body of safety and efficacy evidence with the use of guselkumab over a three-year period,” said Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC. “As a part of our commitment to developing innovative therapies for chronic, immune-mediated diseases like psoriasis, we have been focusing on generating long-term data so that patients and physicians can be more informed when making treatment decisions.”

The findings follow the first two positive Health Technology Appraisals in Europe for guselkumab since marketing authorisation was granted in November 2017; the United Kingdom’s National Institute for Health and Care Excellence (NICE), and Germany’s drug reimbursement body, The Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA).3,4

During clinical development, guselkumab was generally well tolerated by patients with psoriasis.5,6,7 The very common and common adverse events associated with guselkumab are as follows: upper respiratory infection (very common, ≥1/10) and arthralgia, diarrhoea, gastroenteritis, headache, herpes simplex infections, injection site erythema, tinea infections and urticaria (common, ≥1/100 to <1/10). Injection site pain has been reported as an uncommon adverse event (≥1/1,000 to <1/100).8 In this study, the types of adverse events reported remained consistent through 156 weeks of treatment.1,5,6

#ENDS#

*Dr. Blauvelt is a paid consultant for Janssen. He was not compensated for any media work.

About psoriasis

What it is

The most common form of psoriasis is plaque psoriasis, usually resulting in areas of thick, red or inflamed skin covered with silvery scales which are known as plaques.9 The inconsistent nature of psoriasis means that even when plaques appear to subside, patients can have ongoing concerns over their return.

Impact

Psoriasis can cause great physical and psychological burden. Mental health issues are common among people with psoriasis, and the impact it can have on quality of life is comparable to diabetes and cancer.10 Psoriasis is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder (COPD) and osteoporosis.11 In addition, many individuals are faced with social exclusion, discrimination and stigma because of their disease.12

About TREMFYA ® (guselkumab) 8

On 10 November 2017, TREMFYA® (guselkumab) was granted market authorisation in the European Union for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy).8

Guselkumab is the first psoriasis treatment licensed in the European Union to selectively target IL-23, a key driver of the immune inflammatory response in psoriasis.5,6,7,13 It is a subcutaneous, self-injectable treatment for psoriasis (following training). Treatment requires two starter doses, one initially and the other four weeks later, followed by a maintenance dose once every eight weeks (q8w) thereafter.5,6,14

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to guselkumab, which is currently approved in the US, Canada and the European Union.

VOYAGE 1 study

  • VOYAGE 1 is a Phase 3, multicentre, randomised, double-blind, placebo- and active comparator-controlled study, including 837 patients. It included a placebo-controlled period (Weeks 0–16), after which patients taking placebo crossed over to receive guselkumab through Week 48, and an active comparator-controlled period comparing guselkumab with adalimumab (Week 0-48).5,6,14 Patients randomised to guselkumab at Week 0 and those who crossed over from placebo to guselkumab at Week 16 continued to receive guselkumab q8w at Week 48.5,14 Beginning at Week 52, all patients began receiving open-label guselkumab. This study will continue for a total of 5 years. Results presented to date include findings through Week 156 of the study. Through Week 48, non-responder imputation rules were used for missing data, while after Week 48 no missing data were imputed after the application of treatment failure rules.

Prescribing and safety information

For complete European Union (EU) prescribing and safety information, please visit: https://www.medicines.org.uk/emc/medicine/34321

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Ltd on 01494 567447.

Clinical development programme

Phase 3 studies are being undertaken to evaluate the efficacy and safety of guselkumab for patients with psoriatic arthritis and Crohn’s disease.15,16 A Phase 3 comparator study (the ECLIPSE study) is underway to evaluate the efficacy of guselkumab versus Cosentyx® (secukinumab), an IL-17A inhibitor, in patients with moderate to severe plaque psoriasis.14

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/EMEA. Follow us on Twitter: @JanssenEMEA.

Janssen-Cilag International NV, the marketing authorisation holder for TREMFYA® in the European Union, Janssen-Cilag Ltd, and Janssen Research & Development, LLC, are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development and potential availability in the European Union of guselkumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen-Cilag Ltd, Janssen Research & Development, LLC, or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services, changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

# # #

References

1. Griffiths et al. Maintenance of response with guselkumab for up to 3 years’ treatment in the Phase 3 VOYAGE 1 trial of patients with plaque psoriasis. Falls Clinical Dermatology Conference 2018 18–12 Oct, 2018;Las Vegas, USA.

2. Armstrong, A et al. Validation of psychometric properties and development of response criteria for the Psoriasis Symptoms and Signs Diary (PSSD): Results from a Phase III clinical trial. J Dermatol Treat 2017;11:1–31.

3. National Institute of Health and Care Excellence (NICE). Guselkumab for treating moderate to severe plaque psoriasis [TA521]. Available at: www.nice.org.uk/guidance/TA521. Last accessed October 2018.

4. Gemeinsamer Bundesausschuss. Reasons for the decision of the Common Federal Committee on an amendment to the Medicinal Products Directive (AM-RL): Annex XII -Decisions on the benefit assessment of Medicines containing new active substances according to § 35a SGB V - Guselkumab. Available at: https://www.g-ba.de/downloads/40-268-4987/2018-05-17_AM-RL-XII_Guselkumab_D-330_TrG.pdf. Last accessed October 2018.

5. Blauvelt A, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 2017;76(3):405–17.

6. Reich K, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the Phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol 2017;76(3):418–31.

7. Langley R, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol 2018;178(1):114–23.

8. European Medicines Agency. Tremfya 100mg solution for injection. 2017. Available at: https://www.medicines.org.uk/emc/medicine/34321. Accessed October 2018.

9. British Skin Foundation. Psoriasis. Available at: www.britishskinfoundation.org.uk/SkinInformation/AtoZofSkindisease/Psoriasis.aspx. Accessed October 2018.

10. Bajorek Z, et al. The impact of long term conditions on employment and the wider UK economy. The Work Foundation. 2016. Available at: http://www.theworkfoundation.com/wp-content/uploads/2016/11/397_The-impact-of-long-term-conditions-on-the-economy.pdf. Accessed October 2018.

11. Nijsten T, et al. Complexity of the association between psoriasis and comorbidities. Journal of Investigative Dermatology 2009;129(7):1601–03.

12. World Health Organization (2016) Global Report on Psoriasis. Available at: apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf. Last accessed October 2018.

13. Bachelez, H. Interleukin 23 inhibitors for psoriasis: not just another number. The Lancet 2017;390(10091):208–10.

14. ClinicalTrials.gov. A study to evaluate the comparative efficacy of CNTO 1959 (guselkumab) and secukinumab for the treatment of moderate to severe plaque-type psoriasis (ECLIPSE). Identifier NCT03090100. Available at: https://clinicaltrials.gov/ct2/show/NCT03090100. Accessed October 2018.

15. ClinicalTrials.gov. A study evaluating the efficacy and safety of guselkumab administered subcutaneously in participants with active psoriatic arthritis. Identifier NCT03158285. Available at: https://clinicaltrials.gov/ct2/show/NCT03158285. Accessed October 2018.

16. ClinicalTrials.gov. A study of the efficacy and safety of guselkumab in participants with moderately to severely active crohn's disease (GALAXI). Identifier NCT03466411. Available at: https://clinicaltrials.gov/ct2/show/NCT03466411. Accessed October 2018.

PHEM/IMM/0918/0023

Contact information

Janssen
Media Enquiries:
Emily Bone
Mobile: +44 7876 394 360
Email: ebone1@ITS.JNJ.com
or
Investor Relations:
Christopher DelOrefice
Phone: +1 732-524-2955
or
Lesley Fishman
Phone: +1 732-524-3922

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Global Launch of S BLOCK, Kicked Off in Singapore on June 22nd24.6.2019 15:29:00 EESTTiedote

The globally renowned 2019 WBF Singapore Technology Conference was held in Marina Bay Sands Hotel on June 22nd, 2019. S BLOCK, the conference co-host, unveiled itself and announce its mission to “Unleash your digital assets” for the first time. The conference brought together numerous industry elites and blockchain enthusiasts from all around the world, including more than 500 industry veterans from over 30 countries, such as Switzerland, Germany, France, Russia, Japan, Korea, Brazil, Australia, Argentina and Canada. Insiders shared profound global industry insights. This conference draws great attention from across the global blockchain industry. S BLOCK Kicked Off in Singapore In the morning of June 22nd, Ivan - President of S BLOCK Global Foundation, was invited to deliver a keynote speech, “Next Generation Digital Currency Wallet”. At this conference, S BLOCK was officially launched in more than 30 countries around the world, and opened up the way to a global future without borders

SpeeDx announce a collaborative agreement with GSK to supply tests and technology24.6.2019 15:00:00 EESTTiedote

SpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, has signed a collaborative agreement with GSK, to provide a combination of existing tests and custom test development to support certain GSK antibiotic clinical trials and new product development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190624005302/en/ “SpeeDx has a demonstrated commitment to improve patient care, and our tests currently used in clinical practice are supporting Resistance Guided Therapy, positively impacting cure rates and helping to minimise the spread of antimicrobial resistant infections.” Colin Denver, SpeeDx CEO. (Photo: Business Wire) “We welcome this extension of the utility and application of our tests and technology,” said Colin Denver, SpeeDx CEO. “SpeeDx has a demonstrated commitment to improve patient care, and our tests currently used in clinical practice are supporting Resistance Guided Therapy, positively impac

Nexon Computer Museum to Hold the Fourth VR Content Contest24.6.2019 13:13:00 EESTTiedote

Nexon Computer Museum (NCM) of NXC is holding the fourth virtual reality content contest, ‘2019 NCM OPEN CALL X REALITY’. NXC is a holding company of Nexon (TOKYO: 3659). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190624005284/en/ Nexon Computer Museum (NCM) of NXC is holding the fourth virtual reality content contest 2019 NCM OPEN CALL X REALITY with total prize money of KRW 13 million. Application received from July 1st to August 31st, winners announced on October 25th. (Graphic: Business Wire) NCM OPEN CALL is an exhibit to discover and support virtual reality content creators. This year’s keyword ‘X REALITY’ encompasses all kinds of virtualization including VR, AR, MR, and more. It also implies eXtended Reality, which broadens the perspectives of reality, and Cross Reality, which overlaps the real and virtual world. The unpredictable X signifies NCM OPEN CALL’s pursuit towards embracing various kinds of innovative an

REPLY: New Tool “China Beats” Provides Deep Insights Into the Chinese Market24.6.2019 12:15:00 EESTTiedote

TD Reply, the company specializing in marketing and innovation consulting within the Reply Group, developed China Beats, a business intelligence solution that enables companies to gain an in-depth understanding of the Chinese market and its players. This is ensured by AI-supported social listening with connection to all major Chinese e-commerce, social media and search platforms such as Alibaba, Baidu, WeChat and Weibo. The prosperity of the Chinese population is growing at a rapid pace. According to analysts estimates, around 550 million Chinese will belong to the middle class by 2022. As a result, the Chinese market is also becoming increasingly important for international companies. Entering the market, however, is challenging, especially in terms of reliable identification of target groups, analysis of their consumer behavior and preferences. Digital data can provide a remedy, because the majority of Chinese consumers are netizens who shop on digital platforms, exchange their opini

MYbank Works With Financial Institution Partners to Serve Over 15 Million SMEs24.6.2019 08:42:00 EESTTiedote

MYbank, a leading online private commercial bank in China with a focus on SME financing, today announced that the bank’s Star Plan has enabled MYbank, with its financial institution partners, to serve over 15 million small and micro enterprises (SMEs). SMEs are key drivers of economic growth and this partnership is now serving more SMEs than any other in the world. The announcement comes on the day that MYbank celebrates its 4th Anniversary. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190623005055/en/ MYbank’s 310 lending model enables inclusive finance for SMEs in China (Photo: Business Wire) MYbank’s Star Plan was announced on June 21, 2018 with the aim of using technology to enable 1,000 financial institution partners to provide more cost-effective financing services to 30 million SMEs in China within a three-year period. A little over a year later and the Star Plan is showing significant progress. As of June 2019, lev

CORRECTING and REPLACING Cooper & Turner Announces Exclusivity for Potential Combination with Beck Industries21.6.2019 22:51:00 EESTTiedote

Please replace the release dated June 19, 2019, with the following corrected version due to changes to the headline and first sentence of release. The corrected release reads: COOPER & TURNER ANNOUNCES EXCLUSIVITY FOR POTENTIAL COMBINATION WITH BECK INDUSTRIES Andaray (Holdings) Limited and its direct and indirect subsidiaries (“Cooper & Turner”) have entered into an exclusivity agreement with Beck Industries (“Beck”) for potential combination of the two groups. The contemplated combined entity aims to be the first truly global manufacturer of safety critical fasteners, together supporting a broader range of industries – including renewable energy, tunneling, construction, rail, heavy equipment, downstream oil & gas, power generation and nuclear, among others. Headquartered in Sheffield, England, Cooper & Turner serves a global customer base with manufacturing and distribution operations across the European Union, China and North America. This worldwide network enables Cooper & Turner

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme