JANSSEN
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new open-label extension data from the Phase 3 VOYAGE 1 study, which showed high rates of skin clearance with TREMFYA® ▼ (guselkumab) and no new safety signals in adult patients with moderate to severe plaque psoriasis through nearly five years of treatment.1,2 At week 252 in the combined* guselkumab group, 84 percent of patients achieved a Psoriasis Area Severity Index (PASI) 90 response (a 90 percent improvement in the PASI score compared to baseline) and 82.4 percent achieved an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) (IGA 0/1).1 Among patients in the combined* guselkumab group, patients were either initially randomised to guselkumab or to placebo with crossover to guselkumab at week 16.1 Safety outcomes were observed through 264 weeks with no new safety signals.1,2 Guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor.2 These data are being presented at the 16th Annual Coastal Dermatology Symposium, which will be conducted virtually.1
“Patients with psoriasis face a life-long struggle as a result of this complex and disabling chronic disease," said Chris Griffiths,** M.D., Dermatology Centre, University of Manchester, Manchester, UK. “The VOYAGE 1 guselkumab data are the first for an IL-23 p19 inhibitor to demonstrate skin clearance for the majority of patients through nearly five years of treatment and are encouraging for patients and physicians alike as they seek long-term treatment options.”
In this Phase 3 trial, out of a total of 494 patients either randomised to guselkumab at week 0 (n=329) or randomised to placebo and crossed over to receive guselkumab at week 16 (n=165), 76.9 percent (380/494) continued on guselkumab treatment through week 252. Through nearly five years of continuous guselkumab use, PASI 90 response rates were steadily consistent based on the primary pre-specified Treatment Failure Rules (TFR). At week 52, PASI 90 response rates were 79.7 percent, 75.5 percent, and 80.6 percent based on TFR, Non-Responder Imputation (NRI), and As Observed (OBS) analyses, respectively; while corresponding rates at week 252 were 84.1 percent, 66.6 percent, and 86.6 percent. Similarly, PASI 100, IGA 0/1, and IGA 0 response rates were consistent from week 52 through week 252. Response rates were also consistent through week 252 in patients randomised to guselkumab at week 0 (n=329). Of note, each patient may not have achieved response at each observation time point. At one year and thereafter, patients and study investigators knew that all study participants were on guselkumab, which may affect the results.1
Safety findings were generally consistent with those previously observed and the current Summary of Product Characteristics.1,2 Through the end of the safety assessment (week 264) for all patients (n=774) inclusive of the combined* guselkumab group (n=494) and a group of patients initially treated with adalimumab who crossed over to guselkumab (n=280), the proportion of patients reporting at least one adverse event (AE), serious AE, or discontinuation due to AEs were 87.7 percent, 16.4 percent, and 6.1 percent, respectively.1 Very common (≥10 percent) and common AEs (≥1 percent) in controlled periods of clinical studies with guselkumab were upper respiratory infections, gastroenteritis, herpes simplex infections, tinea infections, headache, diarrhoea, urticaria, arthralgia and injection site reactions. Uncommon AEs (≥0.1 percent) observed were hypersensitivity, anaphylaxis and rash.2
“We are excited to share these data demonstrating guselkumab’s ability to help adults living with moderate to severe plaque psoriasis by providing sustained rates of clearance through nearly five years for the majority of patients,” said Lloyd Miller, M.D., Ph.D., Vice President, Immunodermatology Disease Area Leader, Janssen Research & Development, LLC. “With remission as the ultimate goal, we are committed to continuing to apply the best science and disease insights to advancing therapies that improve the lives of patients.”
#ENDS#
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.3 The inconsistent nature of psoriasis means that even when plaques appear to subside, patients can have ongoing concerns over their return.4
Impact
Approximately 14 million people in Europe are living with psoriasis, which often leads to a great physical and psychological burden.5 Mental health issues are common among people with psoriasis, and the impact it can have on quality of life is comparable with diabetes and cancer.6 Psoriasis is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder (COPD) and osteoporosis.7 In addition, many individuals face social exclusion, discrimination and stigma because of their disease.8
About VOYAGE 1 (NCT02207231)1
This Phase 3, randomised, double-blind, placebo and active comparator-controlled trial with 837 patients was designed to evaluate the efficacy and safety of guselkumab compared with placebo and adalimumab in adults with moderate to severe plaque psoriasis. Patients were randomised to receive placebo (n=174) at weeks 0, 4 and 12, followed by crossover to guselkumab (n=165) at weeks 16 and 20 followed by every eight-week (q8w) dosing; guselkumab 100 mg (n=329) at weeks 0, 4 and 12, followed by q8w dosing; or adalimumab 80 mg (n= 334) at week 0, followed by 40 mg at week 1, then dosing every two weeks through week 47, with crossover to guselkumab q8w at week 52.
The co-primary endpoints of the study were the proportions of patients receiving guselkumab vs. patients receiving placebo achieving IGA 0/1 (clear/almost clear) [73 percent vs. 3 percent p<0.001 vs placebo ] and PASI 90 [85 percent vs. 7 percent p<0.001 vs placebo ] at week 16. Secondary endpoints were assessed at weeks 16, 24 and 48, with safety monitoring throughout the study. Through week 48, NRI rules were used for missing data (after the application of treatment failure rules).
During the open-label extension period, which started at week 52, all patients continued open-label treatment with guselkumab through week 252. Efficacy assessments included proportions of patients achieving PASI 90, PASI 100, IGA of 0/1, and IGA of 0. Efficacy was analysed using prespecified TFR for the primary analysis, while NRI and OBS methodologies were used for the secondary analyses.
VOYAGE 1 and VOYAGE 2 are part of a comprehensive Phase 3 clinical development program for guselkumab in psoriasis that includes an additional Phase 3 trial, NAVIGATE, and ECLIPSE, the first head-to-head Phase 3 study of an IL-23 inhibitor (guselkumab) vs. an IL-17 inhibitor (secukinumab).9,10
About TREMFYA® (guselkumab)
Developed by Janssen, guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.2 Guselkumab is approved in the European Union (EU), US, Canada, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet [UV] light).2 It is approved in the US, Canada, Japan, Brazil and Ecuador for the treatment of adult patients with active psoriatic arthritis.2 IL-23 is an important driver of the pathogenesis of inflammatory immune-mediated diseases such as psoriasis.11 In psoriasis, guselkumab is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4.2
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA® .
Important Safety Information2
Very common (≥10 percent) and common AEs (≥1 percent) in controlled periods of clinical studies with guselkumab were upper respiratory infections, gastroenteritis, herpes simplex infections, tinea infections, headache, diarrhoea, urticaria, arthralgia and injection site reactions. Uncommon AEs (≥0.1 percent) were hypersensitivity, anaphylaxis and rash. Most were considered to be mild and did not necessitate discontinuation of study treatment.
Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab: https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya#product-information-section .
▼ AEs should be reported. This medicinal product is subject to additional monitoring and it is, therefore, important to report any suspected AEs 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. AEs should also be reported to Janssen-Cilag Ltd on 01494 567447.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com/emea
.
Follow us at www.twitter.com/JanssenEMEA
.
Janssen-Cilag International NV, the marketing authorisation holder for TREMFYA® in the EU, and Janssen Research & Development, LLC, are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
*
The combined group included patients who were initially randomised to receive TREMFYA at week 0 and patients who were initially randomised to placebo then crossed over to TREMFYA at week 16.
**
Professor Griffiths is a paid consultant for Janssen. He was not compensated for any media work.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding ongoing and planned development efforts involving TREMFYA® (guselkumab) as a treatment for adult patients with moderate to severe plaque psoriasis. 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 materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; 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 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent 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
- Griffiths C, et al. Maintenance of Response Through 5 Years of Continuous Guselkumab Treatment: Results from the Phase 3 VOYAGE 1 Trial. Presented at the Coastal Dermatology Symposium Virtual Meeting Experience October 15–16, 2020.
- European Medicines Agency. TREMFYA Summary of Product Characteristics. 2019. Available at: https://www.medicines.org.uk/emc/medicine/34321 . Accessed October 2020.
- Mayo Clinic. Psoriasis Overview. Available at: https://www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840. Accessed October 2020.
- Clark RA. Resident memory T cells in Human Health and Disease. Sci Transl Med 2015;7:269rv1.
- Ortonne J and Prinz J. Alefacept: A Novel and Selective Biologic Agent for the Treatment of Chronic Psoriasis. Eur J Dermatol 2004;14:41–45.
- Rapp S, Feldman S, et al . Psoriasis Causes as much Disability as Other Major Medical Diseases. J Am Acad Dermatol 1999;41:401–407.
- Nijsten T and Wakkee M. Complexity of the Association Between Psoriasis and Comorbidities. J Am Acad Dermatol 2009;129:1601–1603.
- World Health Organization. Global Report on Psoriasis. 2016. Available at: apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf . Accessed October 2020.
- Clinicaltrials.gov. A Study of Guselkumab in Participants with Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab (NAVIGATE). Identifier NCT02203032. Available at: https://clinicaltrials.gov/ct2/show/NCT02203032 . Accessed October 2020
- 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 2020.
- Benson J, et al . Discovery and Mechanism of Ustekinumab. MAbs 2011;3:535–45.
October 2020 CP-184034
View source version on businesswire.com: https://www.businesswire.com/news/home/20201015005516/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SCENTMATIC's AI "KAORIUM" Debuts at THAMEEN Fragrance Launch in London's Selfridges4.7.2025 11:13:00 CEST | Press release
SCENTMATIC Inc., a leader in scent digitalization, introduced its AI-powered scent-to-language system, KAORIUM, at the THAMEEN Fragrance new product launch event. This pivotal event took place from June 5 to 11, 2025, at Selfridges department store in London, UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703662207/en/ State of exhibition Global Expansion: KAORIUM Establishes UK Presence Europe leads the global fragrance market, with the UK projected to reach US$2.82 billion by 2033. Recognizing this, SCENTMATIC is rapidly expanding its international footprint. In May 2024, SCENTMATIC established its overseas subsidiary, KAORIUM, in London, appointing industry expert Ben Yanoushek as CEO. Official UK operations commenced on February 1, 2025, with the launch of its dedicated website: www.kaorium.com. KAORIUM Trialed at "Florentine Diamond" Launch Event The "Florentine Diamond" launch event for luxury brand THAMEEN Frag
Andersen Consulting samarbejder med Mercurial Minds om at forbedre mulighederne inden for digital transformation4.7.2025 01:10:00 CEST | Pressemeddelelse
Andersen Consulting udvider sit udbud af teknologidrevne løsninger med tilføjelsen af samarbejdsfirmaet Mercurial Minds (M.M.), et konsulentfirma inden for digital transformation, AI og IT med base i Pakistan. M.M. blev grundlagt i 2013 og tilbyder en række tjenester, der er designet til at hjælpe organisationer med at udvikle sig og skalere, herunder i forbindelse med deres digitale transformationsstrategi, AI-tjenester, it-rådgivning og udvikling af robuste mobil- og webbrugeroplevelser. Firmaet leverer end-to-end-løsninger – udformning af datadrevne køreplaner, udvikling af intelligent automatisering og levering af sikre mobil- og weboplevelser, der kan skaleres – skræddersyet til virksomheder, der ønsker at forbedre sine forbindelsesmulighederne og opnå indsigter i realtid. M.M. betjener en bred vifte af brancher med fokus på finans, telekommunikation og andre dataintensive sektorer. "Dette samarbejde er en katalysator," siger Nabeel Saiyer, administrerende direktør for M.M. "Vores
Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 01:00:00 CEST | Press release
The World Economic Forum report, in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, predicts a significant uptick in tourist trips across the globeThe tourism sector will contribute $16 trillion to global GDP (more than 11% of the global economy) by 2034, according to World Travel & Tourism Council estimates (WTTC)India and China will be responsible for more than 25% of all outbound travel by 2030 The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster th
The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 21:00:00 CEST | Press release
The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate
Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 14:59:00 CEST | Press release
Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom