JANSSEN
14.6.2019 13:41:04 CEST | Business Wire | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20% improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER programme were consistent with previous studies of guselkumab and current prescribing information.1
The DISCOVER programme comprises the first-ever Phase 3 studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis, and data will be presented at upcoming scientific medical meetings. Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year.
The DISCOVER programme consists of DISCOVER-1 and DISCOVER-2, two randomised, double-blind, multicentre Phase 3 studies designed to evaluate efficacy and safety of subcutaneous guselkumab in patients with active PsA compared to placebo. In addition to the primary endpoint of ACR20 response at week 24, multiple secondary endpoints were assessed that included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), and quality of life (SF-36 PCS and MCS). DISCOVER-2 also assessed effect on structural damage (vdH-S) as a key secondary endpoint.1
DISCOVER-1 included 381 participants, including participants previously treated with biologic anti-TNF biologics. The study continues through 52 weeks. DISCOVER-2 included 739 bio-naive participants and continues through 100 weeks.
#ENDS#
About Psoriatic Arthritis (PsA)
PsA is a chronic, immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis.2 It is estimated that one third of the 125 million people who are living with psoriasis worldwide will also develop PsA.3 The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time.2 Though the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.2
About guselkumab 4
On 10 November 2017, TREMFYA® (guselkumab) was granted market authorisation in the European Union (EU) for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy).4
Guselkumab is the first psoriasis treatment licensed in the EU to selectively target IL-23, a key driver of the immune inflammatory response in psoriasis.5,6,7,8 Guselkumab 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.5,6,9
Ongoing trials include: two Phase 3 programmes evaluating guselkumab in the treatment of active PsA and a Phase 2b programmes in Crohn’s disease, and two Phase 2 programmes – one for the treatment of ulcerative colitis and the other for the treatment of hidradenitis suppurativa.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA® which is currently approved in the US, Canada and the EU.
Prescribing and safety information
For complete EU prescribing and safety information, please visit: https://www.medicines.org.uk/emc/medicine/34321
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.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding new study data on 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 and Janssen Research & Development, LLC. 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 30 December, 2018, 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.
# # #
1 Janssen Pharmaceutical Companies of Johnson & Johnson. Data on file (2019).
2 Mayo Clinic. Psoriatic Arthritis. http://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/home/ovc-20233896 . Accessed June 2019.
3 International Federation of Psoriasis Associations. Our Cause: Psoriasis. Available at: https://ifpa-pso.com/our-cause/ . Accessed June 2019.
4 European Medicines Agency. Tremfya 100mg solution for injection. 2017. Available at: https://www.medicines.org.uk/emc/medicine/34321 . Accessed June 2019.
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 Bachelez, H. Interleukin 23 inhibitors for psoriasis: not just another number. The Lancet 2017;390(10091):208–10.
9 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 June 2019.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190614005203/en/
Contact:
Media Contact: Emily Bone Phone: +44 787-639-4360 ebone1@its.jnj.com
Investor Relations: Christopher DelOrefice Phone: +1 732-524-2955
Lesley Fishman Phone: +1 732-524-3922
Link:
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
OpenRouter Raises $113 Million CapitalG-led Series B as Weekly Volume Explodes to 25T Tokens26.5.2026 15:15:00 CEST | Press release
NVentures, ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures join CapitalG, a16z, Menlo Ventures, and others in backing the high-growth AI infrastructure startup OpenRouter, the AI model exchange, today announced a $113 million Series B led by Alphabet’s independent growth fund, CapitalG, with participation from investors including NVentures (NVIDIA’s venture capital arm), ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures, alongside existing investors including Andreessen Horowitz and Menlo Ventures. OpenRouter’s volume has surged to 25 trillion tokens per week (100 trillion tokens per month), representing a 5X increase from the 5 trillion tokens processed per week just six months ago. The explosion in token demand illustrates how quickly enterprises are deploying agents and scaling AI across multiple models and providers. OpenRouter’s infrastructure manages and optimizes inference and provides access to 400+ models across leadi
Xsolla Expands Its Community Management Tools for Creators, Community Leaders, and Resellers26.5.2026 15:00:00 CEST | Press release
Xsolla Adds New Features For Creators, Community Leader Experience, And Distinct Channels For Emerging Markets Xsolla, a leading global video game commerce company, today announced three simultaneous expansions of its community management tools and products. As the creator economy continues to reshape how games are discovered and the industry accelerates its shift toward direct-to-consumer commerce, Xsolla is building on its community management tools for creators, community leaders, and emerging markets, and will showcase them at TwitchCon Rotterdam later this month. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526596720/en/ Graphic: Xsolla The games industry has never had a shortage of people who drive player acquisition, loyalty, and commerce; it's had a shortage of infrastructure that recognizes them. Creators stream it. Community leaders build a culture around it. Local resellers get it into the hands of players in
Biocytogen Launches AI-Powered RenSuper™ Platform and Industry-First Fully Automated Antibody Discovery Infrastructure26.5.2026 14:00:00 CEST | Press release
Biocytogen today announced the launch of RenSuper Workstation, a next-generation AI-powered antibody discovery platform providing off-the-shelf access to a large-scale, experimentally validated library of fully human therapeutic antibody sequences, together with the RenSuper High-Throughput Antibody Manufacturing Automation Center, a fully automated infrastructure designed to accelerate antibody validation and production. Built on Biocytogen’s proprietary RenMice® platforms, RenSuper establishes a closed-loop antibody discovery engine combining in vivo immune repertoires, AI-driven candidate selection, automated experimental validation, and scalable manufacturing infrastructure. The platform supports the discovery and development of monoclonal antibodies, bispecifics, multispecifics, antibody-drug conjugates (ADCs), VHHs, and other advanced therapeutic modalities, significantly reducing the time and risk associated with antibody discovery. RenSuper Workstation: AI-Powered One-Click Tar
ViaLase Announces Global Commercial Introduction of the FLIGHT Procedure26.5.2026 14:00:00 CEST | Press release
First commercial femtosecond laser image-guided, high precision trabeculotomy (FLIGHT) treatments mark a new era in interventional glaucoma; one where precision, safety, and the patient experience define the new standard of care ViaLase, Inc., a commercial stage medical technology company pioneering incision-free, laser-based solutions for glaucoma, today announced the successful completion of the first commercial FLIGHT procedures performed at Centre for Sight in London by Sheraz Daya, MD, and Gus Gazzard, MD, and at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany, by Karsten Klabe, MD. The first commercial FLIGHT procedures were performed using the ViaLuxe® Laser System to deliver an incision-free, image-guided femtosecond laser treatment designed to create precise channels through the trabecular meshwork to restore aqueous outflow and reduce intraocular pressure in patients with open-angle glaucoma. “Centre for Sight has always been committed to bringing meaningful inno
BioIVT to Spotlight ADME-Tox Expertise and Solutions at Summer 2026 Events26.5.2026 14:00:00 CEST | Press release
Company will demonstrate how high-quality, well-characterized biospecimens are critical to the success of both new approach methodologies (NAMs) and traditional studies BioIVT, the leading biospecimen solutions provider and global research partner for drug and diagnostic development, today announced it will showcase its broad portfolio of ADME-Tox solutions and research expertise at several leading industry events, including the 2026 MPS World Summit and the ISSX 16th European Meeting. The MPS World Summit takes place May 26-May 29, 2026, in Washington, D.C. BioIVT colleagues will be available at booth #115 to discuss research questions and needs, including preparation, handling, and utilization of the high-quality tissues and cells needed for microphysiological systems (MPS), as well as conducting ADME studies and bioanalysis. BioIVT offers an extensive range of control and disease state biospecimens, including SPHEROID CERTIFIED™ Hepatocytes as well as advanced HEPATOPAC® co-cultures
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