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Johnson & Johnson - Latest Phase 3 Data for First-in-Class TREMFYA Demonstrates Significant and Durable Improvement in Signs and Symptoms of Active Psoriatic Arthritis

12/06/2021 | 04:28am EST

SPRING HOUSE - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new TREMFYA (guselkumab) efficacy and safety data from the Phase 3b COSMOS trial published in Annals of the Rheumatic Diseases (ARD), evaluating this selective interleukin (IL)-23

inhibitor in adults with active psoriatic arthritis (PsA) who demonstrated inadequate efficacy or intolerance to tumor necrosis factor inhibition (TNFi).1 Results showed significantly higher proportions of patients treated with TREMFYA had improvement in joint signs and symptoms and complete skin clearance versus placebo at week 24 in this documented TNFi-IRa patient population, which is often more difficult to treat.1

Furthermore, improvements in signs and symptoms of PsA were maintained or numerically increased through one year (week 48) among TREMFYA-randomized patients.1

'Active psoriatic arthritis is a heterogenous disease and a significant number of patients do not respond adequately to TNF inhibition,' said lead author Laura Coates, M.D., Ph.D., Associate Professor, University of Oxford, UK.b 'The COSMOS data demonstrate that TREMFYA significantly improved signs and symptoms of active psoriatic arthritis across multiple clinical disease domains, including patient reported outcomes, with treatment effects observed by week four. These findings reinforce the utility of this alternative mechanism of action as a therapeutic option for adults with active psoriatic arthritis who have not responded to one or more therapies.'

About Active Psoriatic Arthritis (PsA)

Active PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (severe inflammation of the fingers and toes), axial disease, and the skin lesions associated with plaque PsO.11-13 In addition, in patients with active PsA, comorbidities, such as obesity, cardiovascular diseases, anxiety and depression are often present.14 Studies show up to 30 percent of people with plaque PsO also develop active PsA.14 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any time.15

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.

Cautions Concerning Forward-Looking Statements

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA (guselkumab) product development. 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 behavior 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 January 3, 2021, 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


Bridget Kimmel

Tel: (215) 688-6033

(C) 2021 Electronic News Publishing, source ENP Newswire

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