New TREMFYA® (guselkumab) Data Demonstrates Long-Term Skin Clearance In Patients With Moderate To Severe Plaque Psoriasis

SAN DIEGO, Feb. 16, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data that showed a vast majority of patients with moderate to severe plaque psoriasis receiving TREMFYA^® (guselkumab) who achieved at least 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28, maintained a PASI 90 response with continuous treatment through week 72. Findings from the study also demonstrated that a vast majority of patients originally randomized to TREMFYA, but withdrawn from treatment at week 28, regained a PASI 90 response within six months of initiating TREMFYA retreatment. These long-term findings from the Phase 3 VOYAGE 2 study will be presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California during a late-breaking abstract session at 1:00 PM PST on Saturday, February 17. TREMFYA is a first-in-class approved biologic therapy that selectively blocks interleukin (IL)-23 and is administered as a 100-mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4.

"The longer-term data from VOYAGE 2 show promising results for guselkumab as both a continuous, long-term treatment for moderate to severe plaque psoriasis, and as an option for patients who have been withdrawn from therapy and retreated," said study investigator Prof. Kristian Reich, M.D. of Dermatologikum Berlin and SCIderm Research Institute in Hamburg, Germany. "These data provide important information to dermatologists should they need to interrupt treatment with guselkumab for a period of time, as the findings demonstrate guselkumab quickly and robustly re-established a PASI 90 response within six months."

Results from the trial demonstrated that among patients who achieved PASI 90 response at week 28 with TREMFYA, 86 percent who continued receiving TREMFYA maintained a PASI 90 response through week 72, while only 11.5 percent of patients who were withdrawn from treatment maintained PASI 90 response. Of 173 patients who lost PASI 90 response after withdrawal from TREMFYA, 87.6 percent recaptured PASI 90 response six months following re-treatment. No new safety signals were observed with continuous treatment or retreatment therapy with TREMFYA through week 100.

"To see a large majority of patients in both treatment groups achieve almost clear skin with no new safety events further supports the importance of TREMFYA in the treatment of moderate to severe plaque psoriasis," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "These data are especially important in further understanding the role IL-23 plays in the onset and progression of plaque psoriasis, unique insights that we continue to apply in our innovation efforts with TREMFYA and the IL-23 pathway."

TREMFYA data from eight additional abstracts will be presented at the AAD Annual Meeting, including an oral presentation of a pooled analysis from the Phase 3 VOYAGE 1 and 2 trials evaluating consistency of response by weight across subgroups of patients through week 24.

"Janssen continues to pursue transformational treatments for patients with chronic immune diseases such as psoriasis," said Mathai Mammen, M.D., Ph.D., Global Head, Research and Development, Janssen Research & Development, LLC. "We seek to understand what immunological conditions are driven through the IL-23 axis, and look for opportunities to meaningfully improve the lives of patients through the use of our innovative medicines."

About Voyage 2
The Phase 3 VOYAGE 2 trial is a randomized, double-blind, placebo- and active-comparator-controlled study designed to evaluate the safety and efficacy of TREMFYA^® compared with placebo and adalimumab and of TREMFYA maintenance therapy compared with withdrawal of therapy in adult patients with moderate to severe plaque psoriasis. Patients (n=992) were randomized to receive subcutaneous (SC) injections of TREMFYA 100 mg at weeks 0, 4, 12 and 20; placebo at weeks 0, 4, and 12 with crossover to TREMFYA at weeks 16 and 20 or adalimumab 80 mg at week 0, followed by 40 mg at week 1 and every two weeks through week 23. Patients initially randomized to receive TREMFYA who achieved a PASI 90 response (n=375) at week 28 were re-randomized to either continued treatment with TREMFYA (n=193) or withdrawal to placebo (n=182) with retreatment upon a 50 percent or greater loss of PASI improvement at week 28 or week 72 if retreatment criteria were not met.  

About TREMFYA^® (guselkumab)
TREMFYA^® is a human monoclonal antibody developed by Janssen that selectively blocks the protein interleukin (IL)-23 and is approved in the U.S., Canada and Europe for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).  A Phase 3 program evaluating TREMFYA in the treatment of active psoriatic arthritis is ongoing, a Phase 3 study evaluating the efficacy of TREMFYA compared with Cosentyx^® (secukinumab) in the treatment of moderate to severe plaque psoriasis is underway and a Phase 3 program in Crohn's disease is planned.

Applications seeking approval of TREMFYA are currently under review worldwide including Japan.

TREMFYA is a trademark of Janssen Biotech, Inc.  

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TREMFYA^®?
TREMFYA^® may cause serious side effects, including infections. TREMFYA^® is a prescription medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA^® and may treat you for TB before you begin treatment with TREMFYA^® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA^®.

• Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
• fever, sweats, or chills
• muscle aches
• weight loss
• cough
• warm, red, or painful skin or sores on your body different from your psoriasis
• diarrhea or stomach pain
• shortness of breath
• blood in your phlegm (mucus)
• burning when you urinate or urinating more often than normal

Before using TREMFYA^®, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA^®?"
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA^®.
• are pregnant or plan to become pregnant. It is not known if TREMFYA^® can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if TREMFYA^® passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of TREMFYA^®?
TREMFYA^® may cause serious side effects. See "What is the most important information I should know about TREMFYA^®?"

The most common side effects of TREMFYA^® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, and herpes simplex infections.

These are not all the possible side effects of TREMFYA^®. Call your doctor for medical advice about side effects.

Use TREMFYA^® exactly as your healthcare provider tells you to use it.

Please read the full Prescribing Information, including Medication Guide for TREMFYA^®, and discuss any questions that you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

075142-170622

About Psoriasis
Psoriasis is a chronic, inflammatory autoimmune disorder that results in the overproduction of skin cells, characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain. It is estimated that as many as 125 million people worldwide have psoriasis, including more than 8 million Americans and 14 million Europeans.^1-7 The disease symptoms can range from mild, to moderate, to severe and disabling. It is estimated that nearly three percent of the world's population is living with psoriasis.⁵

About the Janssen Pharmaceutical Companies
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. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC and Janssen Biotech, Inc. 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 ongoing and planned development efforts involving TREMFYA^® and the IL-23 pathway. 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, Janssen Biotech, Inc. 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; competition, including technological advances, new products and patents attained by competitors; challenges to patents; manufacturing difficulties or delays; product efficacy or safety concerns resulting in product recalls or regulatory action; 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 1, 2017, including under "Item 1A. Risk Factors," its most recently filed Quarterly Report on Form 10-Q, including in the section captioned "Cautionary Note Regarding Forward-Looking Statements," 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 or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Humira^® is a registered trademark of AbbVie Inc.

References

1. National Psoriasis Foundation. People of All Races Overcome Psoriatic Disease. https://www.psoriasis.org/advance/features/people-of-all-races-overcome-the-challenge-of-psoriatic-diseases. Accessed January 30, 2018.
2. National Psoriasis Foundation. Psoriasis Fact Sheet. https://www.psoriasis.org/sites/default/files/psoriasis_fact_sheet.pdf. Accessed January 30, 2018.
3. National Psoriasis Foundation. Advocacy Toolkit. https://www.psoriasis.org/toolkit/the-burden-of-psoriatic-diseases. Accessed January 30, 2018.
4. Augustin M, et al. Prevalence of skin lesions and need for treatment in a cohort of 90 880 workers. Br J Dermatol 2011;165:865–873.
5. Healthline. Psoriasis by the Numbers: Facts, Statistics, and You. https://www.healthline.com/health/psoriasis/facts-statistics-infographic#prevalence. Accessed January 30, 2018.
6. Parisi R, et al. Global Epidemiology of Psoriasis: A Systematic Review. J Invest Dermatol 2013;133:377–385.
7. World Population statistics. Population of Europe 2014. http://www.worldpopulationstatistics.com/population-of-europe-2014. Accessed January 30, 2018.

SOURCE Janssen Pharmaceutical Companies

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