New Two-Year TREMFYA™ (guselkumab) Data Show Patients With Moderate To Severe Plaque Psoriasis Achieved Consistent Rates Of Skin Clearance

GENEVA, Sept. 16, 2017 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) presented today new longer-term data from the open-label extension of the VOYAGE 1 trial demonstrating consistent rates of skin clearance with TREMFYA™ treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody.  The longer-term findings from the Phase 3 VOYAGE 1 study presented at the 26^th European Academy of Dermatology and Venereology (EADV) Congress showed more than 80 percent of patients receiving TREMFYA™, including those initially treated with placebo or the anti-tumor necrosis factor (TNF)-alpha agent Humira^® (adalimumab) achieved 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 100.  The findings, presented during an EADV late-breaker session, follow the recent European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of TREMFYA™, and the United States Food and Drug Administration (FDA) approval of TREMFYA™ in July.  

"These data show the rates of skin clearance with guselkumab were consistent at weeks 52 and 100 with every eight-week maintenance therapy.  These important new findings contribute to the scientific evidence for targeting IL-23 in the treatment of moderate to severe plaque psoriasis," said Professor Chris Griffiths, Foundation Professor of Dermatology at the University of Manchester, UK, VOYAGE 1 study steering committee member.  "Also noteworthy is that skin clearance rates in patients transitioned to guselkumab from adalimumab improved and the rates were consistent at weeks 52 and 100."

Results from the open-label extension of the Phase 3 VOYAGE 1 study showed that at week 100, among patients initially randomized to TREMFYA™, 82.4 percent achieved an IGA score of 0/1 (cleared or minimal disease) and 82.1 percent achieved a PASI 90 score (near complete skin clearance).  In addition, at week 100, 53.8 percent of patients achieved an IGA score of 0 and 49.0 percent of patients achieved a PASI 100 score.  These measures represent skin completely cleared of plaques and were consistent with PASI 100 and IGA 0 results demonstrated at week 52.  Among patients initially randomized to receive adalimumab and transitioned to TREMFYA™ at week 52, the proportion of patients achieving a PASI 90 score increased from 50.5 percent at week 52 to 81.1 percent at week 100, and the proportion of patients achieving an IGA 0/1 increased from 60.4 percent at week 52 to 84 percent at week 100.  The proportion of patients who achieved PASI 100 and IGA 0 scores increased from 24 percent and 27.3 percent, respectively, at week 52 to 51.6 percent and 55.6 percent, respectively, at week 100.  Results among patients initially randomized to placebo and crossed over to TREMFYA™ at weeks 16 and 20 demonstrated consistent levels of skin clearance at weeks 52 and 100.

Scores from the Psoriasis Symptoms and Signs Diary (PSSD), which 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), were consistent over the two-year period with TREMFYA™ treatment.  Patients initially randomized to receive adalimumab therapy in VOYAGE 1 and crossed over to TREMFYA™ demonstrated substantial improvement in PSSD scores from week 48 to week 100.  The proportion of patients reporting PSSD symptom scores of 0 (0-10 scale where a higher score indicates more severe symptoms of psoriasis) improved from 23.1 at week 48 (during adalimumab treatment) to 41.8 percent at week 100 (during TREMFYA™ treatment). 

The adverse events (AEs), serious AEs and infections per 100 patient-years of follow-up through week 100 among the placebo crossover to TREMFYA group and the initial TREMFYA group combined were 220.30, 6.5 and 87.77, respectively, which were consistent with those through week 48 (282.12, 5.84 and 110.97, respectively).  No cases of active tuberculosis, opportunistic infections or serious hypersensitivity reactions were reported.

"We are committed to advancing innovative therapies for immune-mediated diseases, like psoriasis, as we seek to improve outcomes for patients," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC.  "We look forward to continued collaborations with regulators as we work to bring TREMFYA™ to patients around the world who may benefit from this novel therapy."

An additional eight abstracts presented during EADV reported on efficacy, safety and patient-reported outcome data from the TREMFYA™ Phase 3 moderate to severe plaque psoriasis clinical development program.

About VOYAGE 1
The Phase 3, randomized, double-blind, placebo and active comparator-controlled trial was designed to evaluate the efficacy and safety of TREMFYA™ compared with placebo and adalimumab in adults with moderate to severe plaque psoriasis.  Patients (n=837) were randomized to receive placebo at weeks 0, 4 and 12, followed by crossover to TREMFYA™ at weeks 16 and 20 followed by every eight-week dosing (q8w); TREMFYA™ 100 mg at weeks 0, 4 and 12, followed by q8w; or adalimumab 80 mg at week 0 and 40 mg at week 1, followed by every two-week dosing through week 47, with crossover to TREMFYA™ q8w at week 52. The co-primary endpoints of the study were the proportions of patients receiving TREMFYA™ versus patients receiving placebo achieving IGA 0/1 (cleared/minimal disease) and PASI 90 response at week 16.  Secondary endpoints were assessed at weeks 16, 24 and 48, with safety monitoring throughout the study.  The open-label extension period started at week 52 and is currently ongoing.  Results presented to date include findings through week 100 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.  VOYAGE 1 is part of a comprehensive TREMFYA™ Phase 3 clinical development program that includes two additional Phase 3 trials, VOYAGE 2 and NAVIGATE.

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. 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.

The final European Commission decision on the approval of TREMFYA™ is expected by the end of 2017.  Applications seeking approval in Japan and other countries are currently under review.

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
• diarrhea or stomach pain
• warm, red, or painful skin or sores on your body different from your psoriasis
• cough
• 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, autoimmune inflammatory 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 on Twitter at https://twitter.com/JanssenGlobal.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, regarding the continued development and potential expanded use of TREMFYA™. 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 and 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 August 22, 2017.
2. National Psoriasis Foundation. Psoriasis Fact Sheet. https://www.psoriasis.org/sites/default/files/psoriasis_fact_sheet.pdf. Accessed August 22, 2017.
3. National Psoriasis Foundation. Advocacy Toolkit. https://www.psoriasis.org/toolkit/the-burden-of-psoriatic-diseases. Accessed August 24, 2017.
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. Ortonne J, et al. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol 2004;14:41–45.
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 August 22, 2017.

SOURCE Janssen Research & Development, LLC

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