Janssen Presents New Four-Year TREMFYA® (guselkumab) Data Demonstrating Maintained Rates of Skin Clearance in Adult Patients with Moderate to Severe Plaque Psoriasis

LAS VEGAS, Oct. 17, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new long-term data from the open-label period of the Phase 3 VOYAGE 1 clinical trial. These data showed that 82 percent of patients receiving TREMFYA^® (guselkumab) in the combined group of patients initially randomized to TREMFYA or to placebo with crossover to TREMFYA at week 16 achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90) response and an Investigator's Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 204 (4 years). TREMFYA is the first monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor to have been approved by the U.S. Food and Drug Administration (FDA). The data are being presented at the 39th Fall Clinical Dermatology Conference in Las Vegas, Nevada.

"Dermatologists and psoriasis patients benefit from long-term efficacy and safety studies like VOYAGE 1. When approaching treatment for a lifelong, chronic condition like psoriasis, it's important to be informed about how available medicines work over time," said Andrew Blauvelt, M.D., MBA, President, Oregon Medical Research Center, and VOYAGE 1 study steering committee member.^* "These findings demonstrated maintenance of PASI 90 and IGA 0/1 response rates for four years in adults with moderate-to-severe plaque psoriasis."

Additional results from the open-label extension of the VOYAGE 1 Phase 3 clinical study showed that PASI 100, IGA 0/1, and IGA 0 clear skin responses were consistent at week 52 and week 204 in the combined group of patients initially randomized to TREMFYA or to placebo with crossover to TREMFYA at week 16. Proportions of patients with Psoriasis Symptoms and Signs Diary (PSSD) symptom scores of 0 (no symptoms of psoriasis) were consistent at week 76 and week 204. No new safety signals were identified.

"We are excited about these findings as they provide additional data for TREMFYA over time in adults living with plaque psoriasis," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "In our ongoing commitment to psoriasis patients, we are not only directing efforts towards the discovery and development of new treatment options for dermatologic conditions, we are also recognizing the importance of observing therapies like TREMFYA over the long-term."

About Psoriasis
Psoriasis is an immune-mediated disease resulting in an overproduction of skin cells which cause raised, red, scaly plaques that may be itchy or painful.¹ It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.² Nearly one-quarter of all people with psoriasis have cases that are considered moderate to severe.²

About VOYAGE 1
This 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 (q8w) dosing; TREMFYA^® 100 mg at weeks 0, 4 and 12, followed by q8w dosing; 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) [73% vs 3% P<0.001 vs placebo] and PASI 90 [85% vs 7% 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, non-responder imputation rules were used for missing data (after the application of treatment failure rules). After week 48, treatment failure rules only were applied in the primary analysis.

During the open-label extension period, which started at week 52 and is currently ongoing, all patients in the combined TREMFYA^® group continued open-label treatment with TREMFYA^® through week 204. Efficacy assessments included proportions of patients achieving Psoriasis Area and Severity Index (PASI) 90, PASI 100, Investigator Global Assessment (IGA) of 0/1, and IGA of 0. Efficacy was analyzed using prespecified treatment failure rules (TFR), nonresponder imputation (NRI), and As Observed (OBS) methodology.

VOYAGE 1 is part of a comprehensive TREMFYA^® Phase 3 clinical development program in psoriasis that includes two additional Phase 3 trials, VOYAGE 2 and NAVIGATE, as well as ECLIPSE, which is a Phase 3b study of TREMFYA^® vs. secukinumab.

About TREMFYA^® (guselkumab)
Developed by Janssen, TREMFYA^® is a human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor, and is approved in the U.S., Canada, the European Union, Japan and a number of other countries worldwide 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 [UV] light). IL-23 is an important driver of the pathogenesis of inflammatory diseases such as psoriasis. The TREMFYA^® development program includes: two Phase 3 studies evaluating TREMFYA^® in the treatment of active psoriatic arthritis, a Phase 2b/3 program in Crohn's disease, a Phase 2b/3 program in Ulcerative Colitis, and two other Phase 2 studies – one exploring biologic combination therapy in 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^®.

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

Do not take TREMFYA^® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA^®.

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^®?"

Serious Allergic Reactions
Stop using TREMFYA^® and get emergency medical help right away if you have any of the following symptoms of a serious allergic reaction: feel faint, swelling of your face, eyelids, lips, mouth, tongue or throat, trouble breathing or throat tightness, chest tightness, or skin rash, hives.

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.

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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. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Scientific Affairs, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

*Dr. Blauvelt 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 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 December 30, 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. National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis. Accessed October 2019.
^2. National Psoriasis Foundation. Statistics. https://www.psoriasis.org/content/statistics. Accessed October 2019.

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SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson

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