Janssen’s New Phase II Data Show Treatment With TREMFYA (guselkumab) Improved Psoriatic Arthritis Symptoms Through One Year

SAN DIEGO, Nov. 7, 2017 /PRNewswire/ -- Janssen Research & Development announced today longer-term results from a Phase 2 study investigating TREMFYA^® (guselkumab), the first selective anti-interleukin (IL)-23 monoclonal antibody to show positive results in the treatment of active psoriatic arthritis. According to findings presented at the 2017 ACR/ARHP Annual Meeting, more than 70 percent of patients receiving TREMFYA^® 100 mg subcutaneous injections achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) using observed data at week 56. These data follow initial results that showed 58 percent of patients treated with TREMFYA^® achieved an ACR 20 response at week 24, the primary endpoint of the study, compared with 18.4 percent of patients receiving placebo (p<0.001). Based on the Phase 2 study results, Janssen has initiated two Phase 3 studies to evaluate the efficacy and safety of TREMFYA^® in the treatment of patients with active psoriatic arthritis who may have been previously treated with anti-tumor necrosis factor (TNF) alpha therapies (DISCOVER-1), and in patients who have not received prior treatment with a biologic therapy (DISCOVER-2).

TREMFYA^® received U.S. Food and Drug Administration (FDA) approval in July for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and in September the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization in the European Union for the use of TREMFYA^® in the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

"Patients with active psoriatic arthritis live with substantial disease burden, experiencing joint pain, swelling and stiffness, along with painful skin plaques associated with psoriasis," said Atul Deodhar, M.D., MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University and study steering committee member. "It is encouraging to see that patients receiving this IL-23 inhibitor demonstrated improvement in symptoms of active psoriatic arthritis at week 24, and results were maintained through one year with guselkumab therapy. I look forward to future results from the Phase 3 trials."

The Phase 2 study met all primary and secondary endpoints with statistical significance at week 24. At week 24, patients in the placebo group crossed over to receive TREMFYA^®, and patients originally randomized to active treatment continued TREMFYA^® therapy, both groups receiving every eight-week therapy (after 2 starter doses at weeks 0 and 4) with the final injection administered at week 44.

At week 56, based on the observed data, signs and symptoms of psoriatic arthritis including tender and swollen joints, pain and physical function [measured by the health assessment questionnaire-disability index (HAQ-DI) score], levels of skin clearance (PASI improvements) and patient-reported quality of life outcomes (measured by the SF-36 questionnaire) improved through week 24 and were maintained through week 56 in patients treated with TREMFYA^®. Select efficacy endpoints at week 56 showed:

• ACR 20 and ACR 50 responses were achieved by 74 percent and 53 percent of patients in the TREMFYA^® group, respectively.
• 85 percent of patients in the TREMFYA^® group demonstrated a PASI 75 response.
• 78 percent of patients in the TREMFYA^® group demonstrated a PASI 90 response (near complete skin clearance).
• 57 percent of patients in the TREMFYA^® group demonstrated a PASI 100 response (complete skin clearance).
• Mean improvements in HAQ-DI scores (which range from 0-3.0) were 0.55 for the TREMFYA^® group.
• Patients in the TREMFYA^® group experienced significant improvements in inflammation of the fingers and toes (dactylitis) and sites at which tendons or ligaments attach to bone (enthesitis), as well as measures of physical and mental health as reported by the SF-36 assessment tool.

Post-week 24, there were no observed differences in adverse event (AE) rates among patients with differing lengths of exposure to TREMFYA^®. Through week 56, 40 percent of all patients experienced AEs, the most common of which were infections. Serious AEs were reported in six percent of patients and included one myocardial infarction and one malignancy (basal cell carcinoma). There were no deaths.

"We are proud to have introduced TREMFYA^®, an important new treatment option for patients living with moderate to severe plaque psoriasis," said Newman Yeilding, M.D., Head of Immunology Development, Janssen. "We are also eager to continue the study of TREMFYA^® in the treatment of active psoriatic arthritis through the Phase 3 programs, recognizing that one-third of patients diagnosed with plaque psoriasis will unfortunately develop psoriatic arthritis."

About the Phase 2 TREMFYA^® Psoriatic Arthritis Trial
The Phase 2, randomized, double-blind, placebo-controlled, multicenter trial was designed to evaluate the efficacy and safety of TREMFYA^® compared with placebo in adult patients with active psoriatic arthritis and a body surface area (BSA) of plaque psoriasis greater than or equal to three percent, despite current or previous treatment with standard-of-care therapies, including those previously exposed to anti-tumor necrosis factor (TNF)-alpha agents. Patients (n=149) were randomized in a two-to-one ratio to receive TREMFYA^® 100 mg or placebo by subcutaneous injection at weeks 0, 4 and then every 8 weeks thereafter through week 44. At week 16, patients from either group with less than five percent improvement from baseline in both swollen and tender joint counts were eligible for early escape to open-label ustekinumab. The primary endpoint was the proportion of patients achieving ACR 20 at week 24. At week 24, all remaining placebo patients crossed over to receive TREMFYA^® 100 mg, which was administered again at week 28, and then every 8 weeks thereafter through week 44. The final post-treatment follow-up visit was conducted at week 56.

About TREMFYA^® (guselkumab)
TREMFYA^® is a human monoclonal antibody developed by Janssen that selectively blocks the protein interleukin (IL)-23. TREMFYA^® received U.S FDA approval in July for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In September, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization in the European Union for the use of TREMFYA^® in the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

TREMFYA^® is currently under investigation and is not FDA-approved for active psoriatic arthritis. A Phase 3 program evaluating TREMFYA^® in the treatment of adults with active psoriatic arthritis is ongoing, and a Phase 3 program evaluating the efficacy of TREMFYA^® compared with Cosentyx^®* (secukinumab) in the treatment of adults with moderate to severe plaque psoriasis is underway. A Phase 3 study in moderately to severely active Crohn's disease is also planned.

TREMFYA^® is a registered 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 Psoriatic Arthritis
Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterized by both joint inflammation and the skin lesions associated with psoriasis.¹ It is estimated that one third of the 125 million people living with psoriasis worldwide will also develop psoriatic arthritis.² 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^.1 Though the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.³

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 study and development of TREMFYA^® (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 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 inherent in product research and development, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products or new indications; 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 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. Neither 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.

*Cosentyx^® is a registered trademark of Novartis.

References
1. Mayo Clinic. Psoriatic Arthritis. Available at: http://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/home/ovc-20233896. Accessed October 13, 2017.
2. International Federation of Psoriasis Associations. Our Cause: Psoriasis. Available at: https://ifpa-pso.com/our-cause/. Accessed October 13, 2017.
3. National Psoriasis Foundation. About Psoriatic Arthritis. Available at: http://www.psoriasis.org/psoriatic-arthritis. Accessed October 13, 2017.

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