TREMFYA® (guselkumab) Study Indicating The Significance Of Inhibiting IL-23 Pathway In Adults With Psoriatic Arthritis Published In The Lancet

SPRING HOUSE, Pa., June 4, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced results from a Phase 2 study that were published in The Lancet demonstrating positive results for TREMFYA^® (guselkumab), the first selective anti-interleukin (IL)-23 monoclonal antibody under investigation for the treatment of adults with active psoriatic arthritis. According to the findings, 58 percent of patients receiving TREMFYA achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) at week 24, the primary endpoint of the study, compared with 18.4 percent of patients receiving placebo (p<0.001). Similar results were observed for the primary and other key endpoints at one year.

"We know that adults living with psoriatic arthritis experience significant physical impact despite the availability of therapies," said Atul Deodhar, M.D., MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University and study steering committee member. "The findings published today demonstrate the promise of guselkumab, which is already proven to achieve high levels of skin clearance in psoriasis, in addressing the pain and functional disability associated with active psoriatic arthritis. This supports the growing body of evidence indicating that IL-23 may be a critical target for the treatment of psoriatic arthritis, and we look forward to seeing further results from the Phase 3 program."

In the Phase 2 study, patients received subcutaneous TREMFYA 100 mg or placebo at weeks 0, week 4 and every 8 weeks thereafter. The study met all primary and secondary endpoints at week 24, with some patients achieving rapid, statistically significant improvement in joint and skin disease as early as week 4. At week 24, 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], as well as levels of skin clearance (PASI improvements), improved in patients treated with TREMFYA compared with placebo:

• ACR 20 and ACR 50 responses were achieved by 58 percent and 34 percent of patients in the TREMFYA group, respectively. In the placebo group, ACR 20 and ACR 50 responses were achieved by 18 percent (p=<0.0001) and 10 percent (p=0.0021), respectively.
• Mean improvement in HAQ-DI scores (which range from 0-3.0) was 0.42 for the TREMFYA group vs. 0.06 for placebo (p=0.0002).
• 66 percent of patients in the TREMFYA group demonstrated near complete skin clearance (PASI 90 response) compared with 6 percent of patients in the placebo group (p=<0.0001).
• 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). Of patients with dactylitis at baseline, 55 percent in the TREMFYA group had complete resolution of dactylitis compared with 17 percent receiving placebo (p=0.0014). Of patients with enthesitis at baseline, 57 percent in the TREMFYA group had complete resolution of enthesitis compared with 29 percent receiving placebo (p=0.0124).

Furthermore, a significant percentage of patients receiving TREMFYA (23 percent) achieved Minimal Disease Activity (MDA) compared with those receiving placebo (2 percent, p=0.001) through the first 24 weeks of the study, and patients in the TREMFYA group experienced significant improvements in measures of physical and mental health as reported by the SF-36 assessment tool. Results were maintained through week 56 of the study.

During the first 24 weeks of the study, 36 percent of patients receiving TREMFYA experienced adverse event (AE) rates compared with 33 percent of patients receiving placebo. Through week 56, 40 percent of patients receiving TREMFYA experienced AEs, the most common of which were infections. The rates of AEs were similar between treatment groups. Two serious AEs were reported within the first 24 weeks of the study: one patient in the placebo group had joint injury and one patient in the TREMFYA group had myocardial infarction. Through week 56, five additional serious AEs were reported by patients who had received TREMFYA, and one patient had malignancy (basal cell carcinoma). There was no trend for increasing rates of AEs with increasing duration of treatment with TREMFYA in patients through one year of the study.

"Recognizing the profound physical impact of psoriatic arthritis and the need for more targeted therapies to treat this disease, we are excited to continue the study of guselkumab in Phase 3 trials," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC.  "These data indicate that guselkumab may offer dermatologists and rheumatologists a potential new option to achieve significant improvements in joint disease in the one in three patients¹ with psoriasis who experience psoriatic arthritis."

Based on the Phase 2 study results, two Phase 3 studies are actively recruiting patients to evaluate the efficacy and safety of TREMFYA in the treatment of patients with active psoriatic arthritis, including those 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 approval in July 2017 for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy from the U.S. Food and Drug Administration (FDA). Subsequent approvals for psoriasis followed in November 2017 in Canada and the European Union.

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 TREMFYA100 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 as a prescription medicine in July 2017 for the treatment of adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light or UV light). In November 2017, TREMFYA was also approved in Canada, the European Union, and several other countries worldwide for the treatment of adults with moderate to severe plaque psoriasis.

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 study evaluating the efficacy of TREMFYA compared with Cosentyx^®* (secukinumab) in the treatment of adults with moderate to severe plaque psoriasis is underway. A Phase 2b/3 study in moderately to severely active Crohn's disease is also ongoing.

TREMFYA is a registered trademark of Janssen Biotech, Inc.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TREMFYA (guselkumab)?

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
• diarrhea or stomach pain
• muscle aches
• shortness of breath
• weight loss
• blood in your phlegm (mucus)
• cough
• burning when you urinate or urinating more often than normal
• warm, red, or painful skin or sores on your body different from your psoriasis

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.

About Psoriatic Arthritis
Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterized by both joint inflammation and the skin lesions associated with psoriasis.² It is estimated that one third of the 125 million people living with psoriasis worldwide will also develop psoriatic arthritis.¹ 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.² 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 of Johnson & Johnson
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. 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 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 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 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's subsequent Quarterly Reports on Form 10-Q and other 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. International Federation of Psoriasis Associations. Our Cause: Psoriasis. Available at: https://ifpa-pso.com/our-cause/. Accessed May 18, 2018.
2. Mayo Clinic. Psoriatic Arthritis. Available at: http://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/home/ovc-20233896. Accessed May 18, 2018.
3. National Psoriasis Foundation. About Psoriatic Arthritis. Available at: http://www.psoriasis.org/psoriatic-arthritis. Accessed May 18, 2018.

SOURCE Janssen Pharmaceutical Companies

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