New Results From Second Phase 3 Study Show Significant Efficacy Of Guselkumab And Superiority Versus Humira® In Treatment Of Moderate To Severe Plaque Psoriasis

ORLANDO, Fla., March 3, 2017 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today new findings from two pivotal Phase 3 studies reporting the efficacy and safety of guselkumab in the treatment of adults with moderate to severe plaque psoriasis. Data from the VOYAGE 2 study showed that patients treated with guselkumab experienced significant improvements in skin clearance and other measures of disease activity compared with placebo, and significantly greater improvements compared with the anti-tumor necrosis factor (TNF)-alpha treatment Humira^® (adalimumab). VOYAGE 2 is the second Phase 3 study to demonstrate superior efficacy of guselkumab versus adalimumab following VOYAGE 1. Data from a third Phase 3 study (NAVIGATE) showed that patients who had an inadequate response following treatment with the anti-interleukin (IL)-12/23 monoclonal antibody (mAb) STELARA^® (ustekinumab) and who then switched to guselkumab, showed significantly greater improvements in skin clearance compared with patients who continued to receive STELARA^®. These Phase 3 data are being presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in Orlando, FL, March 3-7. Guselkumab, a subcutaneously administered anti-IL-23 mAb is currently under review by health authorities in the U.S. and Europe for the treatment of adults living with moderate to severe plaque psoriasis.

VOYAGE 2: Efficacy and safety of guselkumab compared with adalimumab for the treatment of moderate to severe plaque psoriasis
In the VOYAGE 2 study, the co-primary endpoints were met at week 16, with 84.1 percent of patients receiving guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks achieving an Investigator's Global Assessment (IGA) score of cleared (0) or minimal (1) disease compared with 8.5 percent of patients receiving placebo (P < 0.001). In addition, 70.0 percent of patients receiving guselkumab achieved a Psoriasis Area Severity Index (PASI) 90 score (near complete skin clearance) compared with 2.4 percent of patients receiving placebo (P < 0.001).

Major secondary endpoints in VOYAGE 2 achieved statistical significance in comparisons of guselkumab versus adalimumab administered subcutaneously at weeks 0 (80 mg), 1 (40 mg) and then 40 mg every other week (all P < 0.001). At week 16, following three injections of guselkumab and ten injections of adalimumab, significantly higher proportions of patients receiving guselkumab versus adalimumab achieved IGA 0/1 (84.1 percent versus 67.7 percent, respectively) and PASI 90 (70.0 percent versus 46.8 percent, respectively). Guselkumab continued to demonstrate superiority versus adalimumab at week 24 for both the IGA 0/1 and PASI 90 scores. Among other secondary endpoints, significantly higher proportions of patients receiving guselkumab compared with adalimumab achieved Dermatology Life Quality Index (DLQI) scores of 0/1 (indicating no impact of psoriasis on health-related quality of life) and PASI 100 scores (complete skin clearance) at week 24. Additionally, at week 16 and 24, 34.1 percent and 44.2 percent of patients receiving guselkumab achieved PASI 100 responses, respectively.

"The majority of patients treated with guselkumab achieved high levels of skin improvement (more than 80 percent IGA 0/1 and nearly 70 percent PASI 90) at week 16, while this was rarely seen in patients receiving placebo (less than 10 percent); a difference that was highly significant.  Higher rates in efficacy in major secondary endpoints comparing guselkumab with adalimumab were also demonstrated and significant," said Kristian Reich, Ph.D., M.D., Dermatologikum Hamburg, VOYAGE 2 study investigator. "These findings are consistent with the previously presented Phase 3 VOYAGE 1 study results and further demonstrate the important role of selectively targeting IL-23 in an immune-mediated disease like plaque psoriasis."

Through week 16, the placebo-controlled period, 44.8 percent, 47.6 percent and 48.4 percent of patients receiving placebo, guselkumab and adalimumab, respectively, reported at least one adverse event (AE). Serious AEs were reported in 1.2 percent of patients receiving placebo, 1.6 percent of patients receiving guselkumab and 2.4 percent of patients receiving adalimumab. Serious infections occurred in one patient receiving placebo, one patient receiving guselkumab and two patients receiving adalimumab. During this period, no malignancies were reported, and one major adverse cardiovascular event (MACE) was reported (in the adalimumab group).

Through week 28, the active comparator period, patients receiving guselkumab (58.3 percent) and adalimumab (62.9 percent) reported at least one AE. Serious AEs were reported in 3.6 percent of patients receiving guselkumab and 3.6 percent of patients receiving adalimumab. Infections and infections requiring treatment were also comparable between guselkumab and adalimumab groups. Three serious infections each were reported in the guselkumab (bronchitis, erysipelas and soft-tissue infection) and adalimumab (2 cases of tuberculosis [1 disseminated] and 1 injection-site abscess) groups. One malignancy of prostate cancer in the guselkumab group and 2 non-melanoma skin cancers (1 squamous cell carcinoma in the guselkumab group and 1 basal cell carcinoma in the placebo to guselkumab group) were reported. Two major adverse cardiovascular events (MACE) were reported (1 myocardial infarction each in the guselkumab and adalimumab groups). There were no deaths.

NAVIGATE: Efficacy and safety of switching to guselkumab in moderate to severe plaque psoriasis patients with an inadequate response to STELARA^®
The NAVIGATE study evaluated the efficacy and safety of guselkumab in patients who continued to experience mild to severe skin symptoms (IGA of 2 or more) following 16 weeks of treatment with STELARA^®. Patients who switched to guselkumab consistently showed greater improvement in their psoriasis between weeks 28 and 40, compared with patients who continued to receive STELARA^®, having twice as many office visits with at least a 2 point improvement in IGA from week 16, the study's primary endpoint, and an IGA score of 0 or 1 (1.5 and 0.7 respectively; P < 0.001). Guselkumab also demonstrated superiority across major secondary endpoints in comparisons with STELARA^®. Major secondary endpoints included the number of visits that patients achieved a PASI 90 response or IGA score of 0 between weeks 28 and 40, and the proportions of patients that achieved an IGA score of 0 or 1 with at least a 2 point improvement from week 16 at week 28 (all P ≤ 0.001). In addition, a significantly higher proportion of patients in the guselkumab group achieved an IGA score of 0 or 1 and at least a 2 point improvement from week 16 at week 52, and a PASI 90 response at weeks 28 and 52, compared with STELARA^® (all P < 0.001).

"Findings from NAVIGATE showed treatment with guselkumab provided significant benefit to patients who were not achieving clear or almost clear skin with STELARA^® treatment," said Richard Langley, M.D., FRCPC, Professor, Division of Clinical Dermatology & Cutaneous Science, Department of Medicine, Dalhousie University, NAVIGATE study investigator. "These data show the effectiveness of guselkumab in patients who had an inadequate response to treatment with STELARA^® and provide further insights into the therapeutic profile of guselkumab in this patient population."

Through week 60, AEs were reported in 64.4 percent of patients receiving guselkumab and 55.6 percent of patients receiving STELARA^®. Serious AEs were reported in 6.7 percent of patients receiving guselkumab and 4.5 percent in patients treated with STELARA^®, including 3 myocardial infarctions (2 from the guselkumab-treated group and 1 from the ustekinumab-treated group) and 2 malignancies (bladder carcinoma and a fatal squamous cell carcinoma of the neck, both in the guselkumab-treated group). A serious infection occurred in 1 patient receiving guselkumab.

Results through week 48 for both the ongoing VOYAGE 1 and VOYAGE 2 studies were recently published in the Journal of the American Academy of Dermatology. Together with NAVIGATE, these three Phase 3 studies comprise the comprehensive clinical development program evaluating guselkumab in the treatment of moderate to severe plaque psoriasis.

"At Janssen, we are committed to building upon our understanding of psoriasis and bringing forward innovative therapies that continue to meet the needs of people living with immune-mediated diseases like psoriasis," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "Data from the Phase 3 VOYAGE 2 and NAVIGATE studies continue to demonstrate the potential that guselkumab may offer patients and physicians, and we are committed to working with health authorities around the world on our current and future applications."

About VOYAGE 2
The Phase 3 VOYAGE 2 trial is a randomized, double-blind, placebo- and active-comparator controlled study with randomized withdrawal and retreatment from weeks 28 to 76, data that will be presented in the future. The trial is designed to evaluate the safety and efficacy of guselkumab compared with placebo and adalimumab and of guselkumab 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 guselkumab 100 mg at weeks 0, 4, 12 and 20; placebo at weeks 0, 4, and 12 with crossover to guselkumab 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.

About NAVIGATE
The Phase 3 NAVIGATE trial was a randomized, double-blind, multicenter study evaluating the efficacy and safety of guselkumab compared with STELARA^® in adult patients with moderate to severe plaque psoriasis who had an inadequate response to treatment with STELARA^®. Patients (n=871) received SC injections of STELARA^® 45 mg or 90 mg (based on weight) at weeks 0 and 4 during open-label treatment. At week 16, patients (n=268) with an IGA score greater than or equal to 2 were considered inadequate responders and were randomized to receive guselkumab 100 mg at weeks 16 and 20 and then every eight weeks through week 44, or to continue on STELARA^® every 12 weeks through week 40; patients (n=585) who achieved an IGA score of 0/1 at week 16 continued to receive STELARA^® every 12 weeks through week 40. Safety results were monitored through week 60.

About Guselkumab
Guselkumab is a human monoclonal antibody with a novel mechanism of action that specifically targets the protein interleukin (IL)-23 and is currently under review by health authorities in the U.S. and in Europe as a subcutaneously administered therapy for the treatment of adults living with moderate to severe plaque psoriasis. Results of a Phase 2 study evaluating guselkumab in the treatment of patients with active psoriatic arthritis were presented for the first time at the 2016 ACR/ARHP Annual Meeting and will be presented at the AAD Annual Meeting. A Phase 3 program evaluating the efficacy and safety of guselkumab for the treatment of active psoriatic arthritis is planned.

About STELARA^® (ustekinumab)
STELARA^® is a human interleukin (IL)-12 and IL-23 antagonist indicated in the U.S. for the treatment of adult patients with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis, alone or in combination with methotrexate; and moderately to severely active Crohn's disease who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA^®, which is currently approved for the treatment of moderate to severe plaque psoriasis in 89 countries, active psoriatic arthritis in 79 countries, pediatric psoriasis in 33 countries and moderately to severely active Crohn's disease in 32 countries.

IMPORTANT SAFETY INFORMATION
STELARA^® is a prescription medicine that affects your immune system. STELARA^® can increase your chance of having serious side effects including:

Serious Infections
STELARA^® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA^®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

• Your doctor should check you for TB before starting STELARA^® and watch you closely for signs and symptoms of TB during treatment with STELARA^®.
• If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA^®.

You should not start taking STELARA^® if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA^®, tell your doctor if you:

• think you have an infection or have symptoms of an infection such as:
  • fever, sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in your phlegm
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feel very tired
• are being treated for an infection
• get a lot of infections or have infections that keep coming back
• have TB, or have been in close contact with someone who has TB

After starting STELARA^®, call your doctor right away if you have any symptoms of an infection (see above).

STELARA^® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and interleukin 23 (IL‐23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA^® may also be more likely to get these infections.

Cancers
STELARA^® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA^®. Tell your doctor if you have any new skin growths.

Reversible posterior leukoencephalopathy syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions
Serious allergic reactions can occur. Stop using STELARA^® and get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Before receiving STELARA^®, tell your doctor if you:

• have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS.
• ever had an allergic reaction to STELARA^® or any of its ingredients. Ask your doctor if you are not sure.
• are allergic to latex. The needle cover on the prefilled syringe contains latex.
• have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA^® should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking STELARA^® or one year after you stop taking STELARA^®.
• have any new or changing lesions within psoriasis areas or on normal skin.
• are receiving or have received allergy shots, especially for serious allergic reactions.
• receive or have received phototherapy for your psoriasis.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if STELARA^® will harm your unborn baby. You and your doctor should decide if you will take STELARA^®.
• are breast‐feeding or plan to breast‐feed. It is thought that STELARA^® passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take STELARA^®.

Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

When prescribed STELARA^®:

• Use STELARA^® exactly as prescribed by your doctor.
• If your doctor decides that you or a caregiver may give your injections of STELARA^® at home, you should receive training on the right way to prepare and inject STELARA^®. Do not try to inject STELARA^® yourself until you or your caregiver has been shown how to inject STELARA^® by your doctor or nurse.

Common side effects of STELARA^® include: upper respiratory infections, headache, and tiredness in psoriasis patients; joint pain and nausea in psoriatic arthritis patients; and upper respiratory infections, redness at the injection site, vaginal yeast infections, itching, urinary tract infections, and vomiting in Crohn's disease patients. These are not all of the possible side effects with STELARA^®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

Please read the full Prescribing Information and Medication Guide for STELARA^® and discuss any questions 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 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. 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.^1-4

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 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 potential benefits, and plans for continued development, of 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 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 3, 2016, including in Exhibit 99 thereto, 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 Janssen Research & Development, LLC nor 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. Psoriasis Fact Sheet. https://www.psoriasis.org/sites/default/files/psoriasis_fact_sheet.pdf. Accessed January 24, 2017.
2. National Psoriasis Foundation. Advocacy Toolkit. https://www.psoriasis.org/toolkit/the-burden-of-psoriatic-diseases. Accessed February 22, 2017.
3. Parisi R, et al. Global Epidemiology of Psoriasis: A Systematic Review. J Invest Dermatol. 2013;133:377-385.
4. The Dermatologist. World Psoriasis Day 2013 Puts A Face on the Skin Disease.
   http://www.the-dermatologist.com/node/2825. Accessed January 24, 2017.

SOURCE Janssen Research & Development, LLC

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