Janssen Pharmaceutical Release: New Phase III Data Show Anti-TNF Alpha SIMPONI ARIA (golimumab) Significantly Improved Arthritis And Skin Manifestations In Patients With Active Psoriatic Arthritis

MADRID, June 14, 2017 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today results from the pivotal Phase 3 GO-VIBRANT study that showed the significant efficacy of the intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI ARIA^® (golimumab) in the treatment of active psoriatic arthritis. In GO-VIBRANT, 75.1 percent of patients with active psoriatic arthritis receiving SIMPONI ARIA^® 2 mg/kg achieved at least a 20 percent improvement in arthritis signs and symptoms as measured by the American College of Rheumatology (ACR20) at week 14, the study’s primary endpoint, compared with 21.8 percent of patients receiving placebo (P < 0.001). SIMPONI ARIA^® also showed significant improvement across all secondary endpoints evaluating improvements in skin symptoms, joint damage and health-related quality of life measures. Data from GO-VIBRANT are being presented for the first time at the Annual European Congress of Rheumatology (EULAR) 2017. SIMPONI ARIA^® is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis and the treatment of adults with ankylosing spondylitis. SIMPONI ARIA^® is approved in the U.S. for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.

“Results from the GO-VIBRANT study showed that treatment with intravenous golimumab improved joint and skin symptoms in patients with active psoriatic arthritis, and inhibited the progression of structural damage, which are important treatment goals in the management of this progressive, inflammatory disease,” said Arthur Kavanaugh, MD, Professor of Medicine, University of California San Diego, and Chair of the GO-VIBRANT steering committee. “Intravenously administered golimumab could represent an important new anti-TNF-alpha therapy for rheumatologists to consider in the treatment of active psoriatic arthritis in the future.”
Treatment with SIMPONI ARIA^® at weeks 0 and 4 and every eight weeks thereafter resulted in statistically significant improvements in all secondary endpoints presented below (P < 0.001 for all measures).

At week 14

• Among patients receiving SIMPONI ARIA^®, 43.6 percent and 24.5 percent achieved a 50 and 70 percent improvement in signs and symptoms (ACR50 and ACR70), respectively, compared with 6.3 percent and 2.1 percent of patients receiving placebo, respectively.
• A greater proportion of SIMPONI ARIA^®-treated patients achieved a 75 percent improvement in psoriasis as measured by the Psoriasis Area Severity Index (PASI 75) compared with patients receiving placebo (59.2 percent versus 13.6 percent, respectively).
• Mean improvements in the health assessment questionnaire disability index (HAQ-DI) scores were significantly greater for the SIMPONI ARIA^® group compared to the placebo group (0.60 vs 0.12, respectively).
• Change from baseline in the Medical Outcomes Study Short Form-36 questionnaire (SF-36) physical component summary (SF36-PCS) scores and mental component summary (SF36-MCS) scores were significant for the SIMPONI ARIA^® group (8.65 and 5.33, respectively) compared to placebo (2.69 and 0.97, respectively).The SF-36 is a general health assessment that evaluates the physical and mental impact of a disease on quality of life. A clinically meaningful improvement is defined as a 5 point increase or greater.
• Among study participants with enthesitis (inflammation of the entheses, the sites where tendons or ligaments attach to bone), mean change from baseline in enthesitis scores were -1.8 for the SIMPONI ARIA^® group compared to -0.8 for the placebo group.
• Among study participants with dactylitis (inflammation of the entire finger or toe), mean change from baseline in dactylitis scores were -7.8 for the SIMPONI ARIA^® group compared to -2.8 for the placebo group.

At week 24

• Among patients receiving SIMPONI ARIA^®, 53.5 percent achieved ACR50 compared with 6.3 percent of patients receiving placebo.
• Analyses of X-rays at week 24 showed significant inhibition of the progression of structural damage in patients receiving SIMPONI ARIA^® compared with patients receiving placebo, with a mean change from baseline in total modified van der Heijde Sharp scores (vdH-S) of -0.36 vs. 1.95, respectively. The vdH-S score is an X-ray measure of joint destruction and damage, including joint erosion and joint space narrowing, with higher mean change in scores indicating greater structural damage and lower mean change in scores indicating less structural damage.

Through week 24, 46.3 percent of SIMPONI ARIA^®-treated patients and 40.6 percent of placebo-treated patients reported at least one adverse event (AE). Serious AEs were reported by 2.9 percent of patients receiving SIMPONI ARIA^®vs. 3.3 percent for placebo. Two deaths and two malignancies were reported, all in the placebo group, and one demyelinating event occurred in the SIMPONI ARIA^® group. The most common treatment-emergent type of AE was infection, identified in 20.0 percent of SIMPONI ARIA^®-treated patients compared to 13.8 percent of placebo-treated patients. There was no opportunistic infection or tuberculosis through week 24. The rate of infusion reactions with SIMPONI ARIA^® was less than 2 percent and none were serious or severe.

“At Janssen, our commitment to rheumatology began more than two decades ago with discovery, development and approval of the first anti-TNF-alpha therapy, and since then, we have continued to build upon our portfolio of medicines for patients with immune-mediated diseases,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “Data from the GO-VIBRANT study demonstrated how SIMPONI ARIA^®, a product already helping people living with moderately to severely active rheumatoid arthritis, may also help those living with psoriatic arthritis, pending its approval in the U.S.”

Additional SIMPONI ARIA^® data being presented at EULAR 2017 includes findings from the Phase 3 ankylosing spondylitis GO-ALIVE study:

• Improvements in Sleep Problems and Pain in Patients with Active Ankylosing Spondylitis Treated with Intravenous Golimumab: 28-Week Results
• Safety and Efficacy of Intravenous Golimumab in Adult Patients with Active Ankylosing Spondylitis: Results through Week 28

About GO-VIBRANT
The GO-VIBRANT trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of intravenous (IV) golimumab (SIMPONI ARIA^®) in biologic-naïve adult patients with active psoriatic arthritis. Patients (n=480) were randomized one-to-one to receive SIMPONI ARIA^® 2 mg/kg at weeks 0, 4, and every 8 weeks thereafter or placebo at weeks 0, 4, 12, and 20 with crossover to SIMPONI ARIA^® at week 24. The primary endpoint was ACR20 response at week 14. Multiplicity-controlled endpoints at week 14 included ACR50, ACR70, PASI 75, change from baseline in HAQ-DI, enthesitis, dactylitis, and SF-36 PCS/MCS scores. At week 24, ACR50 and change from baseline in total modified vdH-S (structural damage) score were evaluated.

About GO-ALIVE
GO-ALIVE is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of IV golimumab (SIMPONI ARIA^®) in adult patients with active ankylosing spondylitis. Patients had a diagnosis of definite ankylosing spondylitis per modified New York criteria, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) greater than or equal to four, total back pain visual analogue scale greater than or equal to four, and C-reactive protein greater than or equal to 0.3 mg/dL. Up to 20 percent of patients could have had prior anti-TNF-alpha treatment with agents other than subcutaneous SIMPONI^® (golimumab) and up to 10 percent of patients could have complete ankylosis of the spine. Patients (n=208) were randomized one-to-one to receive SIMPONI ARIA^® 2 mg/kg at weeks 0, 4, and every 8 weeks or placebo at week 0, 4, and 12, with crossover to SIMPONI ARIA^® at week 16. The study continued through 60 weeks.

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.³ 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 Ankylosing Spondylitis
Ankylosing spondylitis is a chronic, immune-mediated disease of the axial skeleton, affecting the sacroiliac joints and the spine. Ankylosing spondylitis frequently also causes enthesitis, or inflammation where ligaments and muscles attach to bones, most commonly those within the spine. It is the primary disease in a group of arthritis-related diseases known as spondylitis, spondyloarthropathy or spondyloarthritis.⁴ Peripheral joint involvement (in particular, hips and shoulders) can occur. Other organs can also be involved including eyes (uveitis), heart and aorta, and lungs. The disease affects men more often than women and typically manifests in early adulthood.⁵ In contrast to mechanical low back pain, low back pain and stiffness with ankylosing spondylitis worsen after a period of rest or upon waking up in the morning and improve after exercise, a hot bath or a shower.⁵

About SIMPONI ARIA^® (golimumab) infusion
SIMPONI ARIA^® is an infusible, fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. By binding with and blocking TNF-alpha, SIMPONI ARIA^® helps control inflammation. SIMPONI ARIA^® is approved in 23 countries, including the U.S., as a 30-minute infusion for the treatment of adult patients with moderately to severely active RA with the medicine methotrexate.

More information about SIMPONI ARIA^® is available at www.SimponiARIA.com.

Janssen Biotech, Inc. discovered and developed SIMPONI ARIA^®.

Important Safety Information

SERIOUS INFECTIONS
SIMPONI ARIA^® (golimumab) is a prescription medicine. SIMPONI ARIA^® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI ARIA^® and will closely monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not receive SIMPONI ARIA^® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:

• fever, sweats, or chills
• muscle aches
• cough
• shortness of breath
• blood in phlegm
• weight loss
• warm, red, or painful skin or sores on your body
• diarrhea or stomach pain
• burning when you urinate or urinate more than normal
• feel very tired

CANCER
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults receiving TNF blockers, including SIMPONI ARIA^®, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking a TNF blocker with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.

Some people treated with SIMPONI ARIA^® developed skin cancer. Tell your doctor if any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI ARIA^®. Your doctor should periodically examine your skin, especially if you have a history of skin cancer.

USE WITH OTHER DRUGS
Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), RITUXAN (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People receiving SIMPONI ARIA^® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).

HEPATITIS B INFECTION
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are receiving TNF-blocker medicines, such as SIMPONI ARIA^®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI ARIA^®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:

• feel very tired
• clay-colored bowel movements
• dark urine
• fevers
• skin or eyes look yellow
• little or no appetite
• vomiting
• muscle aches
• chills
• stomach discomfort
• skin rash

HEART FAILURE
Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI ARIA^®. If you develop new or worsening heart failure with SIMPONI ARIA^®, you may need treatment in a hospital, and it may result in death. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath, swelling of your lower legs or feet, or sudden weight gain.

NERVOUS SYSTEM PROBLEMS
Rarely, people using TNF blockers, including SIMPONI ARIA^®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.

IMMUNE SYSTEM PROBLEMS
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles or legs.

LIVER PROBLEMS
Serious liver problems can happen in people using TNF blockers, including SIMPONI ARIA^®. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

BLOOD PROBLEMS
Low blood counts have been seen with people using TNF blockers, including SIMPONI ARIA^®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

ALLERGIC REACTIONS
Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI ARIA^®. Tell your doctor if you have any symptoms of an allergic reaction while receiving SIMPONI ARIA^® such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.

OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you have psoriasis.

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and received SIMPONI ARIA^® during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.

COMMON SIDE EFFECTS
The most common side effects of SIMPONI ARIA^® include: upper respiratory infection, viral infections, bronchitis, high blood pressure, and rash.

Please read the full Prescribing Information and Medication Guide for SIMPONI ARIA^® 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.

042590-151029

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 development, potential benefits and expanded indications of SIMPONI ARIA^®. 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/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 or financial distress 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 under the caption “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.

References

¹ Mayo Clinic. Psoriatic Arthritis. Available at: http://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/home/ovc-20233896. Accessed May 8, 2017.
² International Federation of Psoriasis Associations. Our Cause: Psoriasis. Available at: https://ifpa-pso.com/our-cause/. Accessed May 8, 2017.
³National Psoriasis Foundation. About Psoriatic Arthritis. Available at: http://www.psoriasis.org/psoriatic-arthritis. Accessed May 8, 2017.
⁴Arthritis Foundation. Ankylosing Spondylitis. Available at http://www.arthritis.org/about-arthritis/types/ankylosing-spondylitis. Accessed May 15, 2017.
⁵Mayo Clinic. Ankylosing Spondylitis. Available at http://www.mayoclinic.org/diseases-conditions/ankylosing-spondylitis/home/ovc-20261048. Accessed May 15, 2017.

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