New Phase 3 Data Show SIMPONI® Intravenous Formulation Significantly Improved Rheumatoid Arthritis Signs And Symptoms In Patients With Active Disease

BERLIN, June 5, 2012 /PRNewswire/ -- Phase 3 study findings presented today showed that patients with active moderate to severe rheumatoid arthritis (RA) who received an investigational intravenous (I.V.) formulation of the anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI^® (golimumab) [hereafter referred to as SIMPONI I.V.] demonstrated significant improvements in signs and symptoms and disease activity.  Investigators reported nearly 60 percent of patients receiving SIMPONI I.V. achieved a 20 percent improvement in arthritis signs and symptoms at week 14, the study's primary endpoint, and more than 80 percent of patients demonstrated meaningful improvements in disease activity as assessed by European League Against Rheumatism (EULAR) criteria at week 14.  Results from the Janssen Research & Development, LLC, (Janssen)-sponsored study were presented at the 2012 EULAR Annual Congress and the study appears in the June 1, 2012 Online First feature in Annals of the Rheumatic Diseases.

"The data show the significant benefits of SIMPONI in improving the pain, stiffness and swelling associated with rheumatoid arthritis when administered intravenously," said Rene Westhovens, M.D., Ph.D., Professor at the Department of Rheumatology, KU Leuven, Belgium, and study investigator.  "Marked improvements were seen at week 14 and increased through week 24 in patients receiving SIMPONI I.V. induction and maintenance therapy."

In the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER) trial, patients with active RA despite treatment with methotrexate were randomized 2:1 to receive a 30 (+/- 10) minute infusion of SIMPONI I.V. 2 mg/kg (n=395) or placebo (n=197) plus methotrexate at weeks 0, 4 and then every 8 weeks.  At week 14, 59 percent of patients receiving SIMPONI I.V. achieved at least a 20 percent improvement in signs and symptoms according to American College of Rheumatology (ACR) criteria (ACR 20) and 30 percent achieved at least a 50 percent improvement in ACR criteria (ACR 50) compared with 25 and 9 percent of patients receiving placebo, respectively (P < 0.001).  Significant improvements in ACR 20 and ACR 50 were observed at week 2, after a single SIMPONI I.V. infusion as 33 percent of patients achieved an ACR 20 response versus 12 percent of patients receiving placebo (P < 0.001), and 6 percent of patients achieved an ACR 50 response versus 3 percent of patients receiving placebo, respectively.  At week 24, 63 percent of patients receiving SIMPONI I.V. achieved an ACR 20 response versus 32 percent of patients receiving placebo, and 35 percent of patients receiving SIMPONI I.V. achieved an ACR 50 response versus 13 percent of patients receiving placebo (P < 0.001 for both comparisons).

Patients in the SIMPONI I.V. group also reported statistically significant improvements in EULAR/Disease Activity Score (DAS) 28 C-reactive protein (CRP) moderate or good responses.  At week 14, 81 percent of patients receiving SIMPONI I.V. achieved moderate or good EULAR/DAS 28 CRP response compared with 40 percent of patients receiving placebo (P < 0.001).  Significant improvements also were observed at week 2 after a single SIMPONI I.V. infusion as 65 percent of patients achieved moderate or good EULAR/DAS 28 CRP response compared with 19 percent of patients receiving placebo (P < 0.001).  The EULAR/DAS 28 is a measure of disease activity in patients with RA that is calculated by assessing the number of tender and swollen joints (among a total of 28), inflammation and the patient's assessment of global health.  CRP is a type of protein produced in the liver and is expressed during episodes of acute inflammation associated with RA.

Patients receiving SIMPONI I.V. also achieved clinically relevant improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ) [improvement in HAQ greater than 0.25 from baseline], as compared with the placebo group at week 14 (68 percent vs. 43 percent, P < 0.001) and week 24 (68 percent vs. 45 percent, P < 0.001). HAQ assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living). 

Adverse events (AEs) were reported in 47 percent of patients receiving SIMPONI I.V. and 44 percent of patients receiving placebo at week 16, and in 53 percent of patients receiving SIMPONI I.V. and 49 percent of patients receiving placebo at week 24.  Serious AEs were reported in more SIMPONI I.V.-treated patients (4 percent) than placebo-treated patients (2 percent) through week 24.  The most common serious AEs were serious infections, 1 percent in the SIMPONI I.V. group versus 0 percent in the placebo group.  No cases of tuberculosis, serious opportunistic infections, congestive heart failure or demyelination were reported.  Through week 24, the proportion of infusions with infusion reactions in the SIMPONI I.V. versus placebo groups were 1.1 percent versus 0.2 percent, respectively, (3.5 percent and 0.5 percent of patients, respectively) with a median infusion time of 30 minutes.  There were no serious infusion reactions.  One malignancy (breast cancer) was reported in the SIMPONI I.V. group through week 24, and one patient in the placebo group died of a presumed stroke.

Results of SIMPONI I.V. on Rheumatoid Arthritis Associated Fatigue
A second abstract presented at the meeting evaluated the association of fatigue with physical function and disease activity in patients with RA, and the impact of treatment with SIMPONI I.V. on fatigue based on data from the GO-FURTHER trial.  Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire, investigators found that patients enrolled in the GO-FURTHER trial experienced significant fatigue at baseline with a FACIT-Fatigue score of 25.5 (scores range from 0-52 with high scores representing less fatigue).  A significantly greater proportion of patients receiving SIMPONI I.V. (58 percent) achieved clinically meaningful improvement in fatigue at week 12 compared with patients receiving placebo (43 percent), and improvements at week 24 of the study were reported in 66 percent of SIMPONI I.V.-treated patients compared with 40 percent of patients receiving placebo (P < 0.001).  The FACIT-Fatigue questionnaire assesses patient-reported physical, social/family, emotional and functional well-being for those living with a chronic illness to evaluate disease-related fatigue.  Clinically meaningful improvement in fatigue was defined as at least a four point increase in FACIT-Fatigue scores.

"Severe fatigue is common in patients with rheumatoid arthritis," said Professor Westhovens.  "This analysis of the GO-FURTHER study showed patients who are inadequately responsive to methotrexate and treated with SIMPONI I.V. reported significant improvements in clinical symptoms of fatigue."

About GO-FURTHER
The GO-FURTHER trial is a Phase 3, international multicenter, double-blind, placebo-controlled study including 592 adults with rheumatoid arthritis (RA) designed to compare American College of Rheumatology (ACR 20) response at week 14 in patients receiving an intravenous (I.V.) formulation of SIMPONI plus methotrexate compared with patients receiving placebo plus methotrexate. The trial included patients diagnosed with active RA who had at least six tender and six swollen joints and who had been receiving background methotrexate for at least three months. Patients were randomized to two groups: SIMPONI I.V. 2 mg/kg plus methotrexate at weeks 0, 4, and then every eight weeks or placebo plus methotrexate.  Patients received a 30 (+/- 10) minute I.V. infusion.  At week 16, patients receiving placebo with less than 10 percent improvement in combined swollen and tender joint counts were entered into early escape to receive SIMPONI I.V. 2 mg/kg at week 16 and week 20.  All patients receiving placebo crossed over to SIMPONI I.V. at week 24.

About Rheumatoid Arthritis
Rheumatoid Arthritis is a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability.  It is estimated that 1.5 million Americans[1] and more than 23.5 million people worldwide[2] are affected by the condition, for which there is no cure.

About SIMPONI^® (golimumab)
SIMPONI is a human monoclonal antibody that targets and neutralizes excess 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.  SIMPONI is approved in 52 countries for rheumatologic indications, including the United States where SIMPONI received FDA approval in April 2009 for the treatment of moderately to severely active RA with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate and active ankylosing spondylitis and is available either through the SmartJect^® autoinjector or a prefilled syringe as a once-monthly subcutaneously administered injection.  For more information about SIMPONI, visit www.SIMPONI.com.  

In addition to a Phase 3 study investigating an I.V. formulation of SIMPONI for the treatment of moderately to severely active RA, SIMPONI is also being investigated in Phase 3 studies as a subcutaneously administered treatment for moderately to severely active ulcerative colitis and active polyarticular juvenile idiopathic arthritis (JIA).

Janssen Biotech, Inc. discovered and developed SIMPONI and markets the product in the United States.  Janssen pharmaceutical companies market SIMPONI in Canada, Central and South America, the Middle East, Africa and Asia Pacific. 

In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries.  In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. 

The U.S. full prescribing information for SIMPONI^® can be accessed at the following link:  http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf

For further information about SIMPONI outside of the United States, please consult the relevant official product information applicable to that country location.

Important Safety Information 
SIMPONI^® (golimumab) is a prescription medicine. SIMPONI^® 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^® and will 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 start SIMPONI^® 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, sweat, 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

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI^®, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.

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 taking SIMPONI^® should not receive live vaccines.

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI^®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI^®. 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
• dark urine
• skin or eyes look yellow
• little or no appetite
• vomiting
• muscle aches
• clay-colored bowel movements
• fevers
• chills
• stomach discomfort
• skin rash

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI^®. 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 or swelling of your lower legs or feet. 

Rarely, people using TNF blockers, including SIMPONI^®, can have nervous system problems such as multiple sclerosis or Guillain-Barre 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.  

Serious liver problems can happen in people using TNF blockers, including SIMPONI^®. 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.

Low blood counts have been seen with people using TNF blockers, including SIMPONI^®. 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.

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, and/or legs.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.  

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI^® 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.

Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.

Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI^® such as hives, swollen face, breathing trouble, chest pain. Some reactions can be serious and life-threatening.

Common side effects of SIMPONI^® include: upper respiratory tract infection, reaction at site of injection, and viral infections. 

Please read the Medication Guide for SIMPONI^® 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.

The U.S. full prescribing information for SIMPONI^® can be accessed at the following link:  http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf

About Janssen Research & Development, LLC

At Janssen Research & Development, LLC, we are united and energized by one mission—to discover and develop innovative medicines that ease patients' suffering, and solve the most important unmet medical needs of our time.  As one of the Janssen Pharmaceutical Companies of Johnson & Johnson, our strategy is to identify the biggest unmet medical needs and match them with the best science, internal or external, to find solutions for patients worldwide. We leverage our world-class discovery and development expertise, and operational excellence, to bring innovative, effective treatments in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  For more information on Janssen R&D, visit http://www.janssenrnd.com/.

[1] Centers for Disease Control and Prevention. Arthritis-Related Statistics.  Available at: http://www.cdc.gov/arthritis/data_statistics/arthritis_related_stats.htm.  Accessed April 17, 2012.

[2] World Health Organization. The global burden of disease: 2004 update. Geneva: WHO Press, 2008.  Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.  Accessed April 17, 2012.

SOURCE Janssen Research & Development, LLC

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