MADRID, Spain, 12 June 2013 – Janssen Biotech, Inc. announced today new five-year data from three pivotal Phase 3 studies evaluating SIMPONI® (golimumab) 50 mg administered subcutaneously once every four weeks in the treatment of moderately to severely active rheumatoid arthritis (RA). The new findings from open-label, long-term extensions of the pivotal registration trials are results from the use of SIMPONI in several RA populations. The populations studied included patients naïve to methotrexate, patients with active disease despite methotrexate (MTX) and patients who had previously received anti-tumor necrosis factor (anti-TNF) agents. Among patients continuing treatment with SIMPONI 50 mg in combination with methotrexate or other disease-modifying antirheumatic drugs (DMARDs) through five years, between 60 and 85 percent of patients experienced at least a 20 percent improvement in American College of Rheumatology criteria (ACR 20) at the end of the treatment period. The findings are being presented at the 2013 European League Against Rheumatism (EULAR) Annual Congress.
“These five-year data are important and provide rheumatologists insights into how patients living with a chronic inflammatory disease like rheumatoid arthritis may respond over time,” said Josef Smolen, M.D., Professor and Chairman, Department of Rheumatology, Medical University of Vienna, Vienna, Austria and lead study investigator. “Golimumab continues to be an important therapeutic option for patients living with moderately to severely active rheumatoid arthritis.”
Five-year Safety and Efficacy of Golimumab in Methotrexate-naïve Patients with Rheumatoid Arthritis: Final Study Results of the Phase 3, Randomized, Placebo-controlled GO-BEFORE Trial
An analysis using observed data from the Phase 3 GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) trial reported findings on signs and symptoms, disease activity and physical function among patients receiving SIMPONI 50 mg and methotrexate for the treatment of moderately to severely active RA through five years. Patients were randomized to receive placebo and methotrexate (n=160), SIMPONI 100 mg (n=159), SIMPONI 50 mg and methotrexate (n=159) or SIMPONI 100 mg and methotrexate (n=159). Patients receiving placebo and methotrexate crossed over to receive SIMPONI and methotrexate at weeks 28 or 52. Of the 637 methotrexate-naïve patients initially randomized in the study, 66 percent remained in the trial through five years. After the last patient completed week 52 and the study became unblinded, patients receiving placebo and methotrexate were eligible to cross over to receive SIMPONI 50 mg and methotrexate. Further, methotrexate and corticosteroid use could be adjusted and a one-time SIMPONI dose increase and decrease was permitted at the investigator’s discretion. The Phase 3 development program evaluated both SIMPONI 50 mg and 100 mg; however, the SIMPONI 100 mg dose is not approved in the United States.
Among patients randomized to receive SIMPONI 50 mg in combination with methotrexate, 85 percent (92/108) of patients achieved an ACR 20 response and 67 percent (72/108) of patients achieved ACR 50 response, defined as at least a 50 percent improvement in arthritis signs and symptoms, at week 256. The study also reported patients’ disease activity and physical function at five years as measured by Disease Activity Score (DAS) 28-C-reactive protein (CRP) and European League Against Rheumatism (EULAR) response, and the Health Assessment Questionnaire Disability Index (HAQ-DI) score. DAS28 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 (CRP), 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. EULAR good/moderate response and a HAQ-DI score improvement of at least 0.25 (minimal clinically important difference, as defined per protocol; based on an eight-point questionnaire where scores range from “0” [no disability] to “3” [completely disabled]) were observed in 93 percent (99/106) and 74 percent (78/106) of patients randomized to receive SIMPONI 50 mg with methotrexate, respectively, at week 256.
According to cumulative safety data assessed at week 268 of the study, the most common adverse events (AEs) included upper respiratory tract infection (29 percent), nausea (20 percent), bronchitis (17 percent) and increased alanine aminotransferase (16 percent). Twelve percent of patients experienced injection site reactions. Through week 268 of the study, 33 percent (204/616) of patients experienced a serious AE and 18 percent of patients enrolled in the trial discontinued SIMPONI due to an AE. Overall rates of serious infections, malignancies and death were 12 percent, 3 percent and 2 percent, respectively.
Five-year Safety and Efficacy of Golimumab in Patients with Active Rheumatoid Arthritis Despite Prior Treatment with Methotrexate: Final Study Results of the Phase 3, Randomized Placebo-controlled GO-FORWARD Trial
An analysis using observed data from the Phase 3 GOlimumab FOR Subjects With Active RA Despite Methotrexate (GO-FORWARD) trial reported findings on signs and symptoms, disease activity and physical function among patients receiving SIMPONI 50 mg and methotrexate for the treatment of moderately to severely active RA through five years. Patients were randomized to receive placebo and methotrexate (n=133), SIMPONI 100 mg and placebo (n=89), SIMPONI 50 mg and methotrexate (n=89) or SIMPONI 100 mg and methotrexate (n=89). Patients receiving placebo and methotrexate crossed over to receive SIMPONI and methotrexate at week 16 or 24. Of the 444 patients initially randomized in the study, 70 percent remained in the trial through five years. After the last patient completed week 52 and the study became unblinded, methotrexate and corticosteroid use could be adjusted, and a one-time SIMPONI dose increase and decrease was permitted at the investigator’s discretion. The Phase 3 development program evaluated both SIMPONI 50 mg and 100 mg; however, the SIMPONI 100 mg dose is not approved in the United States.
Seventy-seven percent (57/74) of patients randomized to receive SIMPONI 50 mg in combination with methotrexate achieved ACR 20, and 54 percent (40/74) of patients randomized to receive SIMPONI 50 mg with methotrexate achieved ACR 50 at week 256. The study also evaluated patients’ disease activity and physical function at five years as demonstrated by EULAR response and HAQ-DI score improvement of at least 0.25, observed in 89 percent (65/73) and 74 percent (55/74) of patients randomized to receive SIMPONI 50 mg with methotrexate, respectively.
According to cumulative safety data assessed at week 268 of the study, the most common AEs included upper respiratory tract infection (33 percent), nasopharyngitis (17 percent), bronchitis (17 percent), cough (17 percent) and injection-site reactions (9 percent). After five years, 40 percent (172/434) of patients experienced a serious AE, and 14 percent of patients discontinued SIMPONI. The rates of serious infections, malignancies and death were evaluated at 12 percent, 6 percent and 2 percent, respectively.
Five-year Safety and Efficacy of Golimumab in Patients with Active Rheumatoid Arthritis Despite Previous Anti-tumor Necrosis Factor Therapy: Final Study Results of the Phase 3, Randomized, Placebo-controlled GO-AFTER Trial
An analysis using observed data from the Phase 3 GOlimumab After Former anti-TNF Therapy Evaluated in RA (GO-AFTER) trial reported findings on signs and symptoms, disease activity and physical function among patients with moderately to severely active RA previously treated with TNF inhibitors receiving treatment with SIMPONI 50 mg through five years. Patients were randomized to receive placebo +/- DMARDs (n=150), SIMPONI 50 mg +/- DMARDs (n=147) or SIMPONI 100 mg +/- DMARDs (n=148), and those receiving placebo crossed over to receive SIMPONI 50 mg at week 16 or 24. Of the 461 patients initially randomized in the study, 40 percent remained in the trial through five years. After the last patient completed week 24 and the study became unblinded, a one-time SIMPONI dose increase and decrease was permitted at the investigator’s discretion. The Phase 3 development program evaluated both SIMPONI 50 mg and 100 mg; however, the SIMPONI 100 mg dose is not approved in the United States.
After five years, 60 percent (39/65) of patients randomized to receive SIMPONI 50 mg +/- DMARDs and 65 percent (37/57) of patients in the placebo group who crossed over to receive SIMPONI +/- DMARDs achieved ACR 20. Forty percent (26/65) of patients randomized to receive SIMPONI 50 mg +/- DMARDs achieved ACR 50 and 82 percent (53/65) of patients randomized to receive SIMPONI 50 mg +/- DMARDs achieved EULAR good/moderate response at week 256 of the study.
According to cumulative safety data assessed at week 268 of the study, the most common AEs were upper respiratory tract infection (27 percent), worsening of RA (20 percent), sinusitis (17 percent) and nasopharyngitis (17 percent). After five years, 35 percent (151/431) of patients experienced a serious AE. Rates of serious infections, malignancies and death were 14 percent, 5 percent and 2 percent, respectively.
About the Studies
GO-FORWARD, GO-BEFORE and GO-AFTER were randomized, multicenter, placebo-controlled trials evaluating the safety and efficacy of subcutaneous SIMPONI as treatment for moderately to severely active RA in multiple patient populations including those naïve to methotrexate (GO-BEFORE), those with active disease despite methotrexate (GO-FORWARD) and those who had received previous anti-TNF agents (GO-AFTER). Long-term extensions began at week 24 (GO-AFTER) or week 52 (GO-FORWARD and GO-BEFORE), with the last SIMPONI injection occurring at week 252. Observed efficacy results and cumulative safety data are reported through weeks 256 and 268, respectively.
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[1] 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 67 countries, including the United States where SIMPONI is approved by the United States Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate, active ankylosing spondylitis and moderately to severely active ulcerative colitis. SIMPONI is available either through the SmartJect® autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection. For more information about SIMPONI visit www.SIMPONI.com.
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. 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 other TNF blockers 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® have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI®, tell your doctor.
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-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.
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, or 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.
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.
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 Janssen Biotech, Inc.
Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com.
Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson & Johnson which are dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world. Follow us on Twitter at www.twitter.com/JanssenUS.
# # #
References:
[1] World Health Organization. The global burden of disease: 2004 update. Geneva: WHO Press, 2008. http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Accessed May 6, 2013.
Media Contact:
Brian Kenney
Office: 215-628-7010
Mobile: 215-620-0111
Megan Farina
Office: 215-325-6861
Mobile: 610-724-1079
Investor Contacts:
Louise Mehrotra
Johnson & Johnson
Office: 732-524-6491
Stan Panasewicz
Johnson & Johnson
Office: 732-524-2524