New Magnetic Resonance Imaging (MRI) Data Show Efficacy Of SIMPONI® In Treatment Of Rheumatoid Arthritis

Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of SIMPONI® (golimumab) 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate. Changes in disease activity were measured using the Rheumatoid Arthritis MRI Scoring (RAMRIS) system, which assesses three components: synovitis, bone edema (osteitis) and bone erosions. Changes in RAMRIS scores were observed as early as week 12 and continued through week 24. These data were presented at the largest rheumatology medical meeting in the United States.


"MRI assessment has previously been demonstrated to show greater sensitivity than x-ray in detecting changes in inflammation and the structural integrity of the bone. The findings from a randomized controlled trial with a large number of patients show the value of this diagnostic tool in its ability to monitor disease progression" said Dr. Paul Emery, head of the Academic Unit of Musculoskeletal Medicine at the University of Leeds and lead study investigator. "The ultimate goals of inhibiting joint damage are to both reduce the symptoms that patients with RA experience and also to preserve patients' functional ability (which is correlated with early structural changes). These findings present important new information for rheumatologists and further support the substantial efficacy SIMPONI demonstrated in multiple Phase 3 registration trials in the treatment of this chronic disease."


Investigators reported that at week 24 of the GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study, patients with RA receiving SIMPONI 50 mg plus methotrexate showed significant improvements in synovitis, bone edema and bone erosions [-2.2 (P = 0.011), -2.5 ( p







In September 2010, Centocor Ortho Biotech Inc. announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the SIMPONI physician label to include inhibiting the progression of structural damage in the treatment of moderately to severely active RA.


About GO-BEFORE study


GO-BEFORE, a Phase 3, multi-center, double-blind, placebo-controlled study included 637 methotrexate-na??ve adults with rheumatoid arthritis (RA) and was designed to compare American College of Rheumatology (ACR 50) response at week 24 in patients receiving SIMPONI plus methotrexate compared with patients receiving placebo plus methotrexate. Patients with active RA who had more than four tender and swollen joints were included in the multicenter study. Patients were randomly assigned into four groups: placebo every four weeks plus methotrexate 20 mg per week, SIMPONI 100 mg every four weeks plus placebo capsules every week, SIMPONI 50 mg every four weeks plus methotrexate 20 mg per week, and SIMPONI 100 mg every four weeks plus methotrexate 20 mg per week. Most patients randomized to the placebo plus methotrexate group began receiving SIMPONI 50 mg plus methotrexate at week 52.


About GO-FORWARD study


GO-FORWARD is a multi-center, placebo-controlled, double-blind, Phase 3 registration trial that demonstrated the efficacy and safety of SIMPONI in 444 patients with active rheumatoid arthritis despite methotrexate therapy. The co-primary endpoints were percentage of patients achieving ACR 20 response at week 14 and improvement from baseline in the Health Assessment Questionnaire (HAQ) at week 24. At week 24, all patients receiving placebo plus methotrexate began receiving SIMPONI 50 mg plus methotrexate.


Centocor Ortho Biotech Inc. discovered and developed SIMPONI and has exclusive marketing rights to the product in the United States.


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), 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 may 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



-- skin or eyes look yellow



-- little or no appetite



-- vomiting



-- muscle aches



-- dark urine



-- 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. 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.


Liver problems can happen in people using TNF blockers. 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 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.


Common side effects of SIMPONI® include: upper respiratory tract infection, nausea, abnormal liver tests, skin reaction at site of injection, high blood pressure, flu, and cold sores.


Source: Centocor Ortho Biotech, Inc


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