Healthcare Industry News: Methotrexate
News Release - November 8, 2010
New Magnetic Resonance Imaging (MRI) Data Show Efficacy of SIMPONI(R) in Treatment of Rheumatoid ArthritisResults Presented from Largest Prospective Trial Program Utilizing MRI Assessment as Diagnostic Measure of Anti-TNF Benefit
ATLANTA, Nov. 8, 2010 -- (Healthcare Sales & Marketing Network) -- Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of SIMPONIŽ (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 <0.001) and -0.7 (p = 0.016), respectively], compared with patients receiving placebo plus Methotrexate (-1.0, -0.3 and -0.2, respectively).
In a second study, GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD), patients receiving SIMPONI 50 mg plus Methotrexate experienced significant improvements in synovitis and bone edema [-1.9 (p < 0.001) and -2.6 (p < 0.001), respectively] at week 24 when compared with the placebo plus Methotrexate group (-0.4 and 0.7, respectively). Minimal changes in bone erosion across all treatment groups (mean change ranging from -1.1 to 0.4) precluded the adequate evaluation of the effects of SIMPONI on bone erosion, which is consistent with previously published radiographic data.
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-naīve 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.
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. A once-monthly subcutaneous anti-TNF-alpha therapy with marketing authorizations in the Unites States, Europe and Canada, SIMPONI is approved for the treatment of moderately to severely active RA in combination with Methotrexate, active psoriatic arthritis and active ankylosing spondylitis. SIMPONI is available either through the SIMPONI SmartJect autoinjector or a prefilled syringe. For more information about SIMPONI, visit www.SIMPONI.com.
Centocor Ortho Biotech Inc. discovered and developed SIMPONI and has exclusive marketing rights to the product in the United States.
Important Safety Information
SIMPONIŽ (golimumab) is a prescription medicine. SIMPONIŽ 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 SIMPONIŽ 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 SIMPONIŽ 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
- 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
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 SIMPONIŽ 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 SIMPONIŽ. Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with SIMPONIŽ. 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
- muscle aches
- dark urine
- clay-colored bowel movements
- stomach discomfort
- skin rash
Rarely, people using TNF blockers, including SIMPONIŽ, 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 SIMPONIŽ. 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 SIMPONIŽ such as hives, swollen face, breathing trouble, chest pain.
Common side effects of SIMPONIŽ include: upper respiratory tract infection, nausea, abnormal liver tests, skin reaction at site of injection, high blood pressure, flu, and cold sores.
Please read the Medication Guide for SIMPONIŽ 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 Magnetic Resonance Imaging Substudies
All patients from each substudy site were eligible for substudy participation. MRIs of the patients' dominant wrists and metacarpophalangeal joints were obtained at baseline and weeks 12, 24, 52, and 104 using 1.5T MRI with contrast enhancement, with images scored by two independent expert readers blinded to image time point or sequence, patient identity, or treatment group. MRI results are demonstrated using the Rheumatoid Arthritis MRI Scoring (RAMRIS), which comprises three scores: synovitis (0-21), bone edema (osteitis) (0-69) and bone erosions (0-230), all calculated to assess the patient. Results through week 24 were presented.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability. The Arthritis Foundation estimates that approximately 1.3 million people in the United States are living with RA, the majority of whom are women. For more information visit the Arthritis Foundation.
About Centocor Ortho Biotech, Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology, and oncology. Built upon a pioneering history, Centocor Ortho Biotech harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates, and healthcare professionals have access to the latest treatment information, support services, and quality care. For more information about Centocor Ortho Biotech, visit www.CentocorOrthoBiotech.com.
Source: Centocor Ortho Biotech
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