New Magnetic Resonance Imaging (MRI) Data Show Efficacy of SIMPONI® in Treatment of Rheumatoid Arthritis

/PRNewswire/ -- 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 <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.

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FDA Approves First Imaging Agent to Enhance Scans of Blood Flow

The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels.

Although MRA can be performed without the use of a contrast imaging agent, Vasovist administration provides a clearer image in patients who are suspected of having blockages or other problems with the blood vessels in their abdomen or limbs. The MRA is performed using magnetic resonance imaging (MRI), which relies on magnetic fields to create highly detailed images of the inside the body.

"This MRA contrast imaging agent provides clinicians with a much clearer scan of blood vessels, compared to MRA without contrast, even in vessels that are difficult to scan because they twist and turn in the body," said John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, FDA.

When blood vessels are scanned using MRA without any contrast, radiologists are unable to interpret the images about 10 percent to 30 percent of the time. As a result, radiologists have typically used X-rays to detect blood vessel abnormalities. But this is a lengthy procedure and requires sticking a needle into an artery to inject the X-ray dye, a procedure that may result in injury to vessel walls, blood clots, allergic reactions and potential kidney damage. Vasovist is injected into a peripheral vein and no artery is punctured, thus the potential risks are fewer.

The active substance in Vasovist is gadolinium, a rare earth metal element that is detected by MRI scanners. When injected, gadoliunium interacts with water molecules in the body, giving a stronger signal and, in turn, a better picture.

The safety and efficacy of Vasovist was established in two clinical studies of patients with known or suspected aortoiliac disease --- plaque buildup in the arteries going to the legs. In the studies, patients underwent MRA with and without Vasovist and their scans were compared to standard X-ray pictures using contrast. MRA with Vasovist detected more arterial disease than MRA performed without Vasovist and the pictures were of improved technical quality.

The primary safety risks for Vasovist are allergic reactions and n ephrogenic systemic fibrosis, a rare syndrome that involves the thickening of the skin, joints, eyes and internal organs. The FDA issued a warning about this syndrome in May 2007 and information about it is included in a boxed warning for all drugs containing gadolinium, including Vasovist. The warning can be found here:
http://www.fda.gov/cder/drug/InfoSheets/HCP/gcca_200705.htm

Vasovist Injection is manufactured by EPIX Pharmaceuticals Inc., Lexington , Mass.

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