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.
Centocor Ortho Biotech, Inc.