Golimumab with methotrexate improves markers of inflammation and structural damage in RA patients

MERCKNov 30 2010

Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of   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 is calculated from the average of three scores: 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. 

"Although not indicated in Canada to prevent structural damage, these data support the efficacy of golimumab and its effect in altering the devastating nature of RA," said Dr. Edward Keystone, Professor of Medicine, University of Toronto, one of the Canadian investigators in the studies. "Our goal in treating RA patients is to reduce their symptoms and to preserve their functional ability. These findings give important new information to rheumatologists and further support the efficacy of golimumab in inhibiting joint damage, which can really make a difference in patients' lives."

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 golimumab 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 golimumab 50 mg plus methotrexate experienced 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 group (-0.4 and 0.7, respectively).  Minimal changes in bone erosion across all treatment groups precluded the adequate evaluation of the effects of (golimumab) on bone erosion, which is consistent with previously published radiographic data.