New MRI Data Confirm Simponi (Golimumab) Efficacy in Treatment of Rheumatoid Arthritis

MONTREAL, Nov. 30 /CNW/ - 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.

About GO-BEFORE study GO-BEFORE, a Phase 3, multi-center, double-blind, placebo-controlled study included 637 methotrexate-naïve adults with rheumatoid arthritis (RA) and was designed (primary endpoint) to compare ACR 50 response at week 24 in patients receiving golimumab 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; Group 1 included patients receiving placebo every four weeks plus methotrexate 20 mg per week; Group 2 included patients receiving golimumab 100 mg every four weeks plus placebo every week; Group 3 and Group 4 included patients receiving golimumab 50 mg every four weeks plus methotrexate 20 mg per week and golimumab100 mg every four weeks plus methotrexate 20 mg per week, respectively. The study was also designed (primary endpoint) to assess the inhibition of structural damage at 52 weeks. The safety profile of golimumab, as well as other secondary endpoints were also assessed. The long-term extension study will start at Week 52 and is expected to last approximately five years.

About GO-FORWARD study GO-FORWARD is a placebo-controlled, double-blind, Phase 3 registration trial that demonstrates the efficacy and safety of an anti-TNF alpha agent in 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 HAQ at week 24. For the trial extension, analyses were based on intent-to-treat population with last observation carried forward for missing data. The study is also expected to last approximately five years.

About Magnetic Resonance Imaging Substudies All patients from study sites, selected for their MRI capability, were eligible for this substudy. 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 were 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). Results through week 24 were presented.

About Simponi™ 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. The first once-monthly subcutaneous anti-TNF-alpha therapy, SIMPONI™ is indicated in Canada to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate), moderately to severely active psoriatic arthritis and active ankylosing spondylitis, and is available as a SIMPONI®™ SmartJect™ autoinjector or a pre-filled syringe.

Centocor Ortho Biotech Inc. discovered and developed SIMPONI™.

SIMPONI™ is contraindicated in patients with severe infections such as sepsis, tuberculosis and opportunistic infections and in patients who are hypersensitive to golimumab, latex or any other ingredient in the formulation or component of the container. Serious infections leading to hospitalization or death, including sepsis, tuberculosis, invasive fungal, and other opportunistic infections have been observed with the use of TNF antagonists including SIMPONI™. Lymphoma and other malignanices, some fatal, have been reported in children and adolescent patients treated with TNF-blockers. The potential role of TNF-blocking therapy in the development of malignancies is not known. Please refer to the Product Monograph for complete prescribing information. Please refer to the SIMPONIä Product Monograph for safety information regarding congestive heart failure, neurologic events, and hematologic warnings and for complete prescribing information.

About Merck Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit <http://www.merck.com/> www.merck.com<http://www.merck.com>.

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™SIMPONI and SmartJect are registered trademarks of Centocor Ortho Biotech Inc., used under licence by Schering-Plough Canada Inc.

For further information: Media Contacts: Mona Aubin Julie Holroyde Merck 514-428-3768 mona.aubin@merck.com

Posted: November 2010

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