New SIMPONI (Golimumab) Data Shows Sustained Efficacy in the Treatment of Rheumatoid Arthritis

Merck & Co., Inc.Findings from an open-label, uncontrolled long-term extension of a Phase 3 registration trial demonstrated efficacy of SIMPONI in patients with moderately to severely active rheumatoid arthritis despite methotrexate therapy at two years. Results showed that reductions in signs and symptoms and improvements in physical function were maintained over two years with subcutaneous injections of SIMPONI™ (golimumab) 50 mg or 100 mg once every four weeks. These data were presented at the 2010 European League Against Rheumatism (EULAR) Annual Congress.

Long-term efficacy observed over two years
Findings from the GOlimumab FOR Subjects With Active RA Despite MTX (GO-FORWARD) study, demonstrated that patients with active rheumatoid arthritis despite methotrexate therapy sustained positive responses to SIMPONI through week 104. A total of 444 patients 18 years of age and older were randomized to one of four treatment groups: placebo plus methotrexate (group one), SIMPONI 100 mg plus placebo (group two), SIMPONI 50 mg plus methotrexate (group three), and SIMPONI 100 mg plus methotrexate (group four). At week 16, patients with less than 20 percent improvement in swollen and tender joint counts in groups one, two and three entered early escape. At week 24, patients in group one crossed over to SIMPONI 50 mg plus methotrexate. At week 52, the trial was unblinded and patients could be dose-escalated from SIMPONI 50 mg to SIMPONI 100 mg based on clinical judgment.

The findings showed that 70 of 133 patients in group one, 60 of 133 patients in group two, 57 of 89 patients in group three and 51 of 89 patients in group four achieved at least 20 percent improvement in arthritis symptoms (ACR20) at week 104. Of the patients with improved physical function as measured by the Health Assessment Questionnaire (HAQ ≥ 0.25) at week 24, 43 of 47 patients in group one, 50 of 57 patients in group two, 52 of 60 patients in group three and 53 of 60 patients in group four maintained improvement.

"Our findings add to the growing body of evidence supporting the sustained efficacy of golimumab in the treatment of rheumatoid arthritis patients over time," said Edward C. Keystone, M.D., professor, Department of Rheumatology, University of Toronto/Mount Sinai Hospital, Toronto, Canada, lead investigator. "For patients with active rheumatoid arthritis, these data provide important insights in the treatment of this debilitating disease."

Patients also experienced improvement in disease activity at two years as measured by DAS28 (CRP) response. At week 104, 93 of 133 patients in group one, 80 of 133 patients in group two, 69 of 89 patients in group three and 65 of 89 patients in group four experienced improvements in disease activity. Improvements were also demonstrated in the number of tender and swollen joints. The median percent improvement in swollen joint counts of 133 patients in groups one and two was 75 percent and 56 percent respectively, and of 89 patients in groups three and four was 83 percent and 86 percent respectively. The median percent improvement in tender joint counts of 133 patients in groups one and two was 71 percent and 60 percent respectively and of 89 patients in groups three and four was 81 percent and 79 percent, respectively.

About the GO-FORWARD Trial
GO-FORWARD is a placebo-controlled, double-blind, Phase 3 registration trial that demonstrates the efficacy and safety of an anti-TNFalpha 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.

Through two years, serious adverse events per 100 patient-years were 15, 27, 16 and 25 in the placebo plus methotrexate, SIMPONI 100 mg plus placebo, SIMPONI 50 mg plus methotrexate and SIMPONI 100 mg plus methotrexate treated patients, respectively, and serious infections per 100 patient-years were 2, 6, 4 and 6, respectively. Active tuberculosis was reported in two patients: one patient in the SIMPONI 50 mg plus methotrexate group and one patient in the SIMPONI 100 mg plus methotrexate group. There were sixteen malignancies; two patients in the methotrexate plus placebo group, three patients in the SIMPONI 100 mg plus placebo group, six patients in the SIMPONI 50 mg plus methotrexate group and five patients in the SIMPONI 100 mg plus methotrexate group. Three patients in the SIMPONI 100 mg plus placebo group died (sepsis, fulminant hepatic failure and complicated respiratory distress) and one patient in the SIMPONI 100 mg plus methotrexate group died (circulatory insufficiency).

About SIMPONI
SIMPONI is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (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 approved for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, and is available either through the SIMPONI SmartJect™ autoinjector or a prefilled syringe.

Centocor Ortho Biotech Inc. developed and discovered SIMPONI and has exclusive marketing rights to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan, where SIMPONI will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where SIMPONI will be exclusively marketed by Janssen-Cilag; and China, where SIMPONI will be exclusively marketed by Xian-Janssen.

About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic and debilitating disease that affects more than three million people in Europe. Signs and symptoms of RA include pain, stiffness and motion restriction in multiple joints. Because RA is a progressive disease, it can cause permanent joint deformity and severe disability if not diagnosed early or if initial treatment is delayed. RA can occur at any age, but is most common in adults 30-50 years old and is two to three times more prevalent in women than in men. The cause of RA is unknown, although genetic factors may contribute to the disease.

About MSD
Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health 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 policies, programs and partnerships. MSD. Be well. For more information, visit www.msd.com.

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