Phase III GO-FURTHER trial shows Simponi (Janssen Biotech) significantly improved Rheumatoid Arthritis

Phase III study findings show that patients with active moderate to severe Rheumatoid Arthritis (RA) who received Simponi (golimumab), from Janssen Biotech, demonstrated improvements in signs and symptoms and disease activity. Investigators reported nearly 60 percent of patients receiving Simponi achieved a 20 percent improvement in arthritis signs and symptoms at week 14, the study's primary endpoint, and more than 80 percent of patients demonstrated meaningful improvements in disease activity as assessed by European League Against Rheumatism (EULAR) criteria at week 14. In the GO-FURTHER trial, patients with active RA despite treatment with methotrexate were randomized 2:1 to receive a 30 (+/- 10) minute infusion of Simponi 2 mg/kg (n=395) or placebo (n=197) plus methotrexate at weeks 0, 4 and then every 8 weeks. At week 24, 63 percent of patients receiving Simponi achieved an American College of Rheumatology criteria ACR 20 response versus 32 percent of patients receiving placebo, and 35 percent of patients receiving Simponi achieved an ACR 50 response versus 13 percent of patients receiving placebo. Patients receiving Simponi also achieved clinically relevant improvements in physical function, as measured by the Health Assessment Questionnaire vs placebo (week 24: 68 percent vs. 45 percent). Serious adverse effects were reported in 53 percent of patients receiving Simponi and 49 percent of patients receiving placebo at week 24. Results were presented at the 2012 EULAR Annual Congress.