Adverse events were relatively similar across the four patient groups. Through week 24, serious infections were reported in two, one, one and four percent of Groups 1-4, respectively. Serious adverse events were reported in seven percent, three percent, six percent and six percent of patients in Groups 1-4, respectively.
At week 52, four patients had reported malignancies; two patients developed breast cancer, one patient developed Hodgkin's disease and one patient was diagnosed with squamous cell carcinoma of the lip. One patient developed bone tuberculosis at week 52. Two patients had died by week 52; one patient died as a result of post-surgery cardiac arrest and another patient committed suicide.
GO-FORWARD, a Phase 3, multi-center clinical trial included 444 patients with active RA. Adult patients with more than four tender and swollen joints, despite methotrexate therapy, were randomly assigned to receive SIMPONI (50 or 100 mg) plus methotrexate, SIMPONI 100 mg plus placebo or placebo plus methotrexate at weeks 0, 4, 8, 12, 16 and 20. Data were assessed at weeks 14 and 24. The co-primary endpoints were percentage of patients achieving ACR 20 response at week 14 and improvement from baseline in HAQ at week 24.
Through week 24, 68 percent of patients in both the combined SIMPONI plus methotrexate groups and the placebo plus methotrexate group experienced at least one adverse event. Nine percent of patients in the combined SIMPONI plus methotrexate groups experienced a serious adverse event compared with four percent of patients receiving placebo plus methotrexate. Three percent of patients in the combined SIMPONI plus methotrexate
|SOURCE Centocor Ortho Biotech Inc.|
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