A new analysis demonstrated that a greater proportion of patients with moderately to severely active rheumatoid arthritis (RA) who had prior treatment with anti-tumor necrosis factor (TNF)-alpha agents and received subcutaneous injections of SIMPONI(TM) (golimumab) once every four weeks experienced significant improvements in signs and symptoms through week 24, compared with patients receiving placebo. Patients continued to receive stable doses of methotrexate, sulfasalazine and/or hydroxychloroquine if receiving them at baseline. These data were presented at the 2009 European League Against Rheumatism (EULAR) Annual Congress.
Findings from the GOlimumab After Former anti-TNF Therapy Evaluated in RA (GO-AFTER) study, demonstrated that patients previously treated with adalimumab, etanercept or infliximab responded to and tolerated SIMPONI regardless of the type of prior anti-TNF therapy, as well as the number of prior therapies or reason for discontinuation. According to the study, 39 percent of patients receiving SIMPONI whose prior anti-TNF-alpha therapy had been discontinued due to a lack of efficacy achieved at least a 20 percent improvement in arthritis symptoms (ACR 20) at week 14, compared with 18 percent of patients receiving placebo (p<0.001). Thirty-four percent of patients receiving SIMPONI whose prior anti-TNF-alpha therapy had been discontinued for all other reasons achieved ACR 20, compared with 20 percent of patients receiving placebo (p=0.027).
"Golimumab has shown promise in the treatment of rheumatoid arthritis patients who have previously discontinued other anti-TNF-alpha therapies," said Josef S. Smolen, MD, Professor and Chairman, Department of Rheumatology, Medical University of Vienna, Vienna, Austria, lead investigator. "Regardless of the reasons for discontinuation of prior anti-TNF-alpha agents, golimumab has demonstrated efficacy and tolerability, and provides hope for people struggling with rheumatoid arthritis."
Regardless of the particular anti-TNF-alpha agent previously used in treatment (adalimumab, etanercept or infliximab), the findings were consistent and showed SIMPONI to be effective in improving signs and symptoms of RA. Eighty percent of patients received prior anti-TNF-alpha therapy for at least 12 weeks and 49 percent received prior anti-TNF-alpha therapy for at least 48 weeks. At week 14, 32 percent of patients previously treated with adalimumab, 41 percent of patients previously treated with etanercept and 41 percent of patients previously treated with infliximab achieved ACR 20. At week 24, 34 percent, 44 percent and 48 percent of patients, respectively, achieved ACR 20. Patients also experienced significant improvement in disease activity at six months as measured by DAS28.
Investigators reported that the safety profile of SIMPONI among anti-TNF-alpha experienced patients in the GO-AFTER trial was similar to findings from two additional Phase 3 trials that evaluated SIMPONI in biologic-naive patients.
"The efficacy of SIMPONI demonstrated in this Phase 3 study is encouraging news for patients with moderately to severely active rheumatoid arthritis who have been previously treated with anti-TNF agents," said Robert J. Spiegel, MD, chief medical officer, Schering-Plough Research Institute. "The study demonstrates that every four-week subcutaneous injections of golimumab may benefit these patients by reducing the signs and symptoms of rheumatoid arthritis."
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