Patients with active moderate to severe rheumatoid arthritis (RA) inadequately responding to either etanercept (Enbrel, from Amgen/Pfizer) or adalimumab (Humira, from Abbott Labs) and who were actively switched to Remicade (infliximab) from Johnson & Johnson (NYSE: JNJ) subsidiary Centocor Ortho Biotech, demonstrated significant improvement from baseline at week 10, and sustained response through week 26 in an open label study. These week 26 results from the RESTART Phase IV study were presented for the first time at the largest rheumatology medical meeting in the USA.
"These findings offer new insights into actively switching patients not responding to one TNF [tumor necrosis factor] blocker to another therapy in the class, and in this case Remicade,” said Roy Fleischmann, University of Texas/Southwestern Medical Center and lead investigator. "The data from the RESTART study show that there are patients switched to Remicade who demonstrate immediate benefits, including improvements in disease activity and physical function," he added.
Patients who had an inadequate response (as measured by Disease Activity Score (DAS) 28 of at least 3.6 and at least six swollen and six tender joints) while receiving methotrexate and either etanercept or adalimumab were maintained on their stable dose of methotrexate and were actively switched to Remicade 3mg/kg. Patients who did not achieve or lost response had their dose titrated by 2mg/kg.
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