Adding etanercept (Enbrel) to methotrexate therapy for early rheumatoid arthritis (RA) resulted in higher rates of both remission and radiographic nonprogression in a recently reported clinical trial.
Half of patients given combined treatment achieved clinical remission within a year compared with 28% given methotrexate alone. In addition, 80% of these patients achieved radiographic nonprogression compared with 59% of the monotherapy group (Lancet. 2008;372:375-382).
Led by researchers at the University of Leeds in the United Kingdom, this COMET study was funded by Wyeth, which markets Enbrel in the United States. The 542 participants were enrolled at 70 sites in Europe, Latin America, Asia, and Australia from October 2004 to February 2006. All had had moderate-to-severe RA for 3-24 months, and none had taken methotrexate before.
Subjects were randomly assigned to either oral methotrexate alone, titrated up from 7.5 mg/week to a maximum of 20 mg/week after eight weeks, or methotrexate at the same titration plus subcutaneous etanercept 50 mg/week.
More than 130 patients dropped out of the study for various reasons, including 62 who experienced adverse events, which were similar between the two groups. Remission was measured with the disease activity score in 28 joints (DAS28), and radiographic nonprogression was measured with modified total Sharp score.
“Almost two thirds of patients in the combination group achieved low disease activity (DAS28,<3.2),” the researchers report. “In fact, 59% of patients on combination therapy had no swollen joints at week 52, and over half of patients on combination therapy had functional ability comparable to that in the healthy population.
“Results suggest that remission is an achievable goal in patients who have early severe RA within the first year of therapy with etanercept plus methotrexate,” the authors conclude. “Furthermore, these outcomes appear to be achieved without exposing patients to significant additional risk.”