For patients with early rheumatoid arthritis, combined therapy with methotrexate and infliximab (Remicade) is more effective than treatment with methotrexate alone, according to a new study.

In a multicenter study involving 1,049 patients with active early-stage rheumatoid arthritis, methotrexate was given with one of two doses of infliximab, or placebo.

According to a report in Arthritis & Rheumatism, infliximab or placebo was given at the start of the trial, after 2 weeks, 6 weeks and then every 8 weeks for 46 weeks. None of the patients had been treated in the past with either drug.

Study leader Dr. E. William St. Clair of Duke University Medical Center in Durham, North Carolina, and colleagues report that at week 54, both the lower- and higher-dose infliximab groups had American College of Rheumatology improvements of 38.9 percent and 46.7 percent, respectively, compared with 26.4 percent improvement in the placebo group.

Also, the researchers said, patients who received infliximab along with methotrexate had less evidence of disease progression on X-rays and significantly greater improvements in physical function.

Patients taking infliximab, however, had a higher rate of serious infections.

The investigators point out that their results “also show that a significant proportion of patients with early rheumatoid arthritis can achieve disease control for one year by taking methotrexate alone.”

“Thus,” they conclude, “for the individual patient, the potential incremental benefits of the combination approach must be carefully weighed against the possibility of greater toxicity.”

Infliximab alone, or combined with methotrexate, is currently approved in the US for the treatment of moderate to severe rheumatoid arthritis.

SOURCE: Arthritis &Rheumatism, November 2004.