LONDON -- July 15, 2008 -- Methotrexate in combination with etanercept improves remission and radiographic nonprogression rates in patients with early, moderate to severe rheumatoid arthritis (RA) within 1 year compared with treatment of methotrexate alone, according to study published early online and in an upcoming edition of The Lancet.
This combination treatment also increases the ability of patients to remain a productive member of the workforce, which has implications for patients, employers, and society as a whole, according to the authors.
Paul Emery, University of Leeds and Leeds Teaching Hospitals Trust, Leeds, United Kingdom, and colleagues, did the Combination of Methotrexate and Etanercept in Early Active Rheumatoid Arthritis (COMET) study to test the effects of combination treatment with methotrexate and etanercept compared with methotrexate alone.
The randomised trial included 542 outpatients who had not previously used methotrexate and had early moderate to severe RA for 3 to 24 months. Patients were randomised to receive either methotrexate 7.5 mg a week, to a maximum of 20 mg a week by week 8 (n = 268), or methotrexate (same dosage pattern) plus etanercept 50 mg a week (n = 274).
The 1-year endpoints of the trial were remission measured by the disease activity score in 28 joints (DAS28) and radiographic nonprogression measured with modified total Sharp score.
Researchers found that 50% of patients given combination treatment achieved clinical remission (94% had a good/moderate response) compared with 28% given methotrexate alone, making those given combined treatment almost twice as likely to achieve remission.
In the combined treatment group, 80% of patients achieved radiographic nonprogression, compared with 59% in the methotrexate-only group, a difference of 21% favouring combined treatment. Serious adverse events were similar between groups.
"The COMET trial showed that patients who received combination therapy have a nearly 3-fold reduction in work stoppage compared with those who took high-dose methotrexate alone. The effect of RA is especially significant for women aged 55 to 64 years, because they have a high incidence of stopping work early ... nearly a quarter of patients who were in employment at baseline in the COMET trial had stopped working at least once by the end of 1 year compared with about a tenth in the combination group," the authors wrote.
"The results of the COMET trial suggest that remission is an achievable goal in patients with early severe RA within the first year of therapy with etanercept plus methotrexate. Furthermore, these outcomes appear to be achieved without exposing patients to significant additional risk."
SOURCE: The Lancet
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