Combination treatment for early rheumatoid arthritis induces remission and prevents progression

July 15, 2008

Combination treatment with methotrexate and etanercept in patients with active, early, moderate-to-severe rheumatoid arthritis (RA) improves both remission and radiographic non-progression rates within one year compared with the standard treatment of methotrexate alone. This treatment also increases the ability of patients to remain in employment. These are the conclusions of authors of an Article published early Online and in an upcoming edition of The Lancet.

Remission is the best outcome for early therapy, and is best achieved by reducing or eliminating inflammation, thereby stopping radiographic progression at an early stage when the disease is most destructive and before joint damage occurs. Paul Emery, Arthritis Research Campaign Professor of Rheumatology, University of Leeds, UK and Leeds Teaching Hospitals Trust, UK, and colleagues did the COMET* study -- a randomised trial to test the effects of combination treatment with methotrexate and etanercept compared with methotrexate alone.

542 outpatients who had not previously used methotrexate and had had early moderate-to-severe RA for 3-24 months were randomly assigned to receive either methotrexate alone, raised from a starting dose of 7.5mg a week to a maximum of 20mg a week by week 8 (268 patients); or methotrexate (same dosage pattern) plus etanercept 50mg a week (274 patients). The 1-year endpoints of the trial were remission measured by the disease activity score in 28 joints (DAS28)** and radiographic non-progression measured with modified total Sharp score.***

The researchers found 50% of patients given combined treatment achieved clinical remission (and 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 non-progression, compared with 59% in the methotrexate-only group, a difference of 21% favouring combined treatment. Serious adverse events were similar between groups.

The authors say: "The COMET trial showed that patients who received combination therapy have a nearly three-fold reduction in work stoppage compared with those who took high-dose methotrexate alone. The ability to remain a productive member of the workforce has implications for patients, employers, and society as a whole. The effect of RA is especially significant for women aged 55-64 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 conclude: "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....The positive clinical outcomes in the combination treatment group also seem to determine the ability of patients to remain in employment. Furthermore, these outcomes appear to be achieved without exposing patients to significant additional risk."

In an accompanying Comment, Dr Joel Kremer, Center for Rheumatology, Albany Medical College, Albany, NY, USA, says in order to show that treatments such as the combination therapy in COMET are cost effective and efficacious in the long-term, countries must make use of national registries. He says: "Experts in health economics can apply rigorous formulae to quality of life and disability, while factoring in cost of drugs and their toxic effects, to establish whether the promising data in these investigations are sustained, and whether the new biological agents are cost effective."
-end-
Notes to editors:

*COMET= Combination of methotrexate and etanercept in early active rheumatoid arthritis

**DAS28= A composite score of disease activity based on examination of 28 joints

***modified total Sharp score= an X-ray measure of structural (bony) damage.

Professor Paul Emery, University of Leeds, UK T) +44 (0) 7876 598281 E) p.emery@leeds.ac.uk

Alternative contact Simon Jenkins, Press Office, University of Leeds, UK T) +44 (0) 113 343 5764 / +44 (0) 7791 333229 E) S.Jenkins@leeds.ac.uk

Dr Joel Kremer, Center for Rheumatology, Albany Medical College, Albany, NY, USA T) +1 518-489-4496 E) jkremer@joint-docs.com

For full paper please e-mail pressoffice@lancet.com

Lancet

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