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Combined Etanercept/Methotrexate Controls Rheumatoid Arthritis Disease Activity More Effectively than Monotherapy with Either Medication

A combination of etanercept and methotrexate more effectively controls rheumatoid arthritis disease activity and slows joint damage than does treatment with either medication individually, according to the findings of the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO).

"Additionally, just over a third of patients treated with the combination achieved remission at 52 weeks compared with an eighth of those given methotrexate and about a sixth of those given etanercept," reports Lars Klareskog, MD, Karolinska Institute/Karolinska Hospital, Stockholm, Sweden, and colleagues.

The researchers randomly assigned patients, 18 years or older who had active, adult onset rheumatoid arthritis from 6 months to 20 years and an unsatisfactory response to previous antirheumatic drugs other than methotrexate: 223 received subcutaneous etanercept at 25 mg twice weekly, 228 received oral methotrexate up to 20 mg weekly, and 231 received these 2 medications combined. The groups had similar baseline disease characteristics and demographics.

The researchers assessed clinical response according to American College of Rheumatology (ACR) criteria. The primary efficacy endpoint, the numeric index of the ACR response (ACR-N) area under the curve (AUC) over the first 24 weeks of treatment, was greater - 18.3%-years in the combination group and 14.7%-years in the etanercept group - compared with 12.2%-years in the methotrexate group.

The proportion of patients achieving ACR20, ACR50, and ACR70 at week 52 was consistently higher in the combination group than the etanercept or the methotrexate groups. Likewise, the combination therapy resulted in a lower mean disease activity score - 2.3 - compared with 3.0 in both the etanercept and methotrexate groups.

After 52 weeks of therapy 35% of the combination group achieved remission, defined as disease activity score of less than 1.6, compared with 16% of the etanercept and methotrexate groups.

Of patients without disease progression at 52 weeks, defined as a total Sharp score of 0.5 or less, 80% received combination therapy compared with 57% in the etanercept and 68% in the methotrexate groups. The investigators also note that the proportion of patients with radiographic progression of more than the smallest detectable difference at 52 weeks was a mean of 2.8% in the combination group compared with 4.2% in the etanercept and 11.8% in the methotrexate groups.

Adverse events were similar in all groups but just 6 patients in the combination group discontinued treatment compared with 16 in the etanercept and 21 in the methotrexate groups.

"Concurrent initiation and use of the combination of etanercept and methotrexate," the authors conclude, "brings us closer to the goals of antirheumatic treatment, specifically the achievement of clinical remission and repair of structural damage."

Lancet 2004;363:675-81.

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