RESEARCH - Comparison of Enbrel and MTX, alone and combined, in RA: the TEMPO study

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Arthritis Rheum. 2006 Mar 29;54(4):1063-1074 [Epub ahead of print]

Comparison of etanercept and methotrexate, alone and combined, in the

treatment of rheumatoid arthritis: Two-year clinical and radiographic

results from the TEMPO study, a double-blind, randomized trial.

van der Heijde D, Klareskog L, -Valverde V, Codreanu C, Bolosiu H,

Melo-Gomes J, Tornero-Molina J, Wajdula J, Pedersen R, Fatenejad S.

University Hospital, Maastricht, The Netherlands.

OBJECTIVE: To evaluate the efficacy, including radiographic changes, and

safety of etanercept and methotrexate (MTX), used in combination and alone,

in patients with rheumatoid arthritis (RA) in whom previous treatment with a

disease-modifying antirheumatic drug other than MTX had failed. METHODS:

Patients with RA were treated with etanercept (25 mg subcutaneously twice

weekly), oral MTX (up to 20 mg weekly), or combination therapy with

etanercept plus MTX through a second year, in a double-blinded manner.

Clinical response was assessed using American College of Rheumatology (ACR)

criteria and the Disease Activity Score (DAS), in a modified intent-to-treat

analysis with the last observation carried forward (LOCF) and in a

population of completers. Radiographs of the hands, wrists, and forefeet

were scored for erosions and joint space narrowing at annual intervals.

RESULTS: A total of 503 of 686 patients continued into year 2 of the study.

During the 2 years, significantly fewer patients receiving combination

therapy withdrew from the study (29% of the combination therapy group, 39%

of the etanercept group, and 48% of the MTX group). Both the LOCF and the

completer analyses yielded similar results. The ACR 20% improvement (ACR20),

ACR50, and ACR70 responses and the remission rates (based on a DAS of <1.6)

were significantly higher with combination therapy than with either

monotherapy (P < 0.01). Similarly, improvement in disability (based on the

Health Assessment Questionnaire) was greater with combination therapy (P <

0.01). The combination therapy group showed significantly less radiographic

progression than did either group receiving monotherapy (P < 0.05);

moreover, radiographic progression was significantly lower in the etanercept

group compared with the MTX group (P < 0.05). For the second consecutive

year, overall disease progression in the combination therapy group was

negative, with the 95% confidence interval less than zero. Adverse events

were similar in the 3 treatment groups.

CONCLUSION: Etanercept in combination with MTX reduced disease activity,

slowed radiographic progression, and improved function more effectively than

did either monotherapy over a 2-year period. No increase in toxicity was

associated with combination treatment with etanercept plus MTX.

PMID: 16572441

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6572441

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