RESEARCH - Disease remission and sustained halting of radiographic progression with combination Enbrel and MTX in RA

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Arthritis Rheum. 2007 Dec;56(12):3928-39.

Disease remission and sustained halting of radiographic progression

with combination etanercept and methotrexate in patients with

rheumatoid arthritis.

van der Heijde D, Klareskog L, Landewé R, Bruyn GA, Cantagrel A, Durez

P, Herrero-Beaumont G, Molad Y, Codreanu C, Valentini G, Zahora R,

Pedersen R, MacPeek D, Wajdula J, Fatenejad S.

Department of Rheumatology, Leiden University Medical Center, Leiden,

The Netherlands. d.vanderheijde@...

OBJECTIVE: The Trial of Etanercept and Methotrexate with Radiographic

Patient Outcomes (TEMPO) is a 3-year, double-blind, multicenter study

evaluating the efficacy and safety of etanercept, methotrexate, and

the combination of etanercept plus methotrexate in patients with

active rheumatoid arthritis (RA). The results after 1 and 2 years of

the study have been previously reported. Here we provide the 3-year

clinical and radiographic outcomes and safety of etanercept,

methotrexate, and the combination in patients with RA. METHODS: In

this randomized, double-blind, multicenter TEMPO study, 682 patients

received etanercept 25 mg twice weekly, methotrexate < or =20 mg

weekly, or the combination. Key efficacy assessments included the

Disease Activity Score (DAS) and the DAS in 28 joints. RESULTS:

Combination therapy resulted in significantly greater improvement in

the DAS and in more patients with disease in remission than either

monotherapy. This finding was confirmed by longitudinal analysis;

patients receiving combination therapy were more than twice as likely

to have disease in remission than those receiving either monotherapy.

Independent predictors of remission included male sex, lower disease

activity, lower level of joint destruction, and/or better physical

function. Combination and etanercept therapy both resulted in

significantly less radiographic progression than did methotrexate (P <

0.05). Etanercept and combination treatment were well tolerated, with

no new safety findings.

CONCLUSION: Etanercept plus methotrexate showed sustained efficacy

through 3 years and remained more effective than either monotherapy,

even after adjustment for patient withdrawal. Combination therapy for

3 years led to disease remission and inhibition of radiographic

progression, 2 key goals for treatment of patients with RA.

PMID: 18050208

http://www.ncbi.nlm.nih.gov/pubmed/18050208

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