Enbrel versus MTX in patients with early RA: Two-year radiographic and clinical outcomes

July 23, 2002

Arthritis Rheum 2002 Jun;46(6):1443-50

Etanercept versus methotrexate in patients with early rheumatoid

arthritis: Two-year radiographic and clinical outcomes.

Genovese MC, Bathon JM, RW, Fleischmann RM, Tesser JR, Schiff MH,

Keystone EC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Cannon GW,

Spencer-Green G, Finck BK.

Stanford University, Stanford, California.

Objective:To compare the clinical and radiographic outcomes in patients

with rheumatoid arthritis (RA) who received monotherapy with either

etanercept or methotrexate (MTX) for 2 years and to assess the safety of

this therapy.

Methods: In the Enbrel ERA (early rheumatoid arthritis) trial, 632

patients with early, active RA were randomized to receive either

twice-weekly subcutaneous etanercept (10 mg or 25 mg) or weekly oral MTX

(mean dosage 19 mg per week) for at least 1 year in a double-blind

manner. Following the blinded phase of the trial, 512 patients continued

to receive the therapy to which they had been randomized for up to 1

additional year, in an open-label manner. Radiograph readers remained

blinded to treatment group assignment and the chronologic order of

images.

Results:At 24 months, more 25-mg etanercept patients than MTX patients

met American College of Rheumatology 20% improvement criteria (72% and

59%, respectively; P = 0.005), and more had no increase in total score

and erosion scores on the Sharp scale (P = 0.017 and P = 0.012,

respectively). The mean changes in total Sharp score and erosion score

in the 25-mg etanercept group (1.3 and 0.66 units, respectively) were

significantly lower than those in the MTX group (3.2 and 1.86 units,

respectively; P = 0.001). Significantly more patients in the 25-mg

etanercept group (55%) than in the MTX group (37%) had at least 0.5

units of improvement in the Health Assessment Questionnaire disability

index (P < 0.001). Fewer patients in the etanercept group than in the

MTX group experienced adverse events or discontinued treatment because

of adverse events.

Conclusion: Etanercept as monotherapy was safe and was superior to MTX

in reducing disease activity, arresting structural damage, and

decreasing disability over 2 years in patients with early, aggressive

RA.

PMID: 12115173

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