Background The first year of this 2-year study of patients with early erosive RA (mean disease duration 1 year) demonstrated that ENBREL 25 mg twice weekly gave a more rapid clinical response and was more effective in preventing erosions than high dose (median 20 mg/wk) oral MTX.1
Objectives To evaluate safety, clinical improvement, and radiographic outcomes in patients receiving ENBREL or MTX for up to 2 years.
Methods Patients enrolled in this 2-year study continued to receive the therapy to which they had been randomised in an open-label fashion after the study was unblinded (at a mean of 17.3 months). The 2-year endpoints were ACR responses (using last on-drug observation carried forward analyses) and change in Sharp score. Readers were blinded to treatment and chronological order of the x-rays. All 632 patients were included in the analyses.
Results 154 of 207 patients (74%) who received ENBREL 25 mg completed 2 years of treatment, compared to 129 of 217 patients (59%) who received MTX. Twice as many patients (12%) discontinued MTX for adverse events as did those taking ENBREL. The ACR 20 response at 2 years was 72% in those randomised to ENBREL and 59% in those randomised to MTX (P = 0.005). Radiographic evaluations demonstrated that ENBREL 25 mg was superior to MTX in arresting radiographic progression over the 2-year period. Mean (median) changes in total Sharp score were 1.3 (0) and 3.2 (0.5) units in the ENBREL 25 mg and MTX groups, respectively (P = 0.001) and changes in erosion score were 0.7 (0) and 1.9 (0) units, respectively (P = 0.001). ENBREL 25 mg prevented radiographic progression in 63% of patients, compared to 51% of MTX patients who did not progress (P = 0.017). ENBREL 25 mg was also superior to the 10 mg dose in inhibiting radiographic progression. Significantly more ENBREL 25 mg patients than MTX patients had a clinically meaningful (at least 0.5 units) improvement from baseline in HAQ disability score. ENBREL continued to be well tolerated with over 2 years of exposure.
Conclusion This 2-year study demonstrated that ENBREL was superior to MTX in reducing clinical signs and symptoms of RA and inhibiting radiographic progression.
Bathon JM, Martin RW, Fleischmann RM, et al. NEJM 2000;343:1586–93
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