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Purpose: No direct data compares triple DMARD (methotrexate [MTX], sulfasalazine [SSZ], hydroxychloroquine [HCQ]) to MTX + anti-TNF therapy (etanercept) in patients with early RA. The relative benefit of a strategy of either combination vs MTX monotherapy with step-up after 6 months is also uncertain. The TEAR trial evaluates both issues.
Methods: The investigator-initiated, multi-center, randomized TEAR trial began in 2004 and enrolled 755 participants to compare immediate (I) vs step-up (S) strategy with MTX, etanercept (E) and triple DMARD (T) in 4 arms: immediate MTX + E (IE) or triple therapy (IT); step-up from MTX to MTX+E (SE) or to T (ST). In SE/ST, if DAS28 ≥ 3.2 at 6 months of MTX, patients were blindly stepped-up to IE/IT. Inclusion criteria: disease duration ≤ 3yrs, diagnosis by ACR criteria; RF+, CCP+ or ≥ 2 radiographic erosions; ≥ 4 tender and 4 swollen joints; MTX naïve. The primary endpoint was mean DAS28 from weeks 48-102. Other endpoints: ACR 20, 50, 70; discontinuation for lack of efficacy, DAS28 remission, QOL and Radiographic progression.
Results: Subjects were 72% female; 80% Caucasian, 11% African American; with a mean age at entry of 49±13 yrs, with 3.6±6.5 months since diagnosis, 90% RF+. The mean DAS28 at entry 5.8±1.1; 28 joint count: 14.3±6.8 painful and 12.8±6.0 swollen joints. As shown in the Table, during the second year of treatment, patients randomized to S arms had clinical responses that were not statistically different than those who received I combination therapy, regardless of treatment arm (p-values: I vs S: 0.95, E vs T: 0.23). There were significant differences in the outcome of ACR response at 6 months between treatment arms: patients initially receiving IE or IT were significantly more likely to achieve an ACR 20/50/70 response at 6 months than those randomized to step-up arms (all p < 0.0001), regardless of treatment (E vs T).
Conclusions: A 2-year double-blinded trial of early RA patients found no differences in the mean levels of DAS28 during weeks 48-102 among patients randomized to etanercept or triple DMARD, regardless of whether they received immediate combination treatment or MTX monotherapy with a step-up. At 6 months immediate combination treatment with either strategy was more effective than MTX monotherapy; however, there were no significant differences in groups at 2 years. Initial use of MTX monotherapy with the addition of SSZ/HCQ or etanercept, if necessary after 6 months, is a reasonable therapeutic strategy for early RA.
Treatment arm | DAS28 | ACR response at 6 months | ||
ACR 20, % | ACR50, % | ACR70, % | ||
IE | 3.0 ± 1.4 | 63.6 | 35.5 | 13.1 |
IT | 2.9 ± 1.5 | 64.0 | 38.6 | 11.4 |
SE | 3.1 ± 1.4 | 45.2 | 22.1 | 3.2 |
ST | 2.8 ± 1.3 | 47.7 | 21.5 | 4.7 |