Abstract | OBJECTIVE: METHODS: In the Treatment of Early Rheumatoid Arthritis (TEAR) trial, 755 participants with early, poor-prognosis RA were randomized to receive MTX monotherapy or combination therapy (MTX plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine). Participants randomized to receive MTX monotherapy stepped-up to combination therapy at 24 weeks if the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) was ≥3.2. RESULTS: Attrition at 24 weeks was similar in the MTX monotherapy and combination groups. Of the 370 evaluable participants in the initial MTX group, 28% achieved low levels of disease activity and did not step-up to combination therapy (MTX monotherapy group). The mean ± SD DAS28-ESR in participants continuing to take MTX monotherapy at week 102 was 2.7 ± 1.2, which is similar to that in participants who were randomized to immediate combination therapy (2.9 ± 1.2). Participants who received MTX monotherapy had less radiographic progression at week 102 as compared to those who received immediate combination therapy (mean ± SD change in modified Sharp score 0.2 ± 1.1 versus 1.1 ± 6.4). Participants assigned to initial MTX who required step-up to combination therapy at 24 weeks (72%) demonstrated similar DAS28-ESR values (3.5 ± 1.3 versus 3.2 ± 1.3 at week 48) and radiographic progression (change in modified Sharp score 1.2 ± 4.1 versus 1.1 ± 6.4 at week 102) as those assigned to immediate combination therapy. The results for either of the immediate combination approaches, whether triple therapy or MTX plus etanercept, were similar. CONCLUSION: These results in patients with early, poor prognosis RA validate the strategy of starting with MTX monotherapy. This study is the first to demonstrate in a blinded trial that initial MTX monotherapy with the option to step-up to combination therapy results in similar outcomes to immediate combination therapy. Approximately 30% of patients will not need combination therapy, and the 70% who will need it are clinically and radiographically indistinguishable from those who were randomized to receive immediate combination therapy.
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Authors | James R O'Dell, Jeffrey R Curtis, Ted R Mikuls, Stacey S Cofield, S Louis Bridges Jr, Veena K Ranganath, Larry W Moreland, TEAR Trial Investigators |
Journal | Arthritis and rheumatism
(Arthritis Rheum)
Vol. 65
Issue 8
Pg. 1985-94
(Aug 2013)
ISSN: 1529-0131 [Electronic] United States |
PMID | 23686414
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Validation Study)
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Copyright | Copyright © 2013 by the American College of Rheumatology. |
Chemical References |
- Antirheumatic Agents
- Immunoglobulin G
- Receptors, Tumor Necrosis Factor
- Sulfasalazine
- Hydroxychloroquine
- Etanercept
- Methotrexate
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Topics |
- Antirheumatic Agents
(therapeutic use)
- Arthritis, Rheumatoid
(diagnosis, drug therapy)
- Disease Progression
- Double-Blind Method
- Drug Therapy, Combination
- Etanercept
- Female
- Health Status
- Humans
- Hydroxychloroquine
(therapeutic use)
- Immunoglobulin G
(therapeutic use)
- Joints
(pathology, physiopathology)
- Male
- Methotrexate
(therapeutic use)
- Middle Aged
- Prognosis
- Receptors, Tumor Necrosis Factor
(therapeutic use)
- Severity of Illness Index
- Sulfasalazine
(therapeutic use)
- Time Factors
- Treatment Outcome
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