tREACH Study Results for Early RA Treatments

San Diego—In patients with early rheumatoid arthritis (RA), treatment with triple disease-modifying antirheumatic drug (DMARD) therapy was found superior to methotrexate monotherapy, even after 12 months of therapy. The superior benefit of triple therapy was seen independent of corticosteroids, and the study found that oral or intramuscular glucocorticoids (GCs) were equally effective as bridging therapy for these patients.

This is the conclusion of the tREACH (Treatment in the Rotterdam Early Arthritis Cohort) study undertaken by researchers in the Netherlands to assess the much debated question of what is the most appropriate initial treatment for patients with newly diagnosed RA. The study evaluated the efficacy of 3 different induction regimens for new onset RA that included an assessment of initial triple DMARD therapy versus methotrexate monotherapy, as well as an assessment of the efficacy of oral versus intramuscular GC as bridging therapies.

Patients eligible for the study were >18 years of age, had arthritis in at least 1 joint with symptoms of <1 year not due to overexertion or trauma, and were deemed to have a high probability (>70%) of progressing to persistent arthritis based on the prediction model of Visser.

In the multicenter, single-blinded study, 281 patients with recent-onset RA were randomized to 1 of the 3 induction therapy strategies: 91 patients received triple DMARD therapy (methotrexate 25 mg/week plus sulfasalazine 2 g/day plus hydroxycholorquine 400 mg/day) with intramuscular GC (methylprednisolone 120 mg; group A), 93 received triple DMARD therapy with oral GCs starting at 15 mg and tapering (group B), and 97 received methotrexate with oral GCs starting at 15 mg and tapering (group C).

Patients in the study were mostly female (68%), had an average symptom duration of 166 days, and at baseline 267 (95%) fulfilled the 2010 criteria for RA. Of these patients, 216 (77%) were anti-citrullinated protein autoantibody positive and 48 (16%) had erosions. 

Investigators examined the patients every 3 months to assess disease activity score (DAS) and functional ability through the use of the Health Assessment Questionnaire (HAQ) and area under the curve.

The study found that patients treated with triple DMARD therapy (groups A and B) had significantly lower DAS and HAQ over time than patients treated with methotrexate monotherapy (group C); DAS was -2.39 (95% confidence interval [CI], -4.77--0.00; P=.05) and mean HAQ as shown by area under the curve was -1.67 (95% CI, -3.35-0.02; P=.05). This difference between triple DMARD therapy and methotrexate monotherapy remained over time.

Radiographic progression after 1 year was 15% for group A, 30% for group B, and 18% for group C.

The study found no differences between oral or intramuscular GC bridging therapies, nor any differences in serious adverse events. In addition, the less treatment failure in patients treated with triple DMARD resulted in 40% fewer prescriptions of biologic agents needed after 12 months.

Pascal de Jong, PhD, Department of Internal Medicine, Erasmus MC, Rotterdam, the Netherlands, lead investigator of the stud, presented the study results at a press conference and scientific session at the ACR/ARHP meeting. Dr. de Jong said these results indicate that triple DMARD therapy should be recommended over methotrexate monotherapy as first-line treatment in newly diagnosed RA patients.