Methotrexate monotherapy, combination therapy yield similar 1-year remission rates in early inflammatory arthritis

Patients taking methotrexate monotherapy and those taking methotrexate plus etanercept had similar rates of remission at 1 year, although those on combination therapy responded more quickly, a new study has found.

U.K. researchers conducted a 78-week multicenter, randomized, placebo-controlled superiority trial in patients 18 to 80 years of age with early inflammatory arthritis who had not previously taken disease-modifying antirheumatic drugs (DMARDs). Patients were randomly assigned to receive methotrexate plus etanercept or methotrexate plus placebo for 52 weeks. All patients had injections stopped at week 52, but injections were stopped early in patients who had no tender or swollen joints for more than 26 weeks. Methotrexate was weaned in patients who had no tender or swollen joints more than 12 weeks after injections were stopped. The study's primary end point was lack of tender or swollen joints at week 52. The results were published online March 13 by Annals of Rheumatic Diseases.

One hundred ten patients were included in the study. At week 52, no statistically significant difference was observed in the primary end point. The percentage of patients with no tender or swollen joints was 32.5% in the combination group and 28.1% in the monotherapy group (adjusted odds ratio, 1.32 [95% CI, 0.56 to 3.09]; P=0.522). In addition, secondary end points, including remission as defined by the 2011 American College of Rheumatology/European League Against Rheumatism criteria, did not differ between groups at week 52 or at week 78. More people in the combination group had a clinical response to treatment at week 2 and week 12 compared with the monotherapy group (adjusted odds ratios, 8.87 [95% CI, 2.53 to 31.17] and 2.49 [95% CI, 1.12 to 5.54]; P=0.001 and 0.026, respectively).

The authors noted that their study did not examine other available therapies and that some data were missing. However, they concluded that although patients receiving methotrexate plus etanercept had a faster response to treatment than those receiving methotrexate alone, the two therapies achieved similar effects at 1 year. The authors said their results confirm the benefit of early methotrexate treatment and dose escalation in patients with inflammatory arthritis.

“While earlier clinical responses were seen with [methotrexate plus etanercept], with maintenance of clinical and imaging responses in the majority of patients when stopping [etanercept], the value of this combination, particularly in the context of cost effectiveness, needs to be considered,” the authors wrote. “Ideally, determining which patients would benefit significantly and in the longer term with initial intensive induction therapy with a biological DMARD with the possibility of biologic or even drug-free remission would be of importance.”