Prof. Ronald van Vollenhoven, Karolinska Institute, Stockholm, Sweden, presented 1-year data from the SWEFOT trial (NCT00603525), an open-label, randomized, controlled trial that was designed to compare 2 treatment strategies in rheumatoid arthritis (RA) patients who failed treatment with methotrexate (MTX) monotherapy.

In SWEFOT, 487 patients with early RA (symptom duration <1 year) received MTX monotherapy (maximum dose 20 mg/week) for a maximum of 4 months. Patients who had not achieved DAS28 <3.2 by Month 4 but who could tolerate MTX (n=258) were randomly assigned to receive one of two treatment protocols. Patients in Group 1 (n=130) received MTX plus sulfasalazine 1000 mg BID and hydroxychloroquine 400 mg daily. Patients in Group 2 (n=128) received MTX plus infliximab (3 mg/kg/infusion, rounded up to the nearest 100 mg, given at Weeks 0, 2, and 6 and every 8 weeks thereafter). DMARD dose could be adjusted for intolerance. The frequency (but not the dose) of the infliximab infusion could be increased based on response. A single switch within each group was allowed only for intolerance. Sulfasalazine and hydroxychloroquine could be replaced by cyclosporine A (2.5–5.0 mg/kg BID); infliximab could be replaced by etanercept (50 mg weekly).

The primary (EULAR good response) and secondary (EULAR moderate response, ACR responses, and others) outcomes were assessed at Month 12. Analysis was based on the intent-to-treat population (ITT). Data also were analyzed using a modified ITT (mITT) population that included only patients who received at least one dose of the study drug. For patients who discontinued during the study, nonresponder imputation was used for dichotomous variables, and last-observation-carried-forward was used for continuous variables.

At 12 months, significantly (p<0.01) more patients in Group 2 (42%) achieved a EULAR good response versus those in Group 1 (26%). The percentage of EULAR total responders also was significantly higher in Group 2 (64% vs 52% Groups 2 and 1, respectively; p<0.05). ACR 20, 50, and 70 responses are shown in Table 1.

Responses using the mITT population yielded similar results with stronger statistical significance.

“After the disease has been confirmed in a patient, we start by treating it with methotrexate,” said Prof. van Vollenhoven, who also is a member of the SWEFOT steering committee. “But for the group of patients who don't respond well to MTX, it's more effective to add a biological medicine than to combine MTX with an older drug.”