New data show patients with moderate to severe early rheumatoid arthritis (RA) initially treated with the combination of Humira and methotrexate (MTX) for two years had greater inhibition of radiographic progression at five years than patients initially treated with either monotherapy. Patients who completed the two-year, double-blind period of the study and chose to enrol in the open-label extension of the study received Humira 40 mg every other week for an additional three years. More than half of patients who were initially receiving combination therapy showed no further joint damage at five years. The results were presented this week at the European League Against Rheumatism annual congress in Copenhagen.

"Data from the Premier trial show us that with early diagnosis and aggressive treatment of rheumatoid arthritis, joint damage can be prevented and patients can maintain use of their joints for up to five years," said Desiree van der Heijde, of the Leiden University Medical Center in the Netherlands and lead study investigator.

Early RA patients were defined as those who had been diagnosed with the disease for less than three years. The patients who were on combination therapy at the start of the study had less joint damage progression at year five than patients who started on either Humira or MTX therapy alone. Joint damage was measured using the modified total Sharp score (mTSS). With mTSS, a higher score indicates greater damage. The increase in mTSS at year five in the combination group was 2.9, compared with 9.7 in the MTX-alone group and 8.7 in the Humira-alone group.

Premier was a randomized, double-blind study conducted for two years, followed by a three-year, open-label extension. The Premier study evaluated the ability of Humira to inhibit radiographic progression for up to five years in patients with moderate to severe early RA. In the two-year, blinded portion of Premier, 799 patients received either a combination of Humira and MTX, Humira alone, or MTX alone.

A total of 354 patients completed five years of therapy and had x-rays available for evaluation. Of these, 124 initially received Humira and MTX, 115 received MTX alone, and 115 received Humira alone during the two-year, blinded portion of the Premier trial.

X-rays were evaluated to determine the progression of joint damage as measured by the change in mTSS from baseline. No further joint damage was defined as an mTSS increase of no more than 0.5.