Adalimumab useful in Crohn's disease maintenance therapy

Lead investigator Dr. William J. Sandborn told Reuters Health, "We demonstrated that adalimumab at doses of both 40 mg every other week and 40 mg weekly is more effective than placebo for maintaining remission in patients who initially entered remission after induction therapy with adalimumab. Adalimumab was well tolerated."

Dr. Sandborn of the Mayo Clinic in Rochester, Minnesota, and colleagues report that in the previously reported CLASSIC I trial, 299 patients naive to TNF-antagonist therapy received induction therapy with adalimumab at doses of up to 80 mg per week at baseline and at week 2.

The 55 patients who were in remission after week 4 in the CLASSIC I trial were entered into the CLASSIC II trial and randomly assigned to every other week or weekly adalimumab 40 mg or to placebo (n = 19, 18, 18, respectively).

Based on Clinical Disease Activity Index (CDAI) scores at week 56, remission rates were 79% in the group treated every other week, 83% in those treated weekly, and 44% in the placebo group (p < 0.05 for each adalimumab group versus placebo).

IBDQ scores (Inflammatory Bowel Disease Questionnaire, scores range from 32 to 224) were used to assess function and quality of life; scores of 170 or higher correspond to clinical remission.

Mean baseline IBDQ scores exceeded 170 in all three groups, which were sustained throughout the 56 weeks of active treatment. In contrast, scores declined rapidly in the placebo group, with no mean scores above 170 after week 20.

The 204 patients who did not achieve remission after week 4 of CLASSIC 1 were treated with open-label adalimumab; among these 131 (64%) completed the 56-week trial.

At the end of the trial, 93 (46%) of the open label group were in clinical remission.

Given these findings, the researchers conclude that "adalimumab represents an important new therapeutic option for the treatment of Crohn's disease."