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Adalimumab demonstrates efficacy in Crohn's disease

Article

The human monoclonal antibody adalimumab induces significant Crohn's disease remission compared with placebo, according to trial results presented during Digestive Disease Week (DDW) in Chicago, Ill. Adalimumab is approved for the treatment of rheumatoid arthritis.

The human monoclonal antibody adalimumab induces significant Crohn's disease remission compared with placebo, according to trial results presented during Digestive Disease Week (DDW) in Chicago, Ill. Adalimumab is approved for the treatment of rheumatoid arthritis.

In an 8-week, phase 2 trial of 40 mg weekly adalimumab in 299 Crohn's disease patients, significantly more adalimumab-treated patients achieved remission defined as a Crohn's Disease Activity Index (CDAI) score of <150 compared with placebo patients.

A phase 3 trial followed and included 220 of these patients who had not achieved remission. They received 24 weeks of open-label adalimumab at 40 mg every other week, said William Sandborn, MD, professor of medicine, Mayo Clinic School of Medicine, Rochester, Minn. Study participants were evaluated at each study visit for remission and for clinical response of either 70- or 100-point CDAI reductions. Patients who did not respond or who experienced a disease flare had the dosage adjusted to 40 mg weekly.

"These data suggest that both doses will probably be effective and that a substantial number of Crohn's disease patients will benefit from every-other-week dosing," Dr Sandborn said.

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