my personal edition > ibd > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Adalimumab Effective in Active Crohn's Disease: Presented at DDW

By Crystal Phend

LOS ANGELES, C.A. -- May 29, 2006 -- Adalimumab appears effective in inducing and maintaining clinical response and remission of active Crohn's disease symptoms, researchers said here at Digestive Diseases Week 2006 (DDW).

Weekly or bimonthly adalimumab can maintain these effects without the use of steroids as well as closure of fistulas in patients with moderately to severely active Crohn's disease, said lead author Jean-Frederic Colombel, MD, researcher, Centre Hospitalier Universitaire de Lille, Lille, France.

Adalimumab is a fully human antitumor necrosis factor (TNF) monoclonal antibody approved for the treatment of rheumatoid arthritis and psoriatic arthritis. Other studies have demonstrated its efficacy in inducing remission of Crohn's disease.

This double-blind, placebo-controlled, multicenter study evaluated maintenance therapy with 40 mg of adalimumab every 2 weeks or once weekly over 56 weeks. Patients who responded to an open-label induction phase were included in the trial. Of 778 patients randomized to receive adalimumab or placebo, 499 patients with a clinical response at week 4 were evaluated for response in this analysis.

The researchers defined remission as a score of < 150 on the Crohn's Disease Activity Index (CDAI).

The percentage of these patients in remission was significantly better at every study time point past baseline for patients who received the study drug compared with placebo.

At week 26, 47% of the weekly-dose group and 40% of the every-2-weeks group achieved remission compared with 17% of the placebo group, Dr. Colombel said in his presentation on May 23^rd.

At week 56, 41% and 36% of adalimumab patients, respectively, were in remission compared with 12% of the placebo group.

Steroid-free remission was also significantly superior for the 2 adalimumab groups compared with placebo. At week 26, the figures were 30%, 35%, and 3%, respectively, and at week 56 they were 23%, 29%, and 6%, respectively.

Complete healing of draining fistulas at the last 2 consecutive office visits was achieved in significantly more adalimumab patients than placebo (30%, 37%, 13%, respectively).

Adverse events were primarily mild to moderate in severity, according to the researchers, and the safety profile was consistent with previous studies of adalimumab.


[Presentation title: Adalimumab Induces and Maintains Clinical Response and Remission in Patients With Active Crohn's Disease: Results of the CHARM Trial. Abstract 686d]

E-Mail this DGDispatch to a colleague

To print, use this version