Adalimumab Shows Promise for Treatment of Crohn's Disease

May 19, 2005

Laura Gater

May 19, 2005 (Chicago) — Patients receiving adalimumab (Humira) for Crohn's disease showed a progressive increase in clinical response and clinical remission, according to results from a new phase 3 study presented here at the Digestive Disease Week 2005. One third of subjects were in remission at the end of six months. Adalimumab was safe and well-tolerated in this study.

Adalimumab is a fully human antitumor necrosis factor α monoclonal antibody that is structurally identical to naturally occurring human antibodies. Its efficacy was evaluated previously in the CLASSIC (Clinical Assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's) trial, a four-week, randomized, double-blind, placebo-controlled, multicenter study. Patients who completed this study were eligible to enroll in the CLASSIC II trial.

The trial included 220 patients who had participated in the original CLASSIC study but were not in remission at weeks 0 and 4 of CLASSIC II. The subjects were between ages 19 and 74 years, with a mean age of 37 years. Forty-eight percent were men, and 89.7% were white. Their mean Crohn's Disease Activity Index (CDAI) score was 246.1 points. It was a 260-week multicenter trial, with a 52-week randomized segment and an open-label treatment segment.

The standard dose for this cohort was open-label treatment with 40 mg of adalimumab every other week. Seventy-eight percent or nearly four of five patients who completed the adalimumab open-label treatment saw improvement in their disease, as measured by a decrease of more than 70 points from baseline in their CDAI score. Of the 220 patients enrolled in the trial, one in three achieved clinical remission, defined as CDAI less than 150 points.

Associated adverse events were mild to moderate in severity. The most common were exacerbations of Crohn's disease and infections. Of 194 patients who completed the trial, 88.2% had at least one adverse event. One patient had pneumonia and sepsis.

"This is uncontrolled data and the first trial involving adalimumab for Crohn's disease. This is the first hint that adalimumab might be an effective treatment strategy. The long-term administration of adalimumab seems well-tolerated in patients with Crohn's disease," William Sandborn, MD, one of the study investigators, told Medscape. "Phase 3 is now fully enrolled and will be completed later this year. Patients in phase 3 receive different doses of adalimumab vs placebo," Dr. Sandborn said.

Dr. Sandborn is a professor of medicine at the Mayo Medical School and a staff member in the division of gastroenterology and internal medicine at the Mayo Clinic in Rochester, Minnesota.

"CLASSIC II is only the first part of the study. The results so far are encouraging," Marc Lemann, MD, Paris, France, who moderated the session, told Medscape.

Paul Rutgeerts, one of the study authors, is a consultant for Abbott Laboratories, maker of adalimumab.

DDW 2005: Abstract 723. Presented May 18, 2005.

Reviewed by Gary D. Vogin, MD

Laura Gater is a freelance writer for Medscape.

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