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Adalimumab Effective for Crohn's Disease in 6-Month Open-Label Study

By W. A. Thomasson, PhD

CHICAGO, IL -- May 20, 2005 -- The efficacy of the fully human antitumor necrosis factor alpha (anti-TNF-alpha) adalimumab (Humera(R)) in Crohn's disease increases with continued administration, according to research presented here on May 16^th at Digestive Disease Week (DDW).

This study was a continuation of an earlier 4-week, double-blind trial, said William Sandborn, MD, professor of medicine and director, Inflammatory Bowel Disease Unit, Mayo Clinic and Medical School, Rochester, Minnesota.

Dr. Sandborn and colleagues enrolled patients who had remission of Crohn's disease after participating in an earlier 4-week, double-blind trial and/or after 4 weeks of open-label adalimumab treatment.

In the new study, patients received 40 mg adalimumab every other week, with dose escalation to 40 mg weekly being allowed for flare or persistent nonresponse. Some patients had previously received higher doses during the double-blind phase.

Dr. Sandborn presented data from evaluation at week 24, at which time about half of patients remained on alternate-week dosing, a quarter was on weekly dosing, and a quarter had dropped out. Clinical response was defined as a decrease of at least 70 points in the Crohn's Disease Activity Index (CDAI).

The proportion of patients with a clinical response increased steadily from 40.5% at week 0 (the end of the double-blind study) to 78.2% at week 24. Using the stricter criterion of a 100-point drop, the figures are 23.6% and 69.9%, respectively. By week 24, 33.2% of the patients were in remission, with a total CDAI of 150 or less.

Dr. Sandborn noted that adalimumab's fully human structure should largely eliminate immunogenicity concerns associated with other anti-TNF-alpha monoclonal antibody, such as infliximab, and might allow it to be used intermittently if that should prove desirable in some patients. Subcutaneous administration is likewise an advantage, he said.

The immunogenicity of infliximab is fairly well tolerated if the drug is administered properly, he said, adding that he has had minimal problems in a study of infliximab for ulcerative colitis that he conducted simultaneously to the current adalimumab trial.

These results illustrate the importance of long-term follow-up studies, he said, since they suggest the full benefits of adalimumab might not appear in short-term studies.


[Presentation title: Induction and Maintenance of Clinical Remission and Response in Subjects With Crohn's Disease Treated During a 6-Month Open-Label Period With Fully Human Anti-TNF-alpha Monoclonal Antibody Adalimumab (Humera(R)). Abstract 723]

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