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| |  ACG: Results of Infliximab as Maintenance Therapy in Treatment of Crohn’s Disease Presented By Cameron Johnston Special to DG News LAS VEGAS, NV -- October 22, 2001 -- Infliximab (Remicade, Centocor) used mainly in the treatment of rheumatoid arthritis, has been found useful in treating moderate and severe Crohn’s, including fistulizing Crohn’s disease over a period of at least one year. Speaking in a plenary scientific presentation today at the annual meeting of the American College of Gastroenterology, Dr. Stephen Hanauer of the University of Chicago Medical Center, in Chicago, Illinois, outlined the findings of the ACCENT-1 trial, showing that a carefully calibrated maintenance dose of Remicade is significantly more effective than either placebo, or a lower dose of the drug at treating moderate to severe Crohn’s disease. The patients were recruited from the responders in a previous study in which 573 patients received one 5 mg infusion. Those who responded by week 2 (n = 335) were then randomized to the newer study design and would receive either a placebo (Group I) or 5 mg infusions (Group II) at weeks 2, 6, 14, 22, 30, 38 and 46. And those in Group III who received 5 mg infusions for weeks 2 and 6, and then for weeks 14, 22, 30, 38 and 46 received 10 mg infusions. The final evaluation as to mucosal healing, remission, or relapse and quality of life score were done at 54 weeks. After 30 weeks of treatment, 27, 51 and 59 percent of the subject in Groups I, II and III, respectively, were considered treatment successes -- that is to say, they experienced a 25 percent reduction in their Crohn’s Disease Activity Score, as well as an absolute drop of 70 points in the same score. Also at 30 weeks, significantly more subjects in the maintenance group were considered to be in clinical remission. As for the longer term study results, Dr. Hanauer said that at the end of week 54, 38 percent of subjects in the high-dose (maintenance group) were still in remission, as compared with 28 percent in the group receiving 5 mg infusions and 14 per cent who received placebo (p=0.001). They also had a longer time until the drug effect wore off. Subjects receiving the higher dose scored a “marked improvement” at the end of 54 weeks on the Irritable Bowel Disease Questionnaire - a quality of life index used for patients with Crohn’s. Significant benefit was also seen in the maintenance therapy group in terms of corticosteroid use, with 32 percent of those in the maintenance dose group stopping all steroid use, as compared with 24 percent in the 5 mg infusion group and nine percent in the placebo group. "In other words, maintenance dosing allowed steroid withdrawal. But with maintenance of remission at the end of the year," Dr. Hanauer said. A further 31 percent of those in the maintenance therapy group showed significant mucosal healing at the 10-week mark, while none in the placebo group did. Safety and tolerability, however, were less impressive with the maintenance therapy dosing. Adverse events such as headache, upper respiratory tract infections, abdominal pain occurred in 20-30 percent of patients, which was not unexpected, Dr. Hanauer said. However, 25 percent developed Crohn’s related gastrointestinal (GI) events, and though there were no differences between the three treatment groups, 3.7 percent of the GI adverse events were considered serious. In addition, six patients developed cancer, and one developed tuberculosis while taking infliximab. The fact that tuberculosis (TB) is a side effect associated with infliximab use is a known phenomenon, Dr. Hanauer reported, with 84 cases of TB, and 14 deaths being reported in post-marketing surveillance studies since infliximab came to the markets. It’s worth noting, he said, that three-quarters of the cases of TB become apparent within the first three infusions, and that three quarters of the cases have occurred outside the US, despite the fact that the US accounts for 80 percent of all infliximab use worldwide to date. With that in mind, Dr. Hanauer suggested that tuberculin skin prick testing should be done before any new patients are started on infliximab.
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