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| |  Half of Patients Remain in Remission From Crohn’s Disease After 3 Years of Treatment With Adalimumab: Presented at CDDW By Cameron Johnston TORONTO -- March 4, 2010 -- Approximately half of the patients who initially responded to adalimumab therapy for the treatment of moderate to severe Crohn’s disease remained in remission for up to 3 years, according to a trial investigating the long-term use of the drug. In a poster session presented here on February 28 at the Canadian Digestive Diseases Week 2010 (CDDW), Remo Panaccione, MD, Inflammatory Bowel Disease Clinic, University of Calgary, Calgary, Alberta, presented the results of a 3-year extension trial of patients treated with adalimumab. The early efficacy of adalimumab was seen in a phase 3, double-blind, 56-week trial in which patients received the drug at baseline (80 mg) and at week 2 (40 mg), then were randomised to receive the drug every week, every other week, or a placebo for the next 52 weeks. At the end of the 56 weeks, patients were offered adalimumab 40 mg every other week, or every week when there were flares of the disease. According to Dr. Panaccione, 145 out of the 854 patients from the initial phase 3 trial were in remission at the start of the extension study, and 120 (83%) were still in remission 2 years later. Even using a more stringent method for analysing the data known as the “nonresponder imputation” 64% of the patients (93 out of 145) were still in remission after 3 years. There were remarkably few fluctuations in remission rates over the course of both the initial study and the extension study. While 47% of patients were in remission at week 26 of the original study, 51% were in remission at the start of the extension study (ie, week 56) and 52% were still in remission at the 3-year mark. The study is ongoing so it is not known how long these results may last. Overall, patients in both the initial study and the extension study showed very favourable results from the treatments. Based on the Crohn’s Disease Activity Index (CDAI), the disease is considered to be quiescent or in remission with a score of 150 (out of a possible 600). Over the 2-year extension study, more than 80% of patients had reductions in their CDAI scores of >100 points based on last observation carried forward data. The percentage of patients who had reductions of >70 points in their CDAI scores was similar. As for adverse events, two-thirds of patients over the 3-year period had some degree of adverse event, and 30% were serious. Seventeen percent of patients (n = 232) discontinued the study due to serious adverse events. The most common adverse events were infections, of which 6% were serious, and injection-site pain, which was recorded in 61 patients (4.4%). None of these events was unexpected, as similar patterns had been seen in previous studies. Dr. Panaccione and concluded that adalimumab shows sustained efficacy in maintaining remission rates from Crohn’s disease throughout 3 years of follow-up therapy, and that the majority of patients who are in remission after 1 year of treatment, will remain in remission for up to 3 additional years. Funding for this study was provided by Abbott Laboratories. CDDW is the annual scientific conference of the Canadian Association of Gastroenterology (CAG) and the Canadian Association for the Study of the Liver (CASL).
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