Abstract
BackgroundAdalimumab is effective in the treatment of Crohn's disease. We have already reported data on the efficacy of adalimumab in 110 steroid-dependent patients. At the end of the study 90 patients (64.5%) maintained clinical remission. AimsTo assess efficacy and safety of adalimumab after 6 years in patients of the original cohort who responded to treatment. MethodsThe present study is an extension of the published paper on 90/110 patients. We report results on clinical remission and safety of 6 year maintenance therapy with adalimumab. ResultsOf the original cohort 90 patients completed the study, 17 were lost to follow-up and 3 died. At the end of follow-up (74.16±10.3 months) 37/90 patients (41%) maintained clinical remission. Of these, 32 (86%) continued adalimumab and 5 (13%) discontinued treatment due to clinical remission and mucosal healing. Of the remaining 53/90 patients, 47 (52%) discontinued adalimumab due to clinical failure and 6 (7%) to adverse events.We obtained endoscopy data in 31/32 patients in clinical remission continuing adalimumab: 11 (36%) did not improve, 6 (19%) worsened, 14 (45%) improved. At univariable analysis no variables were related to treatment outcome. ConclusionsThis “real life” prospective study shows that adalimumab is a long-term effective and safe maintenance treatment in steroid-dependent Crohn's disease patients.
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