Randomized Controlled Trials in Active Luminal Crohn’s Disease

Fabiana      Castiglione; Antonio      Rispo

Abstract

Many trials focused on the treatment of active luminal Crohn’s disease (CD) have been published in literature. A critical reevaluation of the main trials regarding the use of 5-ASA derivates has shown a not significant benefit of such molecules in treating CD and, as a consequence, the European Crohn’s and Colitis Organization’s (ECCO) therapeutic statements highlight that 5-ASA should be considered clinically no more effective than placebo for active disease. The main evidence regarding the efficacy of conventional steroids as inductive therapy in active CD is still based on the old but fundamental Cooperative studies which can be considered at low risk for biases in spite of the date of publication. Most probably these RCTs will remain unsurpassed.

Current data do not support the use of antibiotics for active luminal CD as primary therapeutic strategy in view of very conflicting results. In accordance with these conclusions current guidelines dot not suggest this kind of treatment in active CD. Even if frequently used, data about the role of conventional immunosuppressors for the therapy of active luminal CD ara scanty. Azathioprine/6-MP should be no more considered as remission-inductive agents for active CD while methotrexate could be considered an effective therapeutic option in inducing remission in this setting particular setting. A number of clinical trials are available about the use of anti-TNF alpha agents (infliximab, adalimumab) in active luminal CD. Both drugs are surely effective in inducing remission even if safety and economic concerns should be better considered and investigated.

Keywords: Crohn, trials, biologics, immunosuppressors, antibiotics, IBD

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