A prospective study of infliximab withdrawal after 12 months of treatment in patients with Crohn's disease: how will NICE guidance affect patient care?

Infliximab is a biological agent that is licensed for the treatment of severe Crohn's disease. The annual cost of infliximab treatment is approximately pound 16,456 (excl VAT). In May 2010, the National Institute for Health and Clinical Excellence (NICE) recommended that patients should receive biological agents as a planned course of treatment only until treatment failure or until 12 months after the start of treatment, whichever is shorter. Patients should then have their disease reassessed to determine whether they still have active disease and whether ongoing therapy is still appropriate. We assessed the impact of the new NICE guidance on patient care by prospectively auditing patients who had been receiving infliximab for 12 months or more. The audit provided the opportunity for full disease reassessment and, for patients who were in clinical remission, the option to stop treatment. Disease was reassessed in 21 patients; a further 13 patients refused consent. Four patients were in deep clinical remission and discontinued infliximab. Implementation of the NICE recommendations on the use of infliximab in Crohn's disease is likely to be challenging in the face of significant resistance from patients who have an understandable fear of relapse. It might be more appropriate to discuss treatment withdrawal when high-quality evidence is available to support this management option.