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

Abstract

ABSTRACT-Infliximab is a biological agent that is licensed for the treatment of severe Crohn's disease. The annual cost of infliximab treatment is approximately £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.

Systematic review: factors associated with relapse of inflammatory bowel disease after discontinuation of anti‐TNF therapy

“…If a patient is in clinical remission – as confirmed by clinical features, biological markers, or endoscopic or radiological studies – NICE recommends that treatment with biological agents be withdrawn, although the patient should continue to take either thiopurines or methotrexate. Of note, this conclusion was based on uncontrolled data from an abstract and a small retrospective case series …”

“…Some authors have assessed the impact of the NICE guidelines on patient care by prospectively auditing patients who had been receiving IFX for 12 months or more . The audit provided the opportunity for full reassessment of disease and, for patients who were in clinical remission, the option to stop treatment.…”

Reassessment of Crohn's disease treated with at least 12 months of anti-TNF therapy: how likely is treatment withdrawal?

“…Despite the reassuring data regarding successful retreatment in patients withdrawn from anti-TNF therapy, risk of relapse is often a contraindication to trial of withdrawal particularly for personal reasons such as work, education or a desire to become pregnant 11. It is perhaps, therefore, unsurprising that some patients have concerns regarding withdrawal of anti-TNF therapy 16 17…”

The impact of updated NICE guidelines on biologic treatment of ulcerative colitis: reflections on past practices, the changing present and implications for the future

“…Indeed, a retrospective UK-wide study explored the outcome of anti-TNF withdrawal in inflammatory bowel disease and found that 35% of UC patients had relapsed within a year of cessation. [15] In addition, treatment withdrawal may not be the preferred option for many patients [16] or clinicians.…”