Switching from Dose-Intensified intravenous to SubCutaneoUS infliximab in Inflammatory Bowel Disease: a randomised controlled trial - DISCUS-IBD

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Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, is an incurable, chronic illness. Patients with IBD often require long term immune suppressing medications. Infliximab is a biologic medication that achieves and maintains remission in the majority of IBD patients. However, between 30 and 50% of patients require higher doses of infliximab than that which is registered in Australia. Infliximab is traditionally administered intravenously (IV). However, a new infliximab formulation administered directly beneath the skin (subcutaneous tissue), appears to be equally effective to IV infliximab. Subcutaneous medications are preferred by the majority of patients given greater flexibility and convenience. Emerging evidence demonstrates that, in patients receiving dose-intensified IV infliximab, switching to subcutaneous infliximab maintains remission in the vast majority of patients. This study aims to confirm that patients with Crohn’s disease and ulcerative colitis receiving dose-intensified IV infliximab can switch to subcutaneous infliximab and maintain clinical and biochemical (blood and stool test) remission and adequate drug levels. We will perform a multicentre, randomised non-inferiority trial. We will recruit 120 adults with IBD in remission receiving stable dose-intensified IV infliximab. Participants will be randomly allocated to continue their current regimen or to switch to subcutaneous infliximab. Clinical and biochemical activity as well as drug levels will be measured every 12 weeks until study conclusion at week 48. The primary outcome is rate of relapse between the two groups at week 48. Relapse is defined as composite clinical and objective activity OR need for corticosteroids, immunomodulator or switch in therapy OR need for IBD-related hospitalisation/surgery. Patients meeting the first clinical and biochemical relapse criterion are permitted one dose-escalation in their subcutaneous or IV infliximab. They will be recorded as meeting the primary endpoint whilst still remaining in the study to 48 weeks to measure response to further dose-intensification. Secondary endpoints will include changes in infliximab drug levels, anti-infliximab antibodies, economic impact, patient satisfaction and the change in clinical and biochemical markers of disease activity throughout the study.