Switching patients from intravenous to subcutaneous infliximab in inflammatory bowel disease

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Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal system that mainly comprises ulcerative colitis (UC) and Crohn’s disease (CD). Treatment modalities include anti-tumour necrosis factor (TNF) biological agents such as intravenous (IV) infliximab infusions given regularly every 8 weeks, subcutaneous (SC) adalimumab given every 2 weeks and golimumab given every 4 weeks. Anti-TNF drugs are now available as biosimilars, which are identical copies of the originator drug. Remsima® is prescribed for adults 18 years or older at a dose of 120mg infliximab solution SC via pre-filled syringe or pen every 2 weeks. The efficacy of SC infliximab is similar to IV infliximab at one year in an initial open-label study. Another study demonstrated non-inferiority of SC infliximab compared with IV infliximab in terms of pharmacokinetic, efficacy and safety in patients with active Crohn’s disease and ulcerative colitis. Efficacy analysis found no statistically significant differences between both routes of administration. Safety profile was also comparable between both groups. The aim of our study is to determine whether SC infliximab is non-inferior to IV infliximab in the maintenance of clinical and biochemical remission in patients in IBD within Australia.. This study differs from prior studies as we will examine patients in remission (and not those with active disease). We also aim to determine the patient satisfaction of switching from IV infliximab to SC infliximab as determined by a self-administered questionnaire. The hypothesis of this study is that there is no difference in clinical outcomes between the two groups and that patients will be more satisfied with SC infliximab.