Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

Exclusion Criteria

• •Participant unable to consent for themselves
• •Indication for immediate surgery (acute abdomen, perforation of the bowel, haemorrhage)
• •Crohn's disease
• •Participants with enteric infection confirmed on stool microscopy, culture or toxin
• •Haemodynamic instability (mean arterial pressure \<60) and not responsive to fluids
• •Participants with clinically significant Cytomegalovirus infection (positive inclusion bodies, immunohistochemistry and signs of viraemia such as fever and abnormal liver function tests)
• •Participants who are pregnant or currently breast-feeding
• •Participants with current malignancy, excluding basal cell carcinoma
• •Participants with flat low or high grade colonic dysplasia; sporadic adenomas permitted
• •Participants with serious co-morbidities including: Immunodeficiency; Myocardial infarction or acute stroke within the last 3 months; Moderate or severe heart failure (New York Heart Association class III or IV); Active or suspected tuberculosis; Renal failure; Hepatic failure; other severe infections
• •Participants with history of hypersensitivity to infliximab or infliximab biosimilar
• •Participants who have received other immunosuppressive agents including but not limited to: Anti-TNF therapies within 3 months of screening (Infliximab, Infliximab biosimilar, Golimumab, Etanercept, Certolizumab or Adalimumab); Anti-integrins (Vedolizumb, Etrolizumab) within 4 months of screening; Calcineurin inhibitors (Cyclosporine, Tacrolimus) within 4 weeks of screening; T or B cell depleters (Rituximab, Alemtuzumab) within 12 months of screening; other investigational agents (eg. Ustekinumab) within 6 months of screening