SERum And Faecal INfliximab levels in Acute colitis (SERAFINA Study)
Research type
Research Study
Full title
SERum And Faecal INfliximab levels in Acute colitis (SERAFINA Study)
IRAS ID
254357
Contact name
John Paul Seenan
Contact email
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Ulcerative colitis is an inflammatory bowel disease (IBD). It is a chronic condition but can present suddenly or flare unexpectedly as acute severe ulcerative colitis (ASUC) with bloody diarrhoea, fevers, weight loss and poor appetite. Historically, 1/3 of ASUC patients will require surgery to remove their large bowel (colectomy) due to failure of medical therapy.
Infliximab, which blocks the pro-inflammatory tumour necrosis factor-alpha (TNFα), is used both as rescue medical therapy for patients with ASUC (where it avoids colectomy in 60-70%) and as maintenance therapy in outpatients refractory or intolerant to conventional treatments (i.e. aminosalicylates, steroids or thiopurines). Higher IFX drug levels predict treatment response when used regularly but limited data exists on the role of therapeutic drug monitoring (TDM) in ASUC where a greater inflammatory burden and higher drug losses due to increased gut permeability may influence pharmacokinetics.
Microbial composition has also been suggested to have a role in predicting treatment failure in paediatric UC (Michail et al Inflammatory Bowel Disease 2013) but its utility in adults is largely unknown.
By comparing inpatients with ASUC and an outpatient control group starting IFX for UC this pilot study will examine the relationship between early IFX drug levels, stool losses and inflammation. It will also explore how stool microbial composition may influence early IFX levels and whether these factors predict treatment response and/or need for colectomy.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0168
Date of REC Opinion
22 Jul 2019
REC opinion
Further Information Favourable Opinion