Method: Multi-centre retrospective cohort analysis of medical records
Cohort: Patients on JAKi (filgotinib and tofacitinib) for the treatment of UC
Inclusion criteria:
- Diagnosis of UC or IBDU favouring UC
- Symptoms attributed to active UC plus objective evidence of inflammation (CRP≥5, FC ≥250mcg/g, active inflammation on endoscopy / imaging)
- Minimum of 8-weeks follow up
Primary Outcome (week 8-12, week 26 and week 52):
- Rates of clinical remission (Partial Mayo <2 or SCCAI <5)
Secondary Outcomes (week 8-12, week 26 and week 52):
- Rates of biochemical remission (CRP <5 + FC <250mcg/g)
- Rates of mucosal healing (Endoscopic Mayo 0 or 1)
- Drug persistence
- IBD specific hospitalisation
- Colectomy rates
- Steroid use
- Rates of dose escalation (tofacitinib only)
- Safety and adverse events (inc. DVT, PE and malignancy)
- Predictors of effectiveness
- Comparative effectiveness between JAKi based on propensity score matching (if numbers allow)
Ethics: Caldicott approval will be required for data collection and dissemination. Scotland-wide approval will be applied for to avoid need for multiple site approvals.
Future work: The database can then be re-utilised for a second phase project to collect the same outcomes for upadacitinib which is now approved