Characterization and Impact of Risankizumab on patients with Fistulizing Crohn’s Disease in the Real World: Findings from TARGET-GASTRO.

Challenge

Fistulizing Crohn's disease is among the most difficult-to-treat phenotypes, with high rates of surgery and poor long-term outcomes. Real-world data characterizing the patient profile and clinical impact of risankizumab specifically in fistulizing CD patients—separate from the broader luminal CD population studied in registration trials—were absent.

Solution

The TARGET-IBD registry was used to identify fistulizing CD patients initiating risankizumab and characterize their baseline demographics, disease history, and longitudinal outcomes including fistula response, endoscopic findings, and treatment modifications in real-world US clinical practice.

Impact

Establishing the real-world effectiveness and patient profile of risankizumab in fistulizing CD provides AbbVie with post-authorization effectiveness evidence for this high-need subgroup, supporting label communications, payer negotiations, and prescriber guidance for risankizumab in a population underrepresented in pivotal trials.