Abstract
Aim: To evaluate the real-world safety and effectiveness of risankizumab in patients with inflammatory bowel disease (IBD), using clinical outcomes and faecal calprotectin (FCP) as markers of response.
Methods: A retrospective observational study was conducted at East Lancashire Hospitals NHS Trust. Patients with a confirmed diagnosis of IBD who were initiated on risankizumab were included. Clinical outcomes, FCP levels, and treatment tolerability were assessed. As FCP values were non-normally distributed (Shapiro–Wilk p < 0.05), the Wilcoxon signed-rank test was used to compare pre-and post-treatment values.
Results: Thirty-two patients who were started on risankizumab treatment were analysed. Paired FCP data were available for 14 patients. Median FCP levels decreased from 1368.5 µg/g (range 146–2100) before treatment to 368 µg/g (range 52–2100) after treatment. The Wilcoxon signed-rank test demonstrated a statistically significant reduction in FCP following risankizumab therapy (Z=–2.201, p=0.028). Overall, 87.5% of patients reported clinical improvement and continued treatment. No adverse effects were reported while on therapy.
Conclusions: From this study, we conclude that risankizumab appears to be an effective and well-tolerated treatment option for patients with IBD.
Keywords
Risankizumab, Inflammatory bowel disease, Crohn’s disease, Ulcerative colitis, Biologic therapy, Real-world study, Monoclonal antibody, Gastroenterology