DOP90 The association of endoscopic and histologic endpoints with faecal calprotectin and C-reactive protein in patients with moderately to severely active ulcerative colitis treated with mirikizumab

Abstract Background Mirikizumab [(miri), a p19-directed IL-23 antibody] has been shown to be effective in patients with moderately severely active ulcerative colitis (UC) Phase 3, randomised, double-blind, placebo-controlled trials (LUCENT-1 NCT03518086; LUCENT-2 NCT03524092).1 Given the importance of understanding treat-to-target strategies, relationship between improved histologic and endoscopic endpoints improvement inflammatory biomarkers faecal calprotectin (fCal) C-reactive protein (CRP) was studied within miri-treated enrolled programme. Methods This analysis focused on (n=868) from induction study receiving intravenous (IV) every 4 weeks (Q4W) until week (W)12 miri responders at W12, who were rerandomised for maintenance period, subcutaneous (n=365) Q4W up W52. The achieving histologic-endoscopic mucosal (HEMI), remission (HEMR) (definitions Tables) fCal (≤250µg/g) CRP (≤6mg/L) levels W12 W52 explored using Fisher’s exact tests. Results At significantly higher percentage HEMI (n=235/868) had normalised values (76.2% 88.5%), compared did not achieve (n=633/868) (21.8% 72.7%, both p<0.001; Table 1). Similarly, proportion HEMR (n=193/868) (79.3% 89.6%), those (n=675/868) (24.3% 73.3%, W52, responder (174/365) (74.1% 87.9%), (191/365) (32.5% 61.3%; p<0.001). (n=158/365) (76.6% 88.0%), versus (n=207/365) (33.8% 63.3%; p<0.001, 2). Conclusion treated achieved or showed statistically significant improvements levels. suggests that may useful markers histology endoscopy outcomes after miri. 1.Magro et al., MP245 Efficacy mirikizumab resolving inflammation Ulcerative Colitis Lucent-1 Lucent-2 (2022), UEG Week Moderated Posters. United European Gastroenterol J, 10: 185-472.