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P120 Prevalence of endoscopic improvement and endoscopic remission according to patient reported outcomes in ulcerative colitis

P. Dulai1, S. Singh1, V. Jairath2, C. Ma3, N. Narula4, N. Vande Casteele1, L. Peyrin-Biroulet5, S. Vermeire6, G. D’Haens7, B. Feagan2, W. Sandborn1

1University of California San Diego, Gastroenterology, San Diego, USA, 2University of Western Ontario, Gastroenterology, London, Ontario, Canada, 3University of Calgary, Gastroenterology, Calgary, Alberta, Canada, 4McMaster University, Gastroenterology, Hamilton, Ontario, Canada, 5Nancy University Hospital, Gastroenterology, Nancy, France, 6University Hospitals Leuven, Gastroenterology, Leuven, Belgium, 7Academic Medical Center, Gastroenterology, Antilles, Amsterdam, The Netherlands

Background

We aimed to quantify the prevalence of endoscopic improvement (EI) and remission (ER) amongst ulcerative colitis patients with various permutations of patient reported outcomes (PRO) following treatment with biologic agents or tofacitinib.

Methods

Individual participant data from active intervention and placebo arms of clinical trials of infliximab, golimumab, vedolizumab, and tofacitinib were pooled to estimate the prevalence of EI (Mayo endoscopic sub-score [MES] 0 or 1) and ER (MES 0) scores with various permutations of the rectal bleeding sub-score (RBS) and stool frequency sub-score (SFS) of the Mayo score, following induction (6–8 weeks) and maintenance (30–54 weeks) therapy. Subgroup analyses were performed by year of publication and centrally read endoscopy scoring.

Results

Data from 2586 trial participants were analysed. Using locally scored endoscopy, the prevalence of EI and ER was highest among participants with a RBS 0 + SFS 0 post induction (EI: 81%, [95% CI 78–84]; ER: 29% [26–33]) and during maintenance (EI: 91% [87–93]; ER: 57% [52–62]). Prevalence estimates were lower for more recently performed trials (p < 0.01). In comparison to locally scored endoscopy, when using central endoscopy scoring the prevalence of EI and ER were lower post-induction (EI 57% [50–64], p < 0.001; ER 15% [11–21], p = 0.09) and during maintenance (EI 74% [67–81], p = 0.001; ER 31% [24–38], p = 0.001) for participants achieving a RBS 0 + SFS 0.

Conclusion

Approximately eight out of 10 patients with normalisation of rectal bleeding and stool frequency have improvement in endoscopic disease activity, whereas approximately only half of these patients have endoscopic remission.