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Prevalence of endoscopic improvement and remission according to patient‐reported outcomes in ulcerative colitis
Author(s) -
Dulai Parambir S.,
Singh Siddharth,
Jairath Vipul,
Ma Christopher,
Narula Neeraj,
Vande Casteele Niels,
PeyrinBiroulet Laurent,
Vermeire Severine,
D’Haens Geert,
Feagan Brian G.,
Sandborn William J.
Publication year - 2020
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.15577
Subject(s) - medicine , ulcerative colitis , endoscopy , vedolizumab , golimumab , gastroenterology , placebo , clinical trial , infliximab , surgery , disease , pathology , alternative medicine
Summary Background Treatment targets for ulcerative colitis are evolving towards achievement of endoscopic improvement and remission in addition to symptom resolution. It remains to be accurately quantified what proportion of patients with symptom resolution have residual endoscopic activity that might warrant treatment modification. Aim To quantify the prevalence of endoscopic improvement and remission amongst ulcerative colitis patients with various permutations of patient‐reported outcomes. 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 endoscopic improvement (Mayo endoscopic sub‐score [MES] 0 or 1) and remission (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 endoscopic improvement and remission was highest among participants with a RBS 0 + SFS 0 post‐induction (MES 0/1:81%, [95% CI 78‐84]; MES 0:29% [26‐33]) and during maintenance (MES 0/1:91% [87‐93]; MES 0:57% [52‐62]). Prevalence estimates were lower for more recently performed trials ( P < .01). In comparison to locally scored endoscopy, when using central endoscopy scoring, the prevalence of endoscopic improvement and remission was lower post‐induction (MES 0/1 57% [50‐64], P < .001; MES 0 15% [11‐21], P = .09) and during maintenance (MES 0/1 74% [67‐81], P = .001; MES 0 31% [24‐38], P = .001) for participants achieving a RBS 0 + SFS 0. Conclusions Approximately 8 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.