Table 1

IBD-RESPONSE key clinical definitions

Clinically active disease	CD: unweighted PRO-2 (CD) of average daily SF subscore ≥4 and/or average daily AP subscore ≥2. UC: total PRO-2 (UC) ≥3 with RB subscore ≥1. PRO-2 data will be entered by patients over 4 days (minimum 2 days PRO-2 data are permissible for PRO-2 calculation).
Clinical remission	Patient remains on drug and meets the following criteria: CD: unweighted PRO-2 (CD) average daily SF subscore ≤2.8 and average daily AP subscore ≤1 (and neither worse than inclusion scores at baseline). UC: PRO-2 (UC) SF subscore ≤1 with a decrease of ≥1 point(s) in SF subscore from baseline, plus RB subscore=0. AND an absence of any of the following at time of assessment: Resectional bowel surgery at any time after baseline until time of current assessment. Current use of oral corticosteroids/failure to wean oral corticosteroids prescribed at baseline.
Clinical response	Meeting criteria for clinical remission OR: CD: unweighted PRO-2 (CD) ≥30% reduction in average daily SF subscore and/or ≥30% decrease in average daily AP subscore (and neither worse than inclusion scores at baseline). UC: total PRO-2 (UC) decrease ≥1 and ≥30% from baseline, and a decrease in RB subscore ≥1 or an absolute RB subscore of ≤1. AND an absence of any of the following at time of assessment: Resectional bowel surgery at any time after baseline until time of current assessment. Current use of oral corticosteroids/failure to wean oral corticosteroids prescribed at baseline.
Week 14 non-response	Not meeting clinical response criteria AND not having stopped drug for any reason other than lack of efficacy.
Week 54 loss of response	Not meeting clinical response criteria at week 54 having met clinical response criteria at week 14 (AND not having stopped drug for any reason other than inefficacy between week 14 and week 54 assessments).

AP, abdominal pain; CD, Crohn’s disease; PRO, patient-reported outcome; RB, rectal bleeding; SF, stool frequency; UC, ulcerative colitis.