Definitions

a. AbbVie defines control as endoscopic responseb and clinical remission.^c

b. Endoscopic response: greater than 50% decrease in SES-CD from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease.^1,2

c. Clinical remission (SF/APS): average daily SF ≤2.8 and not worse than baseline and average daily AP score ≤1 and not worse than baseline.^1,2

d. Clinical response: ≥30% decrease in SF and/or ≥30% decrease in APS and both not worse than baseline.¹

e. Endoscopic remission: SES-CD of ≤4 and at least 2 points lower than at baseline and no subscore of any single variable >1. Re-randomization of clinical responders after induction.^1,3

f. Enhanced clinical response (SF/APS)*: ≥60% decrease in average daily SF and/or ≥35% decrease in average daily AP score and both not worse than baseline, and/or clinical remission.¹

g. NRI-C: non-responder imputation COVID-19, incorporating multiple imputation for missing data due to COVID-19 infection or logistical restrictions used for categorical endpoints; patients with missing data for all other reasons were counted as non-responders. In FORTIFY, patients who recieved rescue therapy were considered as non-responders for categorical endpoints.^2,3