Introduction
Ulcerative colitis, UC
INFLAMMATORY BOWEL DISEASE 1, DISEASE, CHRONIC INFLAMMATORY DISEASE, REMISSION, ULCERATIVE COLITIS
Ulcerative colitis (UC) is a chronic inflammatory disease associated with periods of relapse and remission that exerts a significant disease burden, affecting many patients worldwide [Treatment of UC traditionally follows a step-up approach and is dependent on the level of disease activity and extent of colonic involvement [Tofacitinib is an oral small-molecule JAK inhibitor for the treatment of UC. Tofacitinib treatment was shown to clinically and statistically significantly improve Mayo score-based outcomes, as well as Short Form-36 Health Survey (SF-36) and Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores, versus placebo, in two 8-week induction studies (OCTAVE Induction 1 and 2, NCT01465763 and NCT01458951) and a 52-week maintenance study (OCTAVE Sustain, NCT01458574) in patients with moderate to severe UC [It is unclear whether treatment effects on HRQoL are fully explained by changes in disease activity or if there are other mediators of treatment. Of note, evidence suggests that endoscopic targets may lack alignment with the clinical experience of the patient, as determined by instruments for the measurement of HRQoL [This post hoc analysis of data from OCTAVE Induction 1 and 2 explores the interrelationships among tofacitinib treatment, SF-36/IBDQ domains, and disease activity (as measured by Mayo subscores) using a mediation modeling framework [