P186 Impact of tofacitinib maintenance therapy on key Ulcerative Colitis patient-reported outcomes of fatigue, urgency, abdominal pain and sexual dysfunction using IBDQ and SF-36 individual items as proxies

Abstract Background Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). This novel analysis evaluated tofacitinib outcomes using items from Inflammatory Bowel Disease Questionnaire-32 (IBDQ) and Short Form-36 Health Survey (SF-36) as proxies key UC patient-reported (PROs) fatigue, urgency, abdominal pain sexual dysfunction over 52 weeks maintenance treatment. Methods Data 593 patients with in OCTAVE Sustain (NCT01458574) were included.1 PROs assessed via self-reported proxy each symptom/dysfunction interest IBDQ SF-36. A longitudinal mixed-effects model compared 5 10 mg twice daily (BID) vs placebo up to change baseline (CFB) predefined SF-36 item. Least squares (LS) mean differences standardised effect sizes (ES; LS difference divided by standard deviation [SD] item scores) calculated placebo; ES 0.1, 0.2, 0.5 0.8 trivial, small, medium large, respectively, categorisation intervals defined midpoints between these absolute values.2 means (LS mean/SD both doses at Week calculated. p<0.05 denoted statistical significance. Results At 52, all improved BID placebo, significant differences. Large reported fatigue urgency proxies; had (Figure 1). For items, except proxies, ‘Did you feel worn out?’ tired?’ (both BID). Small large 2). Regarding CFB, maintained responses 52. changes generally not tofacitinib; this was evident items. Trivial BID, placebo. Significant worsening observed interest. Conclusion Compared better reflected through ES. Responses therapy but worsened Proxy have been validated measure symptom 1. Sandborn WJ et al. N Engl J Med 2017;376:1723–1736. 2. Dubinsky MC Inflamm Dis 2021;27:983–993.