Abstract
Abstract Background Early disease control, which includes symptom remission with mucosal healing (endoscopic and histological remission) is emerging as a potential therapeutic goal in ulcerative colitis, which may be achieved by effective therapeutic intervention.1 This post-hoc analysis examined the impact of achieving individual symptom resolution, endoscopic improvement (EI) or endoscopic remission (ER) post 12 Weeks (Wk) of risankizumab (RZB; a specific inhibitor of interleukin-23) induction treatment on achieving long-term clinical, endoscopic, and quality of life (QoL) outcomes at maintenance Wk 52. Methods This analysis included patients (pts) who achieved a clinical response after 12 wks of intravenous RZB in Phase 2b and Phase 3 INSPIRE induction studies and received subcutaneous RZB 180 or 360 mg in COMMAND maintenance study. The frequency and proportions of pts achieving maintenance Wk 52 outcomes (clinical remission [CR], EI, ER, or meaningful change in QoL) between pts who achieved the absence of symptoms (abdominal pain, bowel urgency [BU], tenesmus, fecal incontinence [FI], sleep interruption [SI], nocturnal bowel movements [NBM]), achieved fatigue normalization, or achieved EI/ER at end of induction vs those who did not was determined. Adjusted predictive analyses assessed the relationship between achieving outcomes at induction Wk 12 and maintenance Wk 52, reported as logistic regression-derived odds ratios (ORs) and 95% confidence intervals. Results In total, 179 and 186 pts received RZB 180 and 360 mg during maintenance, respectively. After adjusting for pt characteristics, pts who achieved absence of symptoms at Wk 12 had significantly greater odds of achieving CR, EI, or ER at Wk 52; specifically, absence of BU, FI, and NBM were significantly associated with CR (OR 1.793, 1.722, 1.645), absence of BU and NBM were significantly associated with EI (OR 1.557, 1.563), and absence of FI, NBM, and SI were significantly associated with ER (OR 2.337, 2.318, 2.355). Similarly, pts who achieved endoscopic outcomes of EI/ER at induction Wk 12 had a significantly greater odds of achieving CR (OR 2.011/3.332) and maintaining EI (OR 2.278/5.974) and ER (OR 3.222/7.426) at Wk 52 (Figure). Pts achieving absence of BU, tenesmus, NBM, and ER at Wk 12 had significantly greater odds of achieving meaningful within-person change in QoL outcomes such as work time missed, impairment while working, and overall work and activity impairment at Wk 52 (Table). Conclusion Achieving early disease control with RZB treatment through symptom and specifically endoscopic outcome improvements at Wk 12 was generally associated with greater odds of achieving improved long-term clinical, endoscopic, and QoL outcomes at Wk 52.
Published Version
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