DOP023 Predictors of clinical and endoscopic response with vedolizumab for the treatment of moderately-severely active ulcerative colitis: results from the US VICTORY consortium

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Abstract

Background: Vedolizumab (VDZ) is now widely used for moderately-severely active ulcerative colitis (UC). Quantifying outcomes and identifying predictors of response would be of clinical utility.

Methods: Through a multicentre collaboration (US VICTORY consortium), UC patients starting VDZ were pooled across 9 academic sites. The current analyses include patients with moderately-severely active disease (Mayo endoscopic sub-score 2 or 3) within 12 weeks prior to starting VDZ, and at least one follow-up. Response was based on the physician global assessment: clinically significant response defined as >50% reduction in symptom activity, and remission as complete resolution of all UC-related symptoms. Mucosal healing was defined as Mayo endoscopic sub-score of 0 or 1. Response to induction was assessed within 4 weeks of completing the 3rd dose of VDZ. Time-to-event and Cox proportional hazard analyses were used to quantify treatment outcomes and identify predictors of outcomes. Hazard ratios (HR) with 95% confidence intervals (CI) are presented; HR >1 indicates increased probability for achieving the outcome.

Results: The analysis included 180 UC patients (52% male; median follow-up, 9.4 months). Concomitant steroids alone (n=69, 38%), thiopurines alone (n=21, 12%), or both steroids and thiopurines (n=39, 22%) were used at baseline. Cumulative response, remission, and mucosal healing rates at 6 and 12 months are presented in Table 1.

On multivariable analyses, prior TNF-antagonist exposure was associated with a reduction in probability for achieving a significant clinical response (HR, 0.58; 95% CI, 0.39–0.86) and clinical remission (HR, 0.55; 95% CI, 0.35–0.88), but not steroid-free response (HR, 0.72; 95% CI, 0.38–1.37), steroid-free remission (HR, 0.63; 95% CI, 0.31–1.29), or mucosal healing (HR, 1.00; 95% CI, 0.56–1.80). Achieving a significant response to induction (HR 1.98, 95% CI 1.15–3.39) was associated with achieving mucosal healing.

Conclusions: A substantial proportion of UC patients can achieve clinical remission, steroid-free remission, and mucosal healing by 12 months in routine practice. The magnitude of response was generally higher in anti-TNF-naive patients than anti-TNF experienced patients, and varied by the number of TNF-antagonists previously used. Response to induction therapy was associated with subsequent mucosal healing in VDZ patients.

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