Vedolizumab (VDZ) is used to treat moderately-to-severely active Crohn's disease (CD) and ulcerative colitis (UC). Treatment algorithms have shifted toward integrating mucosal healing (MH) as a treatment target. Quantifying MH rates in clinical practice and identifying predictors of achieving MH with VDZ would be of clinical utility.Methods:
Institutional review board approval for data collection and data sharing were obtained to create the Vedolizumab for Health Outcomes in Inflammatory Bowel Disease (VICTORY) consortium. Patients from the consortium were included in the current analysis if they had moderately-severely active disease (based on endoscopy or clinical indices) prior to starting VDZ, and at least one endoscopic or radiographic follow-up to assess for MH. MH was defined as the absence of all ulcers and/or erosions for CD and a Mayo endoscopic sub-score of 0 or 1 for UC. Response to induction was defined according to the physician global assessment with at least a >25% reduction in symptom frequency or severity. Univariable and multivariable Cox proportional hazard analyses were used to assess the association of various factors with achieving MH, and were expressed as hazard ratios (HR) with 95% confidence intervals (CI), with HR >1 indicating increased probability for achieving MH.Results:
A total of 507 IBD patients (n = 293 CD, n = 214 UC) with moderately-to-severely active disease and a median follow-up of 270 days (interquartile range [IQR], 160–408) were included. A follow-up assessment for MH was available for 330 (CD, n = 199; UC, n = 131). Of these patients, 127 (CD, n = 81; UC, n = 46) were on concomitant immunomodulators, and 280 (CD, n = 188; UC, n = 92) had prior exposure to anti-TNF therapy, with 179 (CD, n = 147; UC, n = 32) having been exposed to 2 or more anti-TNF agents. Cumulative rates for MH at 6 and 12 months were 19% and 58% for CD, and 24% and 59% for UC, respectively. CD patients on concomitant immunomodulators (HR, 1.66; 95% CI, 1.00–2.74) and those achieving a clinical response to induction therapy as determined by the treating physician (HR, 2.01; 95% CI, 1.12–3.60) were more likely to achieve MH. UC patients achieving a response to induction therapy (HR, 7.48; 95% CI, 1.80–30.99) were more likely to achieve MH. The number of anti-TNF agents previously used for UC patients was associated with an incremental reduction in achieving MH (HR, 0.697; 95% CI, 0.49–0.96).Conclusions:
In this multi-center consortium, MH rates were similar for CD and UC, with cumulative rates of 58% and 59% at 12 months. Clinical response to VDZ induction was an independent predictor for achieving MH in both CD and UC. CD patients on concomitant immunomodulators were more likely to achieve MH, and UC patients with prior anti-TNF exposure were less likely to achieve MH.