Vedolizumab: Efficacy and Safety in Patients With IBD-Real World Experience in a Large Academic University Medical Center

Abstract

Introduction: Vedolizumab (α4β7 integrin Ab) (VDZ) is FDA approved for Crohn's disease (CD) and Ulcerative colitis (UC). Real world effectiveness & safety at tertiary care settings in populations who had previously failed anti-TNFs (TNFI) or combination therapy are incompletely understood. We assessed which factors are associated with rates of response (RES), remission (REM), and adverse events (AE) at a tertiary care medical center. Methods: Pts receiving >1 dose of VDZ via query of our EMR were identified. Pts who completed induction (3 doses) were eligible for inclusion. IBD phenotype, concurrent immunomodulators (IM) & steroids (CS), prior TNFI, & age at initiation of VDZ were assessed. RES is defined as ≥ 3 decrease in Harvey Bradshaw index (HBI) or Simple clinical colitis activity index (SCCAI) scores. REM is HBI score of ≤ 4 or SCCAI ≤2. Association btwn baseline characteristics & RES or REM was assessed via chi square test & univariable logistic regression. Results: 67 pts started VDZ; 38 completed induction (26 CD, 10 UC, 2 Indeterminate). 55% were male. 47% had prior GI surgery. Mean F/U from VDZ initiation was 27.9 wks. 4 (10%) patients were TNFI naive, 24% had 1 TNFI, 32% had 2 TNFIs, & 34% had 3 TNFIs. During VDZ start, 39% were on an IM & 50% of pts were on CS. At week 0 & 14, Median HBI scores & SCCAI were 8 & 5 and 8 & 4.5, respectively. 87% of pts w/ active disease during induction experienced a RES & 47% experienced REM. In univariable logistic regression, age, prior anti-TNF, prior surgery, IBD subtype, & concurrent IMs or CSs were not significantly associated with an increased RES or REM. One UC & 1CD pt stopped VDZ at 20 wks & 14 weeks due no response. Two pts decreased dosing interval to q 4 wks due to recurrent disease w/CS taper after 14 weeks. 4 pts acquired infections during VDZ treatment. 4 pts reported minor side effects. 1 pt with prior malignancy tolerated VDZ w/o recurrence. 4 pts were in REM at initiation of VDZ but were steroid dependent. 75% were able to decrease pred to 5mg. 1 pt was in REM on adalimumab but switched to VDZ 2/2 psoriasis & kept REM. Conclusion: In this tertiary center experience, where the majority of IBD pts have complex disease & have been refractory to 2 or more TNFI (66%), VDZ is a safe, well tolerated medication with equal efficacy in UC & CD. RES and REM rates were not associated with age, concurrent CS or IM use, or prior GI surgery.Table 1: Baseline Patient CharacteristicsTable 2: Vedolizumab Response, Remission, Adverse Event, and Infection Rates