P539 Assessment of VEdolizumab aNd Ustekinumab in Elderly patients with Crohn’s disease (CD): the IG-IBD AVENUE study

Abstract

Abstract Background Comparative data regarding ustekinumab (UST) and vedolizumab (VDZ) effectiveness and safety in elderly inflammatory bowel disease (IBD) patients are limited. The aim of the present nationwide multicenter cohort study was to compare persistence and safety of these drugs in elderly versus non-elderly Italian IBD patients. Methods Data from 20 Italian centers were retrospectively collected. Based upon age and treatment, IBD patients aged ≥65 years were allocated to group 1 (G1) and group 3 (G3) (cases) if treated with UST or VDZ, respectively, and to group 2 (G2) and 4 (G4) (controls) if they were aged < 65 years and treated with UST or VDZ, respectively. The primary outcome was drug persistence at week 52. Propensity score analysis was performed for primary outcome using the inverse probability of treatment weighting method. Secondary outcomes included: steroid free remission (SFR) at week 52 and frequency of adverse events (AEs) at the end of follow-up. Results A total of 439 patients (176 elderly and 260 non-elderly) were included in the study. Among elderly patients, 93 and 83 were included in the group G1 and G3, respectively. Among non-elderly patients, 147 and 116 were included in the group G2 and G4, respectively. Baseline characteristics are represented in Table 1. No differences were found in terms of persistence between G1 vs G3, G1 vs G2 and G3 vs G4 (Figure 1). Higher baseline Harvey-Bradshaw Index (HBI) (OR=2.09, 1.15 – 3.78; 0.015) and baseline steroid therapy (OR=1.10, 1.04 – 1.15; p<0.001) were identified as predictors of a lower drug persistence at Cox model. Steroid free remission at week 52 was achieved by 80% and 77% of elderly patients in G1 and in G3 (p=0.63), respectively. Similarly, no differences for SFR were found between G1 and G2 (p=0.73) and between G3 and G4 (p=0.68). Incidence rate for AEs were G1 and G2 were 7.85 and 7.90 respectively; for G3 and G4 IR were 5.81 and 12.50 respectively. No differences were found in the UST groups (IRR=0.99; p=0.98) while in VDZ-treated patients, non-elderly had a higher rate of AEs (IRR=0.46; p=0.006). Conclusion These data confirm that ustekinumab and vedolizumab are highly effective drugs in patients with IBD, associated with a good safety profile in both elderly and in non-elderly IBD patients.