P23 Comparative safety and effectiveness of ustekinumab and vedolizumab in elderly crohn’s disease patients

Abstract

<h3>Background</h3> Anti-TNF agents are effective in treating elderly Crohn’s disease (CD) patients but its use is limited by increased risk of infections and treatment discontinuation. Evidence for safety and efficacy of non-anti-TNF biologics in the elderly is limited. We aimed to compare the safety and effectiveness of ustekinumab and vedolizumab in elderly CD patients. <h3>Methods</h3> We conducted a retrospective multi-centre cohort study which included CD patients ≥ 60 years old on ustekinumab (n=70) or vedolizumab (n=28). Nearest neighbour propensity score matching was used to identify matched participants. We used logistic regression analysis to assess the association between treatment group and covariates to estimate propensity scores. The primary outcome was severe infection defined as requiring hospitalisation and secondary outcomes were effectiveness and non-severe infection. Effectiveness was assessed using serial HBI scores, treatment persistence (TP) and steroid-free TP. Wilcoxon signed-rank test was used to assess significance. <h3>Results</h3> Propensity matching identified 24 patients from each group with matching characteristics (Table 1). 4 patients on ustekinumab (22.6/100 patient-years) and 3 patients on vedolizumab (15.6/100 patient-years) developed severe infection within 12 months of starting treatment (p=0.698) – by contrast, 12 non-severe infections were reported in 7 patients on vedolizumab compared to 7 cases in 6 patients on ustekinumab (p=0.586). There was no significant change in HBI score after 12 months of treatment with vedolizumab (p=0.113) whereas a significant decrease in HBI score was seen in patients on ustekinumab (p=4.12 x 10^-7). In both groups, 13 patients remained on treatment after 12 months (steroid free TP rates vedolizumab 100% vs ustekinumab 92%). <h3>Conclusion</h3> There was no significant difference in the incidence of infection and TP rates in a propensity-matched cohort of elderly CD patients treated with vedolizumab or ustekinumab. There was a significant drop in HBI at 12 months for ustekinumab but not vedolizumab treated patients.