Ustekinumab and Vedolizumab Are Equally Safe and Effective in Elderly Crohn’s Disease Patients

Abstract

Background Anti-tumour necrosis factor (anti-TNF) agents are associated with increased infection risk among elderly inflammatory bowel disease (IBD) patients, and thus, alternative biologics may be preferable. However, little comparative data exist on the safety and efficacy of vedolizumab and ustekinumab in elderly IBD patients. Aims To compare the safety and effectiveness of ustekinumab and vedolizumab in elderly Crohn’s disease patients. Methods Patients ≥ 60 years old who commenced ustekinumab or vedolizumab for Crohn’s disease (CD) were included. Primary outcome was serious infections, defined as requiring hospitalisation. Efficacy was assessed by treatment persistence and clinical response rates. We appropriately adjusted for confounders using propensity score-matched analysis weighted by the inverse predicted probability of treatment weighing and performed a logistic regression analysis to assess factors associated with serious infections and treatment persistence. Results Eighty-three patients commencing ustekinumab and 42 commencing vedolizumab therapy were included. In a propensity adjusted cohort, the rate of serious infection and treatment persistence were comparable between ustekinumab and vedolizumab. There was a significant reduction in HBI at 6 and 12 months compared to baseline in both groups. Male gender was positively associated with serious infection risk at 12 months, and penetrating disease behaviour was positively associated with 12-month treatment persistence. Baseline HBI score was negatively associated with 12-month treatment persistence. Cox regression analysis showed no overall difference in treatment discontinuation-free and serious infection-free survival by 12 months. Conclusions We observed comparable safety and effectiveness for ustekinumab and vedolizumab in treating elderly CD patients. Supplementary Information The online version contains supplementary material available at 10.1007/s10620-022-07770-8.

Efficacy and Safety of Biological Therapies and JAK Inhibitors in Older Patients with Inflammatory Bowel Disease

“…In a propensity score-matched analysis, a similar effectiveness of USTE versus VEDO was reported in older CD patients with a comparable CCI score [ 47 ]. Finally, the largest elderly CD cohort with a prolonged follow-up came from the ENEIDA registry and compared elderly with matched younger patients according to prior anti-TNF treatment and smoking habits.…”

“…Safety: Generally, the safety profile of USTE seems good and, in the smaller studies, serious infections were associated with concurrent steroid use but not with CCI [ 46 ]. In the aforementioned comparison study with USTE/VEDO, a similar rate of infections was reported for the two study drugs, and concomitant steroids were present in 20–25% of patients [ 47 ]. In this study, only on univariate analysis was CCI associated with serious infections.…”

“…Data are expressed as percentages according to different outcomes. SFR = steroid-free remission, SFP = steroid-free persistence, FU = follow-up, MH = mucosal healing, naïve: Patients without prior biologic treatment, studies including a younger control group of patients treated with the same biologic drug are represented with parallel bars, studies comparing different therapeutic drugs are allocated to the respective column, Ref [ 36 ] was excluded because only treatment failure was calculated [ 30 , 31 , 32 , 33 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 ].…”

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

“…Among the 63 publications, 10‐72 58 were journal articles and 5 were international conference abstracts. Two conference abstracts 71,72 were replaced by subsequent published articles found in our search.…”

IBD in the elderly - beware of pitfalls!

“…We recently reported comparable safety and effectiveness between vedolizumab and ustekinumab in an elderly cohort. [ 19 ] Some of the discrepant findings could be related to population differences across the studies. In particular, frailty has recently emerged as a significant predictor of adverse outcomes in IBD patients.…”