Comparative safety and effectiveness of tumor necrosis factor α antagonists and vedolizumab in elderly IBD patients: a multicentre study

Abstract

Background:The older patient group with inflammatory bowel diseases (IBD) is particularly vulnerable to consequences of disease and therapy-related side effects but little is known about the best treatment options in this population. Aim:To compare safety and efficacy of tumor necrosis factor α antagonist (anti-TNF) or vedolizumab (VDZ) in patients with IBD >60 years of age.Methods: This retrospective study included patients with Crohn's disease (CD) or ulcerative colitis (UC) initiating anti-TNF or VDZ therapy ≥60 years of age at three study sites. We examined occurrence of infection or malignancy within 1 year after therapy as our primary outcome. Our efficacy outcomes included clinical remission at 3, 6 and 12 months. Multivariable logistic regression models adjusting for relevant confounders estimated odds ratios (OR) and 95% confidence intervals. Results:The study included 131 anti-TNF and 103 VDZ initiated patients (age range 60-88 years). Approximately half had CD. At 1 year, there were no significant differences in safety profile between the two therapeutic classes. Infections were observed in 20% of anti-TNF-treated and 17% of VDZ-treated patients (P = 0.54).Pneumonia was the most common infection in both groups. While more anti-TNFtreated CD patients were in remission at 3 months compared to VDZ (OR 2.82, 95% CI 1.18-6.76), this difference was not maintained at 6 and 12 months suggesting similar efficacy of both classes. Conclusions:Both anti-TNF and VDZ therapy were similarly effective and safe in elderly IBD patients.

Comparative Analysis of the 3-Year Persistence Rate with Second-Line Vedolizumab and Tumor Necrosis Factor-α Inhibitors in Patients with Inflammatory Bowel Disease Followed in Gastroenterology Practices in Germany

“…Vedolizumab is an α 4 β 7 integrin antagonist that inhibits T-cell adhesion and infiltration into the gut epithelium [5]. Previously published research has compared the efficacy of vedolizumab with other biological drugs in patients diagnosed with IBD [10][11][12][13][14][15].…”

Elderly patients with inflammatory bowel disease: Updated review of the therapeutic landscape

“…In the previously-mentioned Adar et al trial, 234 elderly-onset patients were assessed retrospectively at the time of biologic initiation, separated in two groups: anti-TNF agents ( n = 131) and vedolizumab ( n = 103)[53]. As can be expected, the main measurable difference between groups was the increased proportions of perianal disease in the anti-TNF group (25% vs 14%, P = 0.02).…”

“…More recent data has suggested sustained efficacy rates over a twelve-month period, although not compared to a younger population. In a large multicenter, retrospective trial by Adar et al[53], 131 elderly IBD patients on anti-TNF maintained remission status, defined as a peer-reviewed clinical, biochemical and endoscopic assessment, in 50% of cases at 3 mo, 54% at 6 mo and 58% at 12 mo. Lower rates of remissions were associated with increasing age (for each one-year increase in age: OR = 0.94, 95%CI: 0.89-0.99).…”

“…Incidence rates of Clostridium difficile infection and gastrointestinal infections were also similar between groups (21% vs 18%, P = 0.57). New primary or recurrent malignancies were diagnosed in 3% of anti-TNF patients and 1% of vedolizumab-treated patients, although not statistically significant ( P = 0.27)[53]. The Adar et al[53] study is the largest to compare efficacy and safety of biologic agents in the elderly IBD population.…”

“…New primary or recurrent malignancies were diagnosed in 3% of anti-TNF patients and 1% of vedolizumab-treated patients, although not statistically significant ( P = 0.27)[53]. The Adar et al[53] study is the largest to compare efficacy and safety of biologic agents in the elderly IBD population. As opposed to extrapolations from the GEMINI data (similar rates of infections between vedolizumab and placebo arms), the findings from Adar et al[53] do not capture significantly lower rates of infections compared to anti-TNF agents, possibly explained by the small sample size, short follow-up period and retrospective nature of the trial.…”