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. 2022 Jul;56(1):95-109.
doi: 10.1111/apt.16923. Epub 2022 May 12.

Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: the IG-IBD LIVE study

Daniela Pugliese  1 , Giuseppe Privitera  2 , Federica Crispino  3 , Nicolò Mezzina  4 , Fabiana Castiglione  5 , Gionata Fiorino  6 , Lucrezia Laterza  1 , Anna Viola  7 , Lorenzo Bertani  8 , Flavio Caprioli  9 , Maria Cappello  10 , Brigida Barberio  11 , Chiara Ricci  12 , Paola Balestrieri  13 , Marco Daperno  14 , Dario Pluchino  15 , Fernando Rizzello  16 , Maria Lia Scribano  17 , Renato Sablich  18 , Luca Pastorelli  19 , Francesco Manguso  20 , Angela Variola  21 , Antonio Di Sario  22   23 , Laurino Grossi  24 , Alessandro Armuzzi  25   26 ; IG‐IBD LIVE Study Group
Collaborators, Affiliations

Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: the IG-IBD LIVE study

Daniela Pugliese et al. Aliment Pharmacol Ther. 2022 Jul.

Abstract

Background: Vedolizumab registration trials were the first to include elderly patients with moderate-to-severe ulcerative colitis (UC) or Crohn's disease (CD), but few real-life data have been reported in this population.

Aims: We investigated the effectiveness and safety of vedolizumab in matched cohorts of elderly and nonelderly UC and CD patients.

Methods: The Long-term Italian Vedolizumab Effectiveness (LIVE) study is a retrospective-prospective study including UC and CD patients who started vedolizumab from April 2016 to June 2017. Elderly patients (≥65 years) were matched clinically 1:2 to nonelderly patients (18-64 years); the 2 groups were followed until drug discontinuation or June 2019.

Results: The study included 198 elderly (108 UC, 90 CD) and 396 matched nonelderly patients (205 UC, 191 CD). Nonelderly UC patients had a significantly higher persistence on vedolizumab compared to elderly patients (67.6% vs. 51.4%, p = 0.02). No significant difference in effectiveness was observed between elderly and nonelderly CD patients (59.4% vs. 52.4%, p = 0.32). Age ≥65 years was associated with lower persistence in UC; for CD, previous exposure to anti-TNF-α agents, Charlson comorbidity index >2 and moderate-to-severe clinical activity at baseline were associated with lower persistence. There were recorded 130 adverse events, with comparable rates between the two groups. A Charlson comorbidity index >2 was associated with an increased risk of adverse events.

Conclusion: Vedolizumab can be considered a safe option in elderly IBD patients. Its effectiveness in elderly UC patients may be reduced, while no age-dependent effect on effectiveness was observed in CD.

Keywords: Crohn’s disease; biologics (IBD); immunosuppression; ulcerative colitis.

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Figures

FIGURE 1
FIGURE 1
Kaplan–Meier survival curves for the persistency (total number of discontinued patients and number of patients lost to follow‐up) of vedolizumab therapy in elderly versus nonelderly patients with inflammatory bowel disease. (A) Patients with ulcerative colitis. (B) Patients with Crohn’s disease
FIGURE 2
FIGURE 2
Secondary outcomes in UC patients, by study group and time of assessment. (A) Clinical remission. (B) Steroid‐free clinical remission. (C) Biochemical remission. (D) Endoscopic remission. *p < 0.05
FIGURE 3
FIGURE 3
Secondary outcomes in CD patients, by study group and time of assessment. (A) Clinical remission. (B) Steroid‐free clinical remission. (C) Biochemical remission. (D) Endoscopic remission. *p < 0.05
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