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

Pugliese, Daniela;Privitera, Giuseppe;Crispino, Federica;Mezzina, Nicolò;Castiglione, Fabiana;Fiorino, Gionata;Laterza, Lucrezia;Viola, Anna;Bertani, Lorenzo;Caprioli, Flavio;Cappello, Maria;Barberio, Brigida;Ricci, Chiara;Balestrieri, Paola;Daperno, Marco;Pluchino, Dario;Rizzello, Fernando;Scribano, Maria Lia;Sablich, Renato;Pastorelli, Luca;Manguso, Francesco;Variola, Angela;Di Sario, Antonio;Grossi, Laurino;Armuzzi, Alessandro;Onali Sara

2022-01-01

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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-alpha 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.