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.

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

Daperno M.;Ribaldone D. G.;Stradella D.;
2022-01-01

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.
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biologics (IBD); Crohn’s disease; immunosuppression; ulcerative colitis; Aged; Antibodies, Monoclonal, Humanized; Chronic Disease; Colitis, Ulcerative; Crohn Disease; Humans; Prospective Studies; Retrospective Studies; Treatment Outcome; Tumor Necrosis Factor Inhibitors; Gastrointestinal Agents; Inflammatory Bowel Diseases
Pugliese D.; Privitera G.; Crispino F.; Mezzina N.; Castiglione F.; Fiorino G.; Laterza L.; Viola A.; Bertani L.; Caprioli F.; Cappello M.; Barberio B.; Ricci C.; Balestrieri P.; Daperno M.; Pluchino D.; Rizzello F.; Scribano M.L.; Sablich R.; Pastorelli L.; Manguso F.; Variola A.; Di Sario A.; Grossi L.; Armuzzi A.; Ribaldone D.G.; Biscaglia G.; Buda A.; Mocci G.; Viscido A.; Di Paolo M.C.; Onali S.; Rodino S.; Coletta M.; Principi M.; Miranda A.; Amato A.; Bezzio C.; Petruzzellis C.; Mazzuoli S.; Festa S.; Sartini A.; Checchin D.; Fanigliulo L.; Gallina S.; Cesarini M.; Bodini G.; Stradella D.; Spagnuolo R.; Guidi L.; Savarino E.; Scrivo B.; Soru P.; Costa F.; Fries W.; Scaldaferri F.; Allocca M.; Pellegrini L.; Massari A.; Orlando A.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1871158
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