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 / 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. - In: ALIMENTARY PHARMACOLOGY AND THERAPEUTICS. - ISSN 1365-2036. - 56:1(2022), pp. 95-109. [10.1111/apt.16923]

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

Castiglione, Fabiana;Ricci, Chiara;Pastorelli, Luca;Manguso, Francesco;
2022

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.
2022
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. - In: ALIMENTARY PHARMACOLOGY AND THERAPEUTICS. - ISSN 1365-2036. - 56:1(2022), pp. 95-109. [10.1111/apt.16923]
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/949420
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 24
  • ???jsp.display-item.citation.isi??? 28
social impact