Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease : the IG-IBD LIVE study
© 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd..
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.
| Errataetall: |
CommentIn: Aliment Pharmacol Ther. 2022 Aug;56(4):731-732. - PMID 35879894 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:56 |
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| Enthalten in: |
Alimentary pharmacology & therapeutics - 56(2022), 1 vom: 05. Juli, Seite 95-109 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pugliese, Daniela [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 26.07.2022 Date Revised 30.08.2022 published: Print-Electronic CommentIn: Aliment Pharmacol Ther. 2022 Aug;56(4):731-732. - PMID 35879894 Citation Status MEDLINE |
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| doi: |
10.1111/apt.16923 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease |b the IG-IBD LIVE study |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 26.07.2022 | ||
| 500 | |a Date Revised 30.08.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Aliment Pharmacol Ther. 2022 Aug;56(4):731-732. - PMID 35879894 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. | ||
| 520 | |a 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 | ||
| 520 | |a AIMS: We investigated the effectiveness and safety of vedolizumab in matched cohorts of elderly and nonelderly UC and CD patients | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Crohn’s disease | |
| 650 | 4 | |a biologics (IBD) | |
| 650 | 4 | |a immunosuppression | |
| 650 | 4 | |a ulcerative colitis | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Gastrointestinal Agents |2 NLM | |
| 650 | 7 | |a Tumor Necrosis Factor Inhibitors |2 NLM | |
| 650 | 7 | |a vedolizumab |2 NLM | |
| 650 | 7 | |a 9RV78Q2002 |2 NLM | |
| 700 | 1 | |a Privitera, Giuseppe |e verfasserin |4 aut | |
| 700 | 1 | |a Crispino, Federica |e verfasserin |4 aut | |
| 700 | 1 | |a Mezzina, Nicolò |e verfasserin |4 aut | |
| 700 | 1 | |a Castiglione, Fabiana |e verfasserin |4 aut | |
| 700 | 1 | |a Fiorino, Gionata |e verfasserin |4 aut | |
| 700 | 1 | |a Laterza, Lucrezia |e verfasserin |4 aut | |
| 700 | 1 | |a Viola, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Bertani, Lorenzo |e verfasserin |4 aut | |
| 700 | 1 | |a Caprioli, Flavio |e verfasserin |4 aut | |
| 700 | 1 | |a Cappello, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Barberio, Brigida |e verfasserin |4 aut | |
| 700 | 1 | |a Ricci, Chiara |e verfasserin |4 aut | |
| 700 | 1 | |a Balestrieri, Paola |e verfasserin |4 aut | |
| 700 | 1 | |a Daperno, Marco |e verfasserin |4 aut | |
| 700 | 1 | |a Pluchino, Dario |e verfasserin |4 aut | |
| 700 | 1 | |a Rizzello, Fernando |e verfasserin |4 aut | |
| 700 | 1 | |a Scribano, Maria Lia |e verfasserin |4 aut | |
| 700 | 1 | |a Sablich, Renato |e verfasserin |4 aut | |
| 700 | 1 | |a Pastorelli, Luca |e verfasserin |4 aut | |
| 700 | 1 | |a Manguso, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Variola, Angela |e verfasserin |4 aut | |
| 700 | 1 | |a Di Sario, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Grossi, Laurino |e verfasserin |4 aut | |
| 700 | 1 | |a Armuzzi, Alessandro |e verfasserin |4 aut | |
| 700 | 0 | |a IG‐IBD LIVE Study Group |e verfasserin |4 aut | |
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| 700 | 1 | |a Biscaglia, Giuseppe |e investigator |4 oth | |
| 700 | 1 | |a Buda, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Mocci, Giammarco |e investigator |4 oth | |
| 700 | 1 | |a Viscido, Angelo |e investigator |4 oth | |
| 700 | 1 | |a Di Paolo, Maria Carla |e investigator |4 oth | |
| 700 | 1 | |a Onali, Sara |e investigator |4 oth | |
| 700 | 1 | |a Rodino, Stefano |e investigator |4 oth | |
| 700 | 1 | |a Coletta, Marina |e investigator |4 oth | |
| 700 | 1 | |a Principi, Mariabeatrice |e investigator |4 oth | |
| 700 | 1 | |a Miranda, Agnese |e investigator |4 oth | |
| 700 | 1 | |a Amato, Arnaldo |e investigator |4 oth | |
| 700 | 1 | |a Bezzio, Cristina |e investigator |4 oth | |
| 700 | 1 | |a Petruzzellis, Carlo |e investigator |4 oth | |
| 700 | 1 | |a Mazzuoli, Silvia |e investigator |4 oth | |
| 700 | 1 | |a Festa, Stefano |e investigator |4 oth | |
| 700 | 1 | |a Sartini, Alessandro |e investigator |4 oth | |
| 700 | 1 | |a Checchin, Davide |e investigator |4 oth | |
| 700 | 1 | |a Fanigliulo, Libera |e investigator |4 oth | |
| 700 | 1 | |a Gallina, Sara |e investigator |4 oth | |
| 700 | 1 | |a Cesarini, Monica |e investigator |4 oth | |
| 700 | 1 | |a Bodini, Giorgia |e investigator |4 oth | |
| 700 | 1 | |a Stradella, Davide |e investigator |4 oth | |
| 700 | 1 | |a Spagnuolo, Rocco |e investigator |4 oth | |
| 700 | 1 | |a Guidi, Luisa |e investigator |4 oth | |
| 700 | 1 | |a Savarino, Edoardo |e investigator |4 oth | |
| 700 | 1 | |a Scrivo, Barbara |e investigator |4 oth | |
| 700 | 1 | |a Soru, Pietro |e investigator |4 oth | |
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