Vedolizumab as first-line biological therapy in elderly patients and those with contraindications for anti-TNF therapy : a real-world, nationwide cohort of patients with inflammatory bowel diseases
BACKGROUND: Data from real-life populations about vedolizumab as first-line biological therapy for ulcerative colitis (UC) and Crohn's disease (CD) are emerging.
OBJECTIVE: To investigate the efficacy and safety of vedolizumab in bio-naïve patients with UC and CD.
METHODS: A Danish nationwide cohort study was conducted between November 2014 and November 2019. Primary outcomes were clinical remission, steroid-free clinical remission, and sustained clinical remission from weeks 14 through 52.
RESULTS: The study included 56 patients (UC:31, CD:25) who initiated treatment with vedolizumab mainly because of contraindications to anti-TNFs, of whom 54.8 and 24.0%, respectively received systemic steroids at the initiation. Rates of clinical remission at weeks 6, 14, and 52 were 32.0, 48.0, and 40.0%, respectively, in UC, and 36.8, 36.8, and 47.4% in CD. Steroid-free clinical remission at week 52 was achieved among 36.0 and 47.4% of UC and CD patients, while sustained clinical remission was achieved in 32.0 and 36.8%. Lack of remission was associated with being female (68.8 vs. 11.1%, p = .01) in UC and non-structuring, non-penetrating behavior in CD (90.0 vs. 44.4%, p = .03); however, this was not confirmed in multivariate analysis. Discontinuation due to primary non-response occurred in 20.0 and 5.3% of UC and CD patients, respectively, while rates of secondary loss of response were 12.0 and 5.3% after 52 weeks of follow-up. Vedolizumab was well-tolerated as only one UC patient experienced a serious adverse event.
CONCLUSION: Vedolizumab is effective in the achievement of short-term, long-term, and steroid-free clinical remission in bio-naïve UC and CD patients.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:56 |
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| Enthalten in: |
Scandinavian journal of gastroenterology - 56(2021), 9 vom: 17. Sept., Seite 1040-1048 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Attauabi, Mohamed [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 22.10.2021 Date Revised 31.05.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1080/00365521.2021.1946588 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 100 | 1 | |a Attauabi, Mohamed |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Vedolizumab as first-line biological therapy in elderly patients and those with contraindications for anti-TNF therapy |b a real-world, nationwide cohort of patients with inflammatory bowel diseases |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 22.10.2021 | ||
| 500 | |a Date Revised 31.05.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Data from real-life populations about vedolizumab as first-line biological therapy for ulcerative colitis (UC) and Crohn's disease (CD) are emerging | ||
| 520 | |a OBJECTIVE: To investigate the efficacy and safety of vedolizumab in bio-naïve patients with UC and CD | ||
| 520 | |a METHODS: A Danish nationwide cohort study was conducted between November 2014 and November 2019. Primary outcomes were clinical remission, steroid-free clinical remission, and sustained clinical remission from weeks 14 through 52 | ||
| 520 | |a RESULTS: The study included 56 patients (UC:31, CD:25) who initiated treatment with vedolizumab mainly because of contraindications to anti-TNFs, of whom 54.8 and 24.0%, respectively received systemic steroids at the initiation. Rates of clinical remission at weeks 6, 14, and 52 were 32.0, 48.0, and 40.0%, respectively, in UC, and 36.8, 36.8, and 47.4% in CD. Steroid-free clinical remission at week 52 was achieved among 36.0 and 47.4% of UC and CD patients, while sustained clinical remission was achieved in 32.0 and 36.8%. Lack of remission was associated with being female (68.8 vs. 11.1%, p = .01) in UC and non-structuring, non-penetrating behavior in CD (90.0 vs. 44.4%, p = .03); however, this was not confirmed in multivariate analysis. Discontinuation due to primary non-response occurred in 20.0 and 5.3% of UC and CD patients, respectively, while rates of secondary loss of response were 12.0 and 5.3% after 52 weeks of follow-up. Vedolizumab was well-tolerated as only one UC patient experienced a serious adverse event | ||
| 520 | |a CONCLUSION: Vedolizumab is effective in the achievement of short-term, long-term, and steroid-free clinical remission in bio-naïve UC and CD patients | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Crohn’s disease | |
| 650 | 4 | |a Inflammatory bowel disease | |
| 650 | 4 | |a bio-naïve | |
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| 650 | 4 | |a vedolizumab | |
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| 650 | 7 | |a Tumor Necrosis Factor Inhibitors |2 NLM | |
| 650 | 7 | |a vedolizumab |2 NLM | |
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| 700 | 1 | |a Fassov, Janne |e verfasserin |4 aut | |
| 700 | 1 | |a Pedersen, Kenneth Bo |e verfasserin |4 aut | |
| 700 | 1 | |a Hansen, Heidi Bansholm |e verfasserin |4 aut | |
| 700 | 1 | |a Wildt, Signe |e verfasserin |4 aut | |
| 700 | 1 | |a Jensen, Michael Dam |e verfasserin |4 aut | |
| 700 | 1 | |a Neumann, Anders |e verfasserin |4 aut | |
| 700 | 1 | |a Lind, Cecilie |e verfasserin |4 aut | |
| 700 | 1 | |a Jacobsen, Henrik Albaek |e verfasserin |4 aut | |
| 700 | 1 | |a Popa, Ana-Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Kjeldsen, Jens |e verfasserin |4 aut | |
| 700 | 1 | |a Pedersen, Natalia |e verfasserin |4 aut | |
| 700 | 1 | |a Molazahi, Akbar |e verfasserin |4 aut | |
| 700 | 1 | |a Haderslev, Kent |e verfasserin |4 aut | |
| 700 | 1 | |a Aalykke, Claus |e verfasserin |4 aut | |
| 700 | 1 | |a Knudsen, Torben |e verfasserin |4 aut | |
| 700 | 1 | |a Cebula, Wojciech |e verfasserin |4 aut | |
| 700 | 1 | |a Munkholm, Pia |e verfasserin |4 aut | |
| 700 | 1 | |a Bendtsen, Flemming |e verfasserin |4 aut | |
| 700 | 1 | |a Seidelin, Jakob Benedict |e verfasserin |4 aut | |
| 700 | 1 | |a Burisch, Johan |e verfasserin |4 aut | |
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