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
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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. / Attauabi, Mohamed; Höglund, Camilla; Fassov, Janne; Pedersen, Kenneth Bo; Hansen, Heidi Bansholm; Wildt, Signe; Jensen, Michael Dam; Neumann, Anders; Lind, Cecilie; Jacobsen, Henrik Albaek; Popa, Ana Maria; Kjeldsen, Jens; Pedersen, Natalia; Molazahi, Akbar; Haderslev, Kent; Aalykke, Claus; Knudsen, Torben; Cebula, Wojciech; Munkholm, Pia; Bendtsen, Flemming; Seidelin, Jakob Benedict; Burisch, Johan.
I: Scandinavian Journal of Gastroenterology, Bind 56, Nr. 9, 2021, s. 1040-1048.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Vedolizumab as first-line biological therapy in elderly patients and those with contraindications for anti-TNF therapy
T2 - a real-world, nationwide cohort of patients with inflammatory bowel diseases
AU - Attauabi, Mohamed
AU - Höglund, Camilla
AU - Fassov, Janne
AU - Pedersen, Kenneth Bo
AU - Hansen, Heidi Bansholm
AU - Wildt, Signe
AU - Jensen, Michael Dam
AU - Neumann, Anders
AU - Lind, Cecilie
AU - Jacobsen, Henrik Albaek
AU - Popa, Ana Maria
AU - Kjeldsen, Jens
AU - Pedersen, Natalia
AU - Molazahi, Akbar
AU - Haderslev, Kent
AU - Aalykke, Claus
AU - Knudsen, Torben
AU - Cebula, Wojciech
AU - Munkholm, Pia
AU - Bendtsen, Flemming
AU - Seidelin, Jakob Benedict
AU - Burisch, Johan
N1 - Publisher Copyright: © 2021 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - bio-naïve
KW - Crohn’s disease
KW - efficacy
KW - first-line biologics
KW - Inflammatory bowel disease
KW - nationwide
KW - population-based
KW - real-world
KW - safety
KW - ulcerative colitis
KW - vedolizumab
U2 - 10.1080/00365521.2021.1946588
DO - 10.1080/00365521.2021.1946588
M3 - Journal article
C2 - 34224299
AN - SCOPUS:85109690316
VL - 56
SP - 1040
EP - 1048
JO - Scandinavian Journal of Gastroenterology
JF - Scandinavian Journal of Gastroenterology
SN - 0036-5521
IS - 9
ER -
ID: 276082444