A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease: The Cross Pennine study

Marco Vincenzo Lenti, Scott Levison, Elena Eliadou, Robert Willert, Karen Kemp, Anna Carter, Catherine Stansfield, Arash Assadsangabi, Salil Singh, Ben Crooks, Suzanne Tattersall, Francesca Fairhurst, Catherine Kenneth, Sreedhar Subramanian, Chris Probert, Daniel Storey, Belle Gregg, Paul Smith, Eleanor Liu, Jimmy K. LimdiAlex Johnston, Peter John Hamlin, Christian P. Selinger

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Real-life data on vedolizumab effectiveness in inflammatory bowel disease (IBD) are still emerging. Data on the comparative safety of the gut selective profile are of particular interest. Aims: To assess clinical outcome and safety in IBD patients treated with vedolizumab. Methods: We retrospectively collected data of patients treated with vedolizumab at eight UK hospitals (August 2014–January 2018). Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Possible predictors of clinical response were examined. Results: Two hundred and three IBD patients (mean treatment 16 ± 8 months) were included. Of these, 135 patients (mean age 40.6 ± 16.0 years; F:M 1.9:1) had CD and 68 (mean age 44.5 ± 18.1 years; F:M 1:1.2) had UC. According to PGA, 106/135 (78.5%) CD and 62/68 (91.2%) UC patients (p = 0.02) had a clinical response/remission at 14 weeks, whereas 76/119 (63.9%) CD and 52/63 (82.5%) UC patients (p < 0.01) showed a sustained response or remission at 52 weeks, with a high adherence rate (97%). No predictors of clinical response were found. The cumulative incidence of infectious diseases was 11.9 per 100 person-years. Conclusion: Vedolizumab is an effective therapy for inducing and maintaining remission of IBD, with better results for UC, and with a good safety profile.

Original languageEnglish
JournalDigestive and Liver Disease
DOIs
Publication statusAccepted/In press - Jan 1 2018
Externally publishedYes

Fingerprint

Inflammatory Bowel Diseases
Safety
Physicians
Communicable Diseases
vedolizumab
Incidence
Therapeutics

Keywords

  • Biological therapy
  • Clinical predictors
  • Crohn's disease
  • Elderly
  • Immunomodulator
  • Ulcerative colitis

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease : The Cross Pennine study. / Lenti, Marco Vincenzo; Levison, Scott; Eliadou, Elena; Willert, Robert; Kemp, Karen; Carter, Anna; Stansfield, Catherine; Assadsangabi, Arash; Singh, Salil; Crooks, Ben; Tattersall, Suzanne; Fairhurst, Francesca; Kenneth, Catherine; Subramanian, Sreedhar; Probert, Chris; Storey, Daniel; Gregg, Belle; Smith, Paul; Liu, Eleanor; Limdi, Jimmy K.; Johnston, Alex; Hamlin, Peter John; Selinger, Christian P.

In: Digestive and Liver Disease, 01.01.2018.

Research output: Contribution to journalArticle

Lenti, MV, Levison, S, Eliadou, E, Willert, R, Kemp, K, Carter, A, Stansfield, C, Assadsangabi, A, Singh, S, Crooks, B, Tattersall, S, Fairhurst, F, Kenneth, C, Subramanian, S, Probert, C, Storey, D, Gregg, B, Smith, P, Liu, E, Limdi, JK, Johnston, A, Hamlin, PJ & Selinger, CP 2018, 'A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease: The Cross Pennine study', Digestive and Liver Disease. https://doi.org/10.1016/j.dld.2018.07.007
Lenti, Marco Vincenzo ; Levison, Scott ; Eliadou, Elena ; Willert, Robert ; Kemp, Karen ; Carter, Anna ; Stansfield, Catherine ; Assadsangabi, Arash ; Singh, Salil ; Crooks, Ben ; Tattersall, Suzanne ; Fairhurst, Francesca ; Kenneth, Catherine ; Subramanian, Sreedhar ; Probert, Chris ; Storey, Daniel ; Gregg, Belle ; Smith, Paul ; Liu, Eleanor ; Limdi, Jimmy K. ; Johnston, Alex ; Hamlin, Peter John ; Selinger, Christian P. / A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease : The Cross Pennine study. In: Digestive and Liver Disease. 2018.
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abstract = "Background: Real-life data on vedolizumab effectiveness in inflammatory bowel disease (IBD) are still emerging. Data on the comparative safety of the gut selective profile are of particular interest. Aims: To assess clinical outcome and safety in IBD patients treated with vedolizumab. Methods: We retrospectively collected data of patients treated with vedolizumab at eight UK hospitals (August 2014–January 2018). Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Possible predictors of clinical response were examined. Results: Two hundred and three IBD patients (mean treatment 16 ± 8 months) were included. Of these, 135 patients (mean age 40.6 ± 16.0 years; F:M 1.9:1) had CD and 68 (mean age 44.5 ± 18.1 years; F:M 1:1.2) had UC. According to PGA, 106/135 (78.5{\%}) CD and 62/68 (91.2{\%}) UC patients (p = 0.02) had a clinical response/remission at 14 weeks, whereas 76/119 (63.9{\%}) CD and 52/63 (82.5{\%}) UC patients (p < 0.01) showed a sustained response or remission at 52 weeks, with a high adherence rate (97{\%}). No predictors of clinical response were found. The cumulative incidence of infectious diseases was 11.9 per 100 person-years. Conclusion: Vedolizumab is an effective therapy for inducing and maintaining remission of IBD, with better results for UC, and with a good safety profile.",
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T1 - A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease

T2 - The Cross Pennine study

AU - Lenti, Marco Vincenzo

AU - Levison, Scott

AU - Eliadou, Elena

AU - Willert, Robert

AU - Kemp, Karen

AU - Carter, Anna

AU - Stansfield, Catherine

AU - Assadsangabi, Arash

AU - Singh, Salil

AU - Crooks, Ben

AU - Tattersall, Suzanne

AU - Fairhurst, Francesca

AU - Kenneth, Catherine

AU - Subramanian, Sreedhar

AU - Probert, Chris

AU - Storey, Daniel

AU - Gregg, Belle

AU - Smith, Paul

AU - Liu, Eleanor

AU - Limdi, Jimmy K.

AU - Johnston, Alex

AU - Hamlin, Peter John

AU - Selinger, Christian P.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: Real-life data on vedolizumab effectiveness in inflammatory bowel disease (IBD) are still emerging. Data on the comparative safety of the gut selective profile are of particular interest. Aims: To assess clinical outcome and safety in IBD patients treated with vedolizumab. Methods: We retrospectively collected data of patients treated with vedolizumab at eight UK hospitals (August 2014–January 2018). Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Possible predictors of clinical response were examined. Results: Two hundred and three IBD patients (mean treatment 16 ± 8 months) were included. Of these, 135 patients (mean age 40.6 ± 16.0 years; F:M 1.9:1) had CD and 68 (mean age 44.5 ± 18.1 years; F:M 1:1.2) had UC. According to PGA, 106/135 (78.5%) CD and 62/68 (91.2%) UC patients (p = 0.02) had a clinical response/remission at 14 weeks, whereas 76/119 (63.9%) CD and 52/63 (82.5%) UC patients (p < 0.01) showed a sustained response or remission at 52 weeks, with a high adherence rate (97%). No predictors of clinical response were found. The cumulative incidence of infectious diseases was 11.9 per 100 person-years. Conclusion: Vedolizumab is an effective therapy for inducing and maintaining remission of IBD, with better results for UC, and with a good safety profile.

AB - Background: Real-life data on vedolizumab effectiveness in inflammatory bowel disease (IBD) are still emerging. Data on the comparative safety of the gut selective profile are of particular interest. Aims: To assess clinical outcome and safety in IBD patients treated with vedolizumab. Methods: We retrospectively collected data of patients treated with vedolizumab at eight UK hospitals (August 2014–January 2018). Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Possible predictors of clinical response were examined. Results: Two hundred and three IBD patients (mean treatment 16 ± 8 months) were included. Of these, 135 patients (mean age 40.6 ± 16.0 years; F:M 1.9:1) had CD and 68 (mean age 44.5 ± 18.1 years; F:M 1:1.2) had UC. According to PGA, 106/135 (78.5%) CD and 62/68 (91.2%) UC patients (p = 0.02) had a clinical response/remission at 14 weeks, whereas 76/119 (63.9%) CD and 52/63 (82.5%) UC patients (p < 0.01) showed a sustained response or remission at 52 weeks, with a high adherence rate (97%). No predictors of clinical response were found. The cumulative incidence of infectious diseases was 11.9 per 100 person-years. Conclusion: Vedolizumab is an effective therapy for inducing and maintaining remission of IBD, with better results for UC, and with a good safety profile.

KW - Biological therapy

KW - Clinical predictors

KW - Crohn's disease

KW - Elderly

KW - Immunomodulator

KW - Ulcerative colitis

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