Systematic review with meta-analysis

real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease

Stefan Schreiber, Axel Dignass, Laurent Peyrin-Biroulet, Greg Hather, Dirk Demuth, Mahmoud Mosli, Rebecca Curtis, Javaria Mona Khalid, Edward Vincent Loftus, Jr

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Background: Selective patient recruitment can produce discrepancies between clinical trial results and real-world effectiveness. Methods: A systematic literature review and meta-analysis were conducted to assess vedolizumab real-world effectiveness and safety in patients with ulcerative colitis (UC) or Crohn’s disease (CD). MEDLINE, MEDLINE In-Process, EMBASE, and Cochrane databases were searched for real-world studies of vedolizumab in adult patients with UC/CD reporting clinical response, remission, corticosteroid-free remission, UC/CD-related surgery or hospitalization, mucosal healing, or safety published from May 1, 2014–June 22, 2017. Response and remission rates were combined in random-effects meta-analyses. Results: At treatment week 14, 32% of UC patients [95% confidence interval (CI) 27–39%] and 30% of CD patients (95% CI 25–34%) were in remission; and at month 12, 46% for UC (95% CI 37–56%) and 30% for CD (95% CI 20–42%). For UC, the rates of corticosteroid-free remission were 26% at week 14 (95% CI 20–34%) and 42% at month 12 (95% CI 31–53%); for CD they were 25% at week 14 (95%, CI 20–31%) and 31% at month 12 (95%, CI 20–45%). At month 12, 33–77% of UC and 6–63% of CD patients had mucosal healing. Nine percent of patients reported serious adverse events. Conclusions: Vedolizumab demonstrated real-world effectiveness in patients with moderate-to-severely active UC or CD, with approximately one-half and one-third of patients, respectively, in remission at treatment month 12. These findings are consistent with clinical trial data and support the long-term benefit–risk profile of vedolizumab.

Original languageEnglish (US)
Pages (from-to)1-17
Number of pages17
JournalJournal of Gastroenterology
DOIs
StateAccepted/In press - Jun 4 2018
Externally publishedYes

Fingerprint

Ulcerative Colitis
Inflammatory Bowel Diseases
Crohn Disease
Meta-Analysis
Confidence Intervals
Safety
MEDLINE
Adrenal Cortex Hormones
Pragmatic Clinical Trials
vedolizumab
Patient Safety
Patient Selection
Hospitalization
Clinical Trials
Databases
Therapeutics

Keywords

  • Crohn’s disease
  • Inflammatory bowel disease
  • Real-world effectiveness
  • Ulcerative colitis
  • Vedolizumab

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Systematic review with meta-analysis : real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease. / Schreiber, Stefan; Dignass, Axel; Peyrin-Biroulet, Laurent; Hather, Greg; Demuth, Dirk; Mosli, Mahmoud; Curtis, Rebecca; Khalid, Javaria Mona; Loftus, Jr, Edward Vincent.

In: Journal of Gastroenterology, 04.06.2018, p. 1-17.

Research output: Contribution to journalArticle

Schreiber, Stefan ; Dignass, Axel ; Peyrin-Biroulet, Laurent ; Hather, Greg ; Demuth, Dirk ; Mosli, Mahmoud ; Curtis, Rebecca ; Khalid, Javaria Mona ; Loftus, Jr, Edward Vincent. / Systematic review with meta-analysis : real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease. In: Journal of Gastroenterology. 2018 ; pp. 1-17.
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abstract = "Background: Selective patient recruitment can produce discrepancies between clinical trial results and real-world effectiveness. Methods: A systematic literature review and meta-analysis were conducted to assess vedolizumab real-world effectiveness and safety in patients with ulcerative colitis (UC) or Crohn’s disease (CD). MEDLINE, MEDLINE In-Process, EMBASE, and Cochrane databases were searched for real-world studies of vedolizumab in adult patients with UC/CD reporting clinical response, remission, corticosteroid-free remission, UC/CD-related surgery or hospitalization, mucosal healing, or safety published from May 1, 2014–June 22, 2017. Response and remission rates were combined in random-effects meta-analyses. Results: At treatment week 14, 32{\%} of UC patients [95{\%} confidence interval (CI) 27–39{\%}] and 30{\%} of CD patients (95{\%} CI 25–34{\%}) were in remission; and at month 12, 46{\%} for UC (95{\%} CI 37–56{\%}) and 30{\%} for CD (95{\%} CI 20–42{\%}). For UC, the rates of corticosteroid-free remission were 26{\%} at week 14 (95{\%} CI 20–34{\%}) and 42{\%} at month 12 (95{\%} CI 31–53{\%}); for CD they were 25{\%} at week 14 (95{\%}, CI 20–31{\%}) and 31{\%} at month 12 (95{\%}, CI 20–45{\%}). At month 12, 33–77{\%} of UC and 6–63{\%} of CD patients had mucosal healing. Nine percent of patients reported serious adverse events. Conclusions: Vedolizumab demonstrated real-world effectiveness in patients with moderate-to-severely active UC or CD, with approximately one-half and one-third of patients, respectively, in remission at treatment month 12. These findings are consistent with clinical trial data and support the long-term benefit–risk profile of vedolizumab.",
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AU - Peyrin-Biroulet, Laurent

AU - Hather, Greg

AU - Demuth, Dirk

AU - Mosli, Mahmoud

AU - Curtis, Rebecca

AU - Khalid, Javaria Mona

AU - Loftus, Jr, Edward Vincent

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