Abstract
BackgroundSelective patient recruitment can produce discrepancies between clinical trial results and real-world effectiveness.MethodsA 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.ResultsAt 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.ConclusionsVedolizumab 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.
Highlights
Current treatment options for inflammatory bowel diseases (IBD) include aminosalicylates, corticosteroids (CS), thiopurines, calcineurin inhibitors, anti-cytokines, and antiintegrins [1, 2]
MEDLINE, MEDLINE In-Process, EMBASE, and Cochrane databases were searched for real-world studies of vedolizumab in adult patients with ulcerative colitis (UC)/Crohn’s disease (CD) reporting clinical response, remission, corticosteroid-free remission, UC/CD-related surgery or hospitalization, mucosal healing, or safety published from May 1, This study was previously presented as a poster at the 2016 Advances in Inflammatory Bowel Diseases Congress (AIBD) and the 2017 European Crohn’s and Colitis Organisation Congress (ECCO)
Studies were eligible if they included real-world evidence and an adult patient population (C 18 years when initiating vedolizumab) receiving vedolizumab (Takeda Pharmaceuticals International, Inc., Deerfield, IL) for IBD (UC, CD, or unspecified/ indeterminate colitis) and if outcomes reported were of interest
Summary
Current treatment options for inflammatory bowel diseases (IBD) include aminosalicylates, corticosteroids (CS), thiopurines, calcineurin inhibitors, anti-cytokines, and antiintegrins [1, 2]. Physicians require real-world effectiveness data to complement clinical trial results and inform treatment decisions. Assessing the treatment quality and effect size in clinical practice and evaluating the strength of this evidence through systematic literature reviews and meta-analyses can provide such data. 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, This study was previously presented as a poster at the 2016 Advances in Inflammatory Bowel Diseases Congress (AIBD) and the 2017 European Crohn’s and Colitis Organisation Congress (ECCO).
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
