Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease.

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.

• Authors: Stefan Schreiber, Axel Dignass, Laurent Peyrin-Biroulet, Greg Hather, Dirk Demuth, Mahmoud Mosli, Rebecca Curtis, Javaria Mona Khalid, Edward Vincent Loftus Jr
• Journal: Journal of gastroenterology (J Gastroenterol) Vol. 53 Issue 9 Pg. 1048-1064 (Sep 2018) ISSN: 1435-5922 [Electronic] Japan
• PMID: 29869016 (Publication Type: Journal Article, Meta-Analysis, Systematic Review)

Chemical References

• Antibodies, Monoclonal, Humanized
• Gastrointestinal Agents
• vedolizumab

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Gastrointestinal Agents (adverse effects, therapeutic use)
• Humans
• Inflammatory Bowel Diseases (drug therapy)
• Intestinal Mucosa (drug effects, physiopathology)
• Middle Aged
• Remission Induction
• Treatment Outcome