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 language | English (US) |
|---|---|
| Pages (from-to) | 1-17 |
| Number of pages | 17 |
| Journal | Journal of Gastroenterology |
| DOIs | |
| State | Accepted/In press - Jun 4 2018 |
| Externally published | Yes |
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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 journal › Article
}
TY - JOUR
T1 - Systematic review with meta-analysis
T2 - real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease
AU - Schreiber, Stefan
AU - Dignass, Axel
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
PY - 2018/6/4
Y1 - 2018/6/4
N2 - 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.
AB - 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.
KW - Crohn’s disease
KW - Inflammatory bowel disease
KW - Real-world effectiveness
KW - Ulcerative colitis
KW - Vedolizumab
UR - http://www.scopus.com/inward/record.url?scp=85047979975&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85047979975&partnerID=8YFLogxK
U2 - 10.1007/s00535-018-1480-0
DO - 10.1007/s00535-018-1480-0
M3 - Article
SP - 1
EP - 17
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
SN - 0944-1174
ER -