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, Edward Vincent
N1 - Funding Information:
The systematic literature review (including assessment of the level of evidence) was performed by PHMR Limited. Unpublished clinical data were provided courtesy of Dr. Mark A. Samaan and Dr. Peter Irving from their UK study, 2016. The authors also wish to acknowledge Ray Liu and Yanyan Zhu for their helpful discussions. We thank Vinay Pasupuleti, PhD, and Rezan Sahinkaya, PhD, ProEd Communications, Inc., for medical editorial assistance with this manuscript. All authors have approved the final version of the article, including the authorship list. 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). Rebecca Curtis was an employee of Takeda at the time of manuscript development. Stefan Schreiber has received honoraria from AbbVie, Celltrion, MSD, Pfizer, and Takeda. Axel Dignass has no conflict of interest. Laurent Peyrin-Biroulet has received lecture fees from MSD, Abbvie, Janssen, Takeda, Celltrion, Pfizer, BMS, Pharmacosmos, Shire, Genentech, Mitsubishi, Ferring, Norgine, Tillots, Vifor, UCB Pharma, Hospira, Boehringer-Ingelheim, and Lilly. Greg Hather owns stock in Takeda Pharmaceuticals and is an employee of Takeda Global Research and Development. Dirk Demuth is an employee of Takeda International, UK Branch. Mahmoud Mosli has no conflict of interest. Rebecca Curtis is a former employee of Takeda International, UK Branch. Javaria Mona Khalid owns stock in Takeda Pharmaceuticals International and is an employee of Takeda International, UK Branch. Edward V. Loftus, Jr, has received research support from and has served as a consultant for Takeda.
Publisher Copyright:
© 2018, The Author(s).
PY - 2018/9/1
Y1 - 2018/9/1
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
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U2 - 10.1007/s00535-018-1480-0
DO - 10.1007/s00535-018-1480-0
M3 - Article
C2 - 29869016
AN - SCOPUS:85047979975
VL - 53
SP - 1048
EP - 1064
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
SN - 0944-1174
IS - 9
ER -