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

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.

Keywords: Crohn’s disease; Inflammatory bowel disease; Real-world effectiveness; Ulcerative colitis; Vedolizumab.

Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Meta-analysis of clinical remission rates among patients with ulcerative colitis receiving vedolizumab at the time points: a week 6; b week 14; c 6 months; and d 12 months. The size of each square represents the weight assigned to each study based on sample size. Error bars represent 95% CIs. Diamonds represent the point estimate of the averaged study rates; the lateral tips of the diamonds represent 95% CIs. CI confidence interval. Data from Amiot et al. [65], Baumgart et al. [24], Mankongpaisarnrung et al. [33], Shelton et al. [13], Ungar et al. [39], Chaparro et al. [25], Christensen et al. [27] Kopylov et al. [86], Samaan et al. [36], Vivio et al. [40], Dulai et al. [28], Hoog et al. [30], Stallmach et al. [38], Zezos et al. [42], Eriksson et al. [29], Lenti et al. [32], Pauwels et al. [34], Samaan et al.a. aUnpublished clinical data provided courtesy of Dr. Mark A. Samaan and Dr. Peter Irving from their UK study, 2016
Fig. 2
Fig. 2
Meta-analysis of clinical remission rates among patients with Crohn’s disease receiving vedolizumab at the time points: a week 6; b week 14; c 6 months; and d 12 months. The size of each square represents the weight assigned to each study based on sample size. Error bars represent 95% CIs. Diamonds represent the point estimate of the averaged study rates; the lateral tips of the diamonds represent 95% CIs. CI confidence interval. Data from Amiot et al. [23], Baumgart et al. [24], Dulai et al. [46], Gils et al. [47], Shelton et al. [13], Ungar et al. [39], Abramowitz et al. [43], Blum et al. [44], Chaparro et al. [25], Christensen et al. [27], Glover et al. [48], Kopylov et al. [86], Samaan et al. [36], De Vos et al. [45], Hoog et al. [30], Stallmach et al. [38], Eriksson et al. [29], Lenti et al. [32], Pauwels et al. [34], Samaan et al.a. aUnpublished clinical data provided courtesy of Dr. Mark A. Samaan and Dr. Peter Irving from their UK study, 2016
Fig. 3
Fig. 3
Meta-analysis of CS-free clinical remission rates among patients with ulcerative colitis receiving vedolizumab at the time points: a week 6; b week 14; c 6 months; and d 12 months. The size of each square represents the weight assigned to each study based on sample size. Error bars represent 95% CIs. Diamonds represent the point estimate of the averaged study rates; the lateral tips of the diamonds represent 95% CIs. CI confidence interval, CS corticosteroid. Data from Amiot et al. [65], Baumgart et al. [24], Kopylov et al. [86], Samaan et al. [36], Shelton et al. [13], Peerani et al. [35], Samaan et al.a, Stallmach et al. [38], Zezos et al. [42], Dulai et al. [28], Eriksson et al. [29]. aUnpublished clinical data provided courtesy of Dr. Mark A. Samaan and Dr. Peter Irving from their UK study, 2016
Fig. 4
Fig. 4
Meta-analysis of CS-free clinical remission rates among patients with Crohn’s disease receiving vedolizumab at the time points: a week 6; b week 14; c 6 months; and d 12 months. The size of each square represents the weight given to each study based on sample size. Error bars represent 95% CIs. Diamonds represent the point estimate of the averaged study rates; the lateral tips of the diamonds represent 95% CIs. CI confidence interval, CS corticosteroid. Data from Amiot et al. [23], Baumgart et al. [24], Dulai et al. [46], Kopylov et al. [86], Samaan et al. [36], Shelton et al. [13], Dulai et al. [46], Samaan et al.a, Stallmach et al. [38], Eriksson et al. [29]. aUnpublished clinical data provided courtesy of Dr. Mark A. Samaan and Dr. Peter Irving from their UK study, 2016
Fig. 5
Fig. 5
Mucosal healing rates among patients with ulcerative colitis (a) or Crohn’s disease (b) receiving vedolizumab. Square size represents the weight given to each study, based on sample size. Error bars represent 95% CIs. CI confidence interval. Christensen et al. [69], Chaudrey et al. [26], Schmidt et al. [103], Gils et al. (a) [47], Gils et al. (b) [77], Pauwels et al. [34], Vivio et al. [40], Peerani et al. [35], Kochhar et al. [83], Dulai et al. (a) [28], Amiot et al. [23], Dulai et al. (b) [46]. aMedian time point. bOnly patients with ≥ 1 follow-up assessment at the specified time point were included in the analyses. Data from the VICTORY Consortium, which contributed the majority of mucosal healing data, used a cumulative incidence analysis, and remaining studies employed a “complete” case approach
Fig. 6
Fig. 6
Subgroup analysis by geographical location showing clinical remission rates among patients with a ulcerative colitis and b Crohn’s disease. The size of each data bubble is proportional to the corresponding country clinical remission rates. Unless specified otherwise, one study was reported at each geographical location. Random-effects meta-analysis of single proportions was used to calculate an overall proportion in cases of > 1 study

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