P530 Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn’s disease - a systematic review with meta-analysis
Attauabi, M.(1,2,3);Madsen, G.R.(1,2);Bendtsen, F.(1,2);Seidelin, J.B.(3);Burisch, J.(2);
(1)Copenhagen University Hospital- Hvidovre, Gastrounit- Medical Section, Hvidovre, Denmark;(2)University of Copenhagen- Hvidovre Hospital, Copenhagen Center for Inflammatory Bowel Disease in Children- Adolescents and Adults, Hvidovre, Denmark;(3)Herlev Hospital- University of Copenhagen, Department of Gastroenterology and Hepatology, Herlev, Denmark;
Background
Several studies have indicated a reduced efficacy of vedolizumab among patients with ulcerative colitis (UC) and Crohn’s disease (CD) previously exposed to biological therapies. The purpose of this study was to determine the efficacy and safety of vedolizumab among bio-naïve patients with UC or CD as compared with bio-exposed patients.
Methods
The systematic review and meta-analysis were conducted according to Cochrane’s recommendations. PubMed, EMBASE, and The Cochrane Library databases were searched from database inception till December 2020 for studies that reported any efficacy or safety outcome among bio-naïve patients with UC or CD receiving vedolizumab. Meta-analyses were performed using a random-effects model based on the inverse-variance method. The methodological quality of was assessed in line with National Institute for Health and Care Excellence (NICE) guidelines.
Results
The systematic search identified 79 eligible studies, including a total of 2,830 and 2,381 bio-naïve patients with UC and CD, respectively, compared with 7,392 and 10,511 bio-exposed patients, respectively. The mean NOS score was 6.0 and 6.1 in UC and CD, respectively. Meta-analysis showed that bio-naïve patients with UC more frequently achieved clinical remission at week 14 (risk ratio (RR)=1.27 [95% confidence interval (CI) 1.00, 1.62]) and week 52 (RR=1.25 [95% CI 1.11, 1.42]) compared to bio-exposed patients. Similar results were found in terms of steroid-free clinical remission at week 52 (RR= 1.36 [95% CI 1.06, 1.76]). Likewise, bio-naïve patients with CD were more likely to achieve clinical remission at week 52 (RR= 1.23 [95% CI 1.05, 1.43]), while clinical remission at week 14 and steroid-free clinical remission could not be assessed in a meta-analysis. A similar pattern was observed regarding the achievement of endoscopic remission at week 52 in UC (RR= 1.48 [95% CI 1.28, 1.72]) but not in CD (RR=1.48 [95% CI 0.82, 2.65]) (Tables 1-2).
Finally, bio-naïve UC patients did not experience any difference in rates of adverse events as compared with bio-exposed patients (UC: RR= 0.96 [95% CI 0.70, 1.31]) but experienced significantly less serious adverse events (RR= 0.47 [95% CI 0.26, 0.82]). In line with this, patients with CD experienced fewer adverse events (RR= 0.73 [95% 0.64, 0.83]) and serious adverse events (RR= 0.54 [95% CI 0.34, 0.85]).
Conclusion
This meta-analysis suggests that the reduction of efficacy of vedolizumab following exposure to other biologicals is statistically and clinically significant. Our findings add to the body of evidence regarding tailoring of biological therapies for patients with UC and CD.