Abstract
Background. Vedolizumab is a gut-selective monoclonal anti-α4β7-integrin antibody approved for the treatment of adults with moderately to severely active Crohn’s disease (CD). Aim. To conduct a systematic literature review and meta-analysis of published real-world studies examining mucosal healing (MH) rates in patients with CD treated with vedolizumab in routine clinical practice. Methods. MEDLINE-, Cochrane-, and EMBASE-indexed publications from January 2014 to January 2020 and 2018-2019 conference abstracts were searched for real-world studies reporting MH-related outcomes in vedolizumab-treated adults with CD. A meta-analysis was conducted in R to generate pooled estimates of MH. The primary analysis included studies reporting point estimates of MH/endoscopic remission as absence of ulcers/erosions and/or Simple Endoscopic Score for CD (SES-CD) cut − points < 4 , at 6 and 12 months. Results. The systematic literature review included 36 studies, predominantly of antitumour necrosis factor-experienced patients. MH and endoscopic remission were the most frequently reported endpoints. MH rates were 10.1%-46.0% at 6 months (ten studies) and 21.2%-62.5% at 12 months (eight studies). Fifteen studies defining MH as absence of ulcers/erosions and/or SES-CD cut − points < 4 were included for meta-analysis. Pooled MH rates for the primary analysis were 31.8% at 6 months (95% confidence interval (CI): 25.6-38.3; five studies, N = 223 ) and 33.4% at 12 months (95% CI: 25.9-41.4; three studies, N = 151 ). Conclusion. Approximately one-third of vedolizumab-treated patients with CD achieved MH at both 6 and 12 months in real-world clinical settings, despite utilisation in largely biologic-refractory patients. These findings confirm the effectiveness of vedolizumab for achieving MH in patients with CD.
Highlights
Crohn’s disease (CD) is a chronic and progressive inflammatory bowel disease in which uncontrolled inflammation can lead to structural bowel damage, causing long-term debilitating complications that often require surgery [1,2,3]
Treatment goals have recently evolved from symptom-based management toward control of inflammation to prevent bowel damage and promote mucosal healing (MH; as assessed by objective measures such as endoscopy) [4,5,6]
Most studies in the systematic literature review (SLR) were single-arm, retrospective cohort studies conducted in a single country (10/36 from the United States)
Summary
Crohn’s disease (CD) is a chronic and progressive inflammatory bowel disease in which uncontrolled inflammation can lead to structural bowel damage, causing long-term debilitating complications that often require surgery [1,2,3]. Aim. To conduct a systematic literature review and meta-analysis of published real-world studies examining mucosal healing (MH) rates in patients with CD treated with vedolizumab in routine clinical practice. MEDLINE-, Cochrane-, and EMBASE-indexed publications from January 2014 to January 2020 and 2018-2019 conference abstracts were searched for real-world studies reporting MH-related outcomes in vedolizumab-treated adults with CD. The primary analysis included studies reporting point estimates of MH/endoscopic remission as absence of ulcers/erosions and/or Simple Endoscopic Score for CD (SESCD) cut − points < 4, at 6 and 12 months. Fifteen studies defining MH as absence of ulcers/erosions and/or SES-CD cut − points < 4 were included for meta-analysis. One-third of vedolizumab-treated patients with CD achieved MH at both 6 and 12 months in real-world clinical settings, despite utilisation in largely biologic-refractory patients. These findings confirm the effectiveness of vedolizumab for achieving MH in patients with CD
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