Vedolizumab in early and late Crohn's disease (LOVE-CD): a phase 4 open-label cohort study.
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BACKGROUND: Vedolizumab is efficacious in inducing and maintaining clinical remission in Crohn's disease. However, prospective data about its efficacy in early Crohn's disease are scarce. We aimed to evaluate the ability of vedolizumab to promote clinical, endoscopic, and histological remission in patients with early and late active Crohn's disease over a 1-year period. METHODS: This phase 4 investigator-initiated, open-label cohort study was conducted at 22 hospitals in Belgium, Hungary, and the Netherlands. Eligible patients were adults aged 18-80 years with moderate to severe Crohn's disease (Crohn's Disease Activity Index [CDAI] 220-450, with ulcers at endoscopy). Patients were divided into two groups: those with early Crohn's disease (defined as a diagnosis less than 2 years ago and naive to advanced treatment [naive or only treated with corticosteroids or immunomodulators, or both]); and those with late Crohn's disease (defined as a diagnosis more than 2 years ago and previously treated with corticosteroids, immunomodulators, and anti-TNF agents). Patients received intravenous vedolizumab (300 mg) at weeks 0, 2, and 6, and every 8 weeks thereafter for 52 weeks, with an additional 300 mg infusion at week 10 in the absence of a decrease in CDAI of more than 70 at week 6. Colonoscopies with biopsies were done at screening, week 26, and week 52, and assessed by masked independent readers with the Simple Endoscopic Score for Crohn's disease (SES-CD). The primary endpoint was the proportion of patients with clinical and endoscopic remission (defined as CDAI ≤150 and SES-CD <4) at both week 26 and 52. Primary and safety analyses included patients who received at least one dose of the study drug. This study is registered on the EU Clinical Trial Register (EudraCT; 2014-005376-29) and is now completed. FINDINGS: Between July 10, 2015, and July 1, 2022, 86 patients with early Crohn's disease (45 [52·3%] female and 41 [47·7%] male) and 174 with late Crohn's disease (111 [63·8%] female and 63 [36·2%] male) were enrolled. Clinical and endoscopic remission at both week 26 and 52 was achieved in 27 (31·4%) of 86 patients with early Crohn's disease versus 15 (8·6%) of 174 patients with late Crohn's disease (difference 22·8%, 95% CI 12·6-33·7). Serious adverse events occurred in three (3·5%) of 86 patients with early Crohn's disease versus 46 (26·4%) of 174 patients with late Crohn's disease and included infections (one [1·2%] vs 13 [7·5%]), surgery (none vs eight [4·6%]), intestinal obstruction (none vs four [2·3%]), exacerbation of Crohn's disease (one [1·2%] vs six [3·4%]), and malignancy (none vs three [1·7%]). INTERPRETATION: Vedolizumab treatment is safer and more effective in early than in late Crohn's disease. Vedolizumab could be considered as a favourable treatment option for patients with biologic-naive Crohn's disease with a short disease duration. FUNDING: Takeda Nederland.