According to phase 4 trial results, vedolizumab is safer and more effective as a treatment in early Crohn’s disease, compared to late Crohn’s disease.
This open-label, investigator-initiated, phase 4 cohort study enrolled 260 patients with moderate to severe Crohn’s disease. There were 86 patients with early disease, defined as having a diagnosis less than 2 years ago and no exposure to advanced treatment, and 174 with late disease, defined as having a diagnosis more than 2 years ago and received previous treatment with corticosteroids, immunomodulators, and anti-tumor necrosis factor (TNF) agents. All patients received 300 mg vedolizumab intravenously at weeks 0, 2, and 6, and every 8 weeks after for up to 52 weeks. Patients who did not experience a decrease in CDAI of more than 70 points at week 6 received an additional infusion of 300 mg vedolizumab at week 10. Colonoscopies with biopsy were performed at screening, at week 26, and at week 52. The primary end point of this study was the proportion of patients with clinical and endoscopic remission at both weeks 26 and 52.
There were 21.4% (27/86) patients in the early disease group and 8.6% (15/174) in the late disease group who achieved clinical and endoscopic remission at both weeks 26 and 52, for a difference of 12.8%. Serious adverse events occurred in 3.5% and 26.4% of patients, respectively. The most common serious adverse events included infections (1.2% vs 7.5%), surgery (0% vs 4.6%), intestinal obstruction (0% vs 2.3%), exacerbation of Crohn’s disease (1.2% vs 3.4%), and malignancy (0% vs 1.7%).