Vedolizumab better used in early- vs late-stage Crohn’s disease

In patients with Crohn’s disease (CD), initiating treatment with vedolizumab early than late in the disease course may lead to better safety and efficacy outcomes, according to a phase IV open-label cohort study.

The study included 260 adult patients with moderate to severe CD (Crohn’s Disease Activity Index [CDAI] 220–450, with ulcers at endoscopy). Of these, 52.3 percent had early CD (diagnosis established less than 2 years ago and naïve to advanced treatment) and 63.8 percent had late CD (diagnosis made more than 2 years ago and previously treated with corticosteroids, immunomodulators, and anti-TNF agents).

All patients received intravenous vedolizumab 300 mg at weeks 0, 2, and 6, and every 8 weeks thereafter for 52 weeks. An additional 300-mg infusion was administered at week 10 in patients who did not achieve a decrease in CDAI of more than 70 at week 6. Colonoscopies with biopsies were performed at screening and at weeks 26 and 52, with the results assessed by masked independent readers using the Simple Endoscopic Score for Crohn's disease (SES-CD).

The primary endpoint of clinical and endoscopic remission (defined as CDAI ≤150 and SES-CD <4) at both week 26 and 52 occurred in 31.4 percent of patients with early CD vs only 8.6 percent of those with late CD (difference, 22.8 percent, 95 percent confidence interval [CI], 12.6–33.7).

Serious adverse events were documented in 3.5 percent of patients with early CD vs 26.4 percent of those with late CD. These events included infections (1.2 percent vs 7.5 percent), surgery (none vs 4.6 percent), intestinal obstruction (none vs 2.3 percent), exacerbation of CD (1.2 percent vs 3.4 percent), and malignancy (none vs 1.7 percent).

These findings suggest that vedolizumab may be a favourable treatment option for patients with biologic-naïve CD with a short disease duration.