Vedolizumab Shows Real-World Efficacy Against Ulcerative Colitis, Crohn's Disease

Caroline Shaw, PhD

New data from the American College of Gastroenterology (ACG) 2020 conference has suggested that vedolizumab is a promising therapeutic agent for long-term maintenance treatment for patients with ulcerative colitis and Crohn’s disease.

Previous research, such as the GEMINI placebo-controlled randomized studies, has shown that the gut-selective, humanized, anti-α₄β₇ integrin, monoclonal antibody is associated with corticosteroid-free clinical remission. However, there has been limited data demonstrating these same results in real-world clinical settings.

A team led by Caroline Shaw, PhD, of PHMR, London, conducted a systematic literature review of vedolizumab real-world studies published from January 2014 – October 2018. They did this using MEDLINE and EMBASE databases as well as conference abstracts.

They excluded reports with <50 patients, patients <18 years old, or which assessed off-label vedolizumab.

The investigators performed a meta-analysis using the DerSimonian-Laird random-effects model. Thus, they generated weighted mean rates and corresponding 95% confidence intervals of corticosteroid-free clinical response and remission separately for ulcerative colitis and Crohn’s disease at 6 weeks, 10-14 weeks, 6 months, and 12 months.

Overall, their meta-analysis included 23 studies (18 for ulcerative colitis, 20 for Crohn’s disease), all of which reported corticosteroid-free clinical response and remission in patients treated with vedolizumab.

For most of these studies, corticosteroid-free clinical response for ulcerative colitis was defined as complete tapering off of corticosteroid use and a reduction in partial Mayo score of ≥3. For Crohn’s disease, response was typically defined as absence of oral corticosteroid dosing and reduction in Harvey-Bradshaw index of ≥3.

A total of 1544 ulcerative colitis patients and 2748 Chron’s disease patients were evaluated in this study. Of the ulcerative colitis population, the weighted mean age was 41.5 years. The weighted mean age for the Chron’s disease population was 40.6 years.

Additionally, 54.5% and 41.8% of the ulcerative colitis and Chron’s disease, respectively, were males. Disease duration was 8.0 years for ulcerative colitis and 13.3 years for Chron’s disease.

And finally, a majority of patients in both disease groups had received anti-tumor necrosis factor therapy.

The investigators thus found that for both conditions, early corticosteroid-free clinical response increased from 6 weeks to 10-14 weeks.

For example, at 10-14 weeks, the estimated pooled response rate was 64.3% (95% CI, 35.1-85.7) in the ulcerative colitis cohort and 68.2% (95% CI, 33.4-90.1) in the Crohn’s disease cohort.

For ulcerative colitis, this was an increase from 26.0% (only 1 study was included; no confidence interval was generated) at 6 weeks. As for Crohn’s disease, this increased from a 28.4% response rate (95% CI, 17.8-42.1).

Response was maintained at 12 months, with an estimated pooled rate of 58.4% (95% CI, 40.7-74.2) for ulcerative colitis and 51.0% (95% CI, 40.0-61.9) for Crohn’s disease.

Furthermore, they noted that corticosteroid-free clinical remission for ulcerative colitis patients at 12 months (46.8%) was higher than in GEMINI 1 (38.5%).

For patients with Crohn’s disease, clinical remission at 12 months (30.5%) was consistent with GEMINI 2 results (30.2%).

Thus, Shaw and team concluded that this pooled analysis provided support and real-world evidence that vedolizumab is effective as long-term maintenance treatment against such inflammatory bowel diseases.

“These findings should be interpreted in the context of heterogeneity observed across the studies in terms of patient characteristics and study sample size,” they wrote.

The study, “Vedolizumab Achieves Corticosteroid-Free Clinical Response and Remission in Inflammatory Bowel Disease: A Real World Meta-Analysis,” was published online by ACG.