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New data from the American College of Gastroenterology (ACG) 2020 conference have 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 randomized placebo-controlled trials GEMINI, has shown that the humanized, anti-α selective intestinal drug4b7 integrin, the monoclonal antibody is associated with clinical remission without corticosteroids. However, there have been limited data demonstrating these same results in real clinical settings.
A team led by Caroline Shaw, PhD, of PHMR, London, conducted a systematic literature review of real-world studies of vedolizumab published from January 2014 to October 2018. They did so using the MEDLINE and EMBASE databases, as well as lecture abstracts .
Reports with <50 patients, patients <18 years of age or who evaluated vedolizumab off-label were excluded.
The researchers performed a meta-analysis using the DerSimonian-Laird random effects model. Therefore, 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), which reported a corticosteroid-free clinical response and remission in patients treated with vedolizumab.
For most of these studies, clinical corticosteroid-free response for ulcerative colitis was defined as a complete gradual reduction in corticosteroid use and a reduction in partial Mayo score of ≥3. For Crohn’s disease, response was typically defined as no oral corticosteroid dosage and a reduction in the Harvey-Bradshaw index of ≥3.
A total of 1544 patients with ulcerative colitis and 2748 patients with Chron’s disease were evaluated in this study. In the ulcerative colitis population, the weighted mean age was 41.5 years. The population-weighted mean age of Chron’s disease was 40.6 years.
Also, 54.5% and 41.8% of ulcerative colitis and Chron’s disease, respectively, were male. Disease duration was 8.0 years for ulcerative colitis and 13.3 years for Chron’s disease.
Finally, most patients in both disease groups had received anticancer necrosis factor therapy.
The researchers then found that for both conditions, the early clinical response without corticosteroids 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 by a response rate of 28.4% (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.
In addition, they noted that corticosteroid-free clinical remission for ulcerative colitis patients at 12 months (46.8%) was greater than for 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%).
Therefore, Shaw and the team concluded that this pooled analysis provided real-world support and evidence that vedolizumab is effective as a long-term maintenance treatment against such inflammatory bowel diseases.
“These results should be interpreted in the context of the heterogeneity observed in 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.
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