Vedolizumab shows therapeutic potential in ulcerative colitis, Crohn’s disease
Vedolizumab appears to be safe and effective in patients with ulcerative colitis (UC) or Crohn’s disease (CD), having been able to maintain steroid-free clinical remission in up to one-third of patients at week 54 with a reasonable safety profile, according to 1-year data from a prospective multicentre cohort study.
The study included 173 CD and 121 UC patients treated with vedolizumab induction therapy between June and December 2014. Overall, 272 completed the induction period and were evaluated at the week 14 visit (CD: n=161; UC: n=111). Disease activity was evaluated by the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC.
At week 54, the primary outcome of steroid-free clinical remission was reported in 27.2 percent in the CD group and in 40.5 percent in the UC group. The respective rates of sustained steroid-free clinical remission (from week 14 to 54) were 8.1 and 19.0 percent.
While no deaths were reported, severe adverse events occurred in 17 patients overall, including six that led to vedolizumab discontinuation.
The present data suggest that vedolizumab is able to maintain steroid-free clinical remission in a substantial proportion of patients, although a number of patients (especially those with CD) may experience loss of response during the first year of treatment.
Vedolizumab interacts with gut-selective trafficking leucocytes and prevents the infiltration of the gastrointestinal mucosa by circulating cells of the immune system. However, it has been speculated that the drug is more effective in UC patients than in CD patients. “Indeed, gut selectivity could be a disadvantage given the transmural nature of CD and its association with a higher systemic inflammatory burden,” researchers said. [N Engl J Med 2013;369:699-710; Gastroenterology 2014;147:618–627e3; Nat Rev Gastroenterol Hepatol 2010;7:15-29]
CD and UC are the two subtypes of inflammatory bowel disease characterized by chronic inflammation in the gastrointestinal tract. While safe and effective treatment options are available, a significant proportion of patients with moderate-to-severe CD or UC lack effective medical treatment. Moreover, the relatively effective immune suppressant and biologic therapy (or the combination of an immune suppressant and a TNF-α inhibitor) are associated with uncommon, but serious, side effects. [Immunotherapy 2012;4:883–898]