One in two with IBD respond to vedolizumab in 'real world' study

Last Updated: 2016-08-26

By Anne Harding

NEW YORK (Reuters Health) - Vedolizumab shows a "clear benefit" in controlling inflammatory bowel disease (IBD) and reducing steroid use, new findings show.

"We demonstrated that half of patients treated with vedolizumab would respond, so one in two respond, about one in three entered into remission, and one in four entered steroid-free remission, and those are all after 14 weeks of treatment," Dr. Mark Samaan of the IBD Centre at Guy's & St. Thomas' National Health Services Foundation Trust in London, the first author of the new study, told Reuters Health in a telephone interview.

Studies done in Germany, France and the US have had "remarkably similar" results, he added. "That's good evidence that this is a replicable result."

Vedolizumab selectively inhibits the migration of leukocytes to the gut, so it avoids the increased risk of serious infection associated with anti-tumor necrosis factor drugs, Dr. Samaan and his team note in their report, published online August 10 in Frontline Gastroenterology.

While the GEMINI 1 and GEMINI 2 trials demonstrated the effectiveness of the drug in ulcerative colitis (UC) and Crohn's disease (CD), respectively, the investigators looked at the drug's effectiveness in clinical practice by looking at data on 62 patients treated at two UK tertiary IBD centers from November 2014 to November 2015.

Median Harvey-Bradshaw Index (HBI) was 8 at baseline in the 27 CD patients; the maximum score is 11, not counting points added for the total number of liquid stools per day. The Simple Clinical Colitis Activity Index (SCCAI) was 6 (on a scale of 0 to 19) for the 23 UC patients. At 14 weeks, scores were 5 and 4, respectively. At week 30, data were available for 9 CD patients, with a median HBI 2, and 10 UC patients, whose median SCCAI was 2.

Seventy-four percent of patients had clinically active disease, and 59% of these patients had responded by week 14 and 38% had achieved remission.

Forty-eight percent of the patients were on steroids at baseline, while 32% were at week 14 and 16% were by week 30. "This observation is relevant to practice and should encourage clinicians to allow sufficient time before drawing conclusions regarding treatment success or failure," Dr. Samaan and his colleagues write. "Week 14 seems a reasonable, pragmatic and increasingly evidence-based time point to make this assessment."

SOURCE: http://bit.ly/2boUJ3w

Frontline Gastro 2016.