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Vedolizumab Is Effective for Induction and Maintenance in IBD

Summary and Comment |
August 21, 2013

Vedolizumab Is Effective for Induction and Maintenance in IBD

  1. Douglas K. Rex, MD

Induction response was higher in ulcerative colitis than in Crohn disease, but maintenance of remission in both was around 40% at 1 year.

  1. Douglas K. Rex, MD

Phase II studies suggest that vedolizumab, a monoclonal antibody, might be effective in inflammatory bowel disease (IBD). It could also present an alternative to natalizumab, which is associated with progressive multifocal leukoencephalopathy, a devastating brain infection.

In two separate but similarly designed industry-supported, phase III trials, investigators randomized patients with ulcerative colitis (UC) and Crohn disease (CD) to receive 300 mg of intravenous vedolizumab or placebo at weeks 0 and 2. A separate large group of patients was treated with open-label vedolizumab, and those who responded were randomized to maintenance therapy with vedolizumab at 4-week or 8-week intervals or placebo.

Results of the UC trial included:

  • Induction of clinical remission at week 6 was higher with vedolizumab than with placebo (47.1% vs. 25.5%).

  • Maintenance of clinical remission at week 52 with vedolizumab was similar with 4-week and 8-week doses (41.8% and 44.8%) and higher than with placebo (15.9%).

  • Numbers needed to treat (NNTs) for inducing and maintaining remission were 4.6 and approximately 3, respectively.

Results of the CD trial included:

  • Induction of clinical remission at week 6 was higher with vedolizumab than with placebo (14.5% vs. 6.8%).

  • Maintenance at week 52 with vedolizumab at 4-week and 8-week intervals (39.0% and 36.4%) was higher than with placebo (21.6%).

  • The overall rate of serious adverse events was higher with vedolizumab than with placebo (24.4% vs. 15.3%).

  • Nasopharyngitis, infections, and serious infections occurred more frequently with vedolizumab than with placebo.

  • NNTs for inducing and maintaining remission were 13 and approximately 6, respectively.

Comment

Vedolizumab will be a new, effective option for induction and maintenance therapy in inflammatory bowel disease, particularly ulcerative colitis. One caveat in interpreting the numbers needed to treat is that clinical disease activity was measured with different scales for the two diseases. The real news here: Unlike natalizumab, this drug does not increase the risk for terrifying brain infections.

  • Disclosures for Douglas K. Rex, MD at time of publication Consultant / Advisory board Exact Sciences; Ferring Pharmaceuticals; Given Imaging; Olympus Speaker’s bureau Boston Scientific; Braintree; Ferring Pharmaceuticals Grant / research support Battelle; Braintree; Northwestern University; Olympus America Editorial boards Annals of Gastroenterology and Hepatology; Comparative Effectiveness Research; Expert Review of Gastroenterology and Hepatology; Gastroenterology; Gastroenterology and Hepatology News; Gastroenterology Report; Gastroenterology Research and Practice; Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; World Journal of Gastroenterology; World Journal of Gastrointestinal Oncology; World Journal of Gastrointestinal Pathophysiology; World Journal of Gastrointestinal Pharmacology and Therapeutics

Citation(s):

Reader Comments (1)

Edward Abraham Physician, Critical Care Medicine

For these summaries, it would be very helpful to provide the target for vedolizumab and a suggested mechanism of action.

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