A new monoclonal antibody has been licensed for IBD, says Uchu Meade, a pharmacist specialising in gastroenterology.

NICE has approved vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), who have had an inadequate response with, lost response to, or were intolerant of either conventional therapy or a TNF-alpha antagonist (see NICE technical appraisals 342 and 352).

Vedolizumab has a different mode of action to other conventional therapies. A humanised monoclonal antibody, it exclusively binds to α4β7 integrin that is expressed on T-lymphocytes. These T-lymphocytes specifically combat the immune system in the gut.

Vedolizumab aims to block the interaction between α4β7 lymphocytes and mucosal addressin cell adhesion molecule-1 (MAdCAM-1), located on the endothelial cells of the gut, and so disrupt trafficking of T-lymphocytes into the inflamed gut. As there is a possible risk of opportunistic infections and/or infections that are normally prevented by the immune system of the gut, patients should be monitored closely before, during and after treatment.

Live and oral vaccines should be used with caution. Nasopharyngitis and arthralgia are listed as very common (≥1/10) side-effects in the SPC.

Induction dosing

Induction dosing is a 300mg intravenous infusion over 30 minutes at week 0, repeated at two weeks, then at six weeks, followed by eight-weekly maintenance therapy. The exact elimination route of vedolizumab is not known. Dose reduction in renal and/ or hepatatic impairment is currently not recommended.

Example case history

Miss A was diagnosed with CD in 2006. Initially, she was tried on an enteral diet for six weeks but this was unsuccessful. Since diagnosis, she has used multiple courses of oral and intravenous corticosteroids and, at one stage, was dependent on corticosteroids to control her symptoms. As a side-effect she has developed osteoporosis.

In 2007, when she was started on azathioprine, her disease was found to be refractory despite optimised dosing and therapy duration. Infliximab was then started but she had an allergic reaction during the infusion.

In late 2007 to 2010, adalimumab was started. Miss A was a primary responder but then lost response. She also developed tuberculosis.

She is considered to have severe early onset CD requiring surgical intervention. Her first surgical resection was in 2006 for fistulating small bowel CD and her last resection was in 2010. She also underwent proctocolectomy and is currently dependent on parental nutrition (PN) due to short gut syndrome as a result of several bowel operations.

The patient’s symptoms remain uncontrolled. A decision was made to start vedolizumab as monotherapy. She will be given induction infusions and her response will be gauged at 12 weeks. If the treatment is of benefit, it will be continued for one year and then reassessed.