Subcutaneous vedolizumab in moderately to severely active ulcerative colitis or Crohn’s disease: a profile of its use

Abstract

Vedolizumab (Entyvio^®), a humanized monoclonal antibody targeting the α4β7 integrin, is effective and generally well tolerated as an induction and maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor (TNF)-α antagonist. Initially approved as a lyophilised powder for reconstitution and administration via intravenous infusion, more recently, a solution for subcutaneous injection has been developed (and approved in various countries, including those of the EU, for these patient populations) to provide patients, caregivers and healthcare providers with an alternative route of administration for vedolizumab maintenance treatment, potentially providing convenience benefits. In clinical studies in these UC and CD patient populations, subcutaneous vedolizumab as a maintenance therapy improved clinical remission rates and health-related quality of life (HR-QOL) relative to placebo over 52 weeks, with clinical benefits maintained for up to 2 years in the UC patient population. Its safety profile did not differ to a clinically relevant extent from that seen with intravenous vedolizumab, although, as expected, injection-site reactions (mostly erythema and pruritus) were more frequently reported with subcutaneous administration. Thus, subcutaneous vedolizumab extends the options available for the maintenance treatment of adults with moderately to severely active UC and CD.

Plain Language Summary

Ulcerative colitis (UC) and Crohn’s disease (CD) are types of inflammatory bowel disease. The aim of treatment is to stop the inflammation and prevent further flare-ups. Among the treatment options is the biologic vedolizumab (Entyvio^®). Initially available for controlled administration into the bloodstream, a version of vedolizumab for subcutaneous injection once every 2 weeks has recently been developed. In adults with moderately to severely active UC or CD who initially responded to intravenous vedolizumab, the use of subcutaneous vedolizumab for 1 year induced and maintained remission, and improved quality of life. These benefits were maintained for up to 2 years in the UC patient population. The safety of subcutaneous vedolizumab is similar to that of intravenous vedolizumab, although, as expected, injection-site reactions (mostly redness and itch) were more frequently reported with subcutaneous administration. Thus, subcutaneous vedolizumab extends the options available for the maintenance treatment of adults with moderately to severely active UC and CD.