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

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Version 3 2021-10-11, 23:09
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posted on 2021-10-11, 23:09 authored by Sheridan M. Hoy
Funding The preparation of this review was not supported by any external funding.

Authorship and conflicts of interest Sheridan M. Hoy is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

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.

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