Takeda Pharmaceutical Company Limited announced that the company is presenting data on the real-world effectiveness and safety of vedolizumab in patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) during the United European Gastroenterology (UEG) Week in Vienna, Austria, October 16 to 19, 2016. Findings indicated notable clinical remission rates, reductions in disease activity scores and improved mucosal healing in more than 5,000 patients with UC and CD receiving treatment with vedolizumab in real-world clinical practice.

Real-world data are information reported and collected from use of a medication in uncontrolled clinical settings. A systematic review identified 51 reports of real-world studies of vedolizumab. The poster presentation entitled ‘Systematic literature review of real-world effectiveness and safety of vedolizumab in adult UC and CD patients’ included 51 independent cohorts published up to April 2016 describing 5,775 patients treated with vedolizumab, the majority of whom were refractory to prior anti-tumor necrosis factor (TNF) therapies. Clinical remission at week 14, measured across a range of definitions, was in the range of 24–55 per cent in patients with UC (6 studies) and from 14–38 per cent in patients with CD (7 studies). Safety data are consistent with previous vedolizumab clinical trial results in patients with moderately to severely active UC or CD.

“Given that ulcerative colitis and Crohn’s are chronic diseases affecting more than 5 million people worldwide, it is important that we evaluate a treatment’s effectiveness and safety in real-world practice to assess benefit for patients from vedolizumab. These data further support the use of vedolizumab and should give physicians confidence in vedolizumab for both biologic naïve and TNF experienced patients,” said Stefan Schrieber, MD, Translational Inflammation Research, Christian Albrechts University, Kiel, Germany.

Comparative real-world data with infliximab were also presented at the congress, highlighting key treatment outcomes that are important for patients. Findings from a matched, multi-center retrospective cohort study suggested that patients with moderately to severely active UC or CD receiving biologic treatments for the first time treated with vedolizumab were less frequently hospitalized, compared to those receiving infliximab (mean number of IBD-related hospitalizations: 0.11 vedolizumab vs 0.29 infliximab; P=0.048) and may be less likely to discontinue their treatment (HR: 0.86 [95 per cent CI: 0.63, 1.16]).

Further findings from a US health records database also showed that patients with UC or CD treated with vedolizumab were less likely to experience an increase in dosage compared to those treated with infliximab during the first 6 months of treatment (4 per cent vedolizumab vs. 21.5 per cent infliximab; P<0.05).4 This could, in part, reflect the guidance in the US label to increase the dose for patients with CD treated with infliximab who initially respond and then lose response. It is important for treating physicians to consider the impact of dose escalation on patients’ quality of life and health economics in the management of chronic inflammatory conditions such as UC and CD.

“With vedolizumab now approved in more than 50 countries in addition to more than 50,000 patient-years of clinical experience, the real-world data on vedolizumab presented at UEG Week continue to support and build physician confidence in its effectiveness in the management of ulcerative colitis and Crohn’s disease,” said Sharon O'Byrne, MD, vice president, global medical head, Specialty GI, Takeda Pharmaceuticals.

Ulcerative colitis (UC) and Crohn’s disease (CD) are marked by inflammation in the GI tract. UC impacts the large intestine only, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. CD can impact any part of the digestive tract and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. There is no known cause for UC or CD, although many researchers believe that the interaction between genes, the body’s immune system, and environmental factors play a role. The aim of UC and CD treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.

Vedolizumab, developed for the treatment of UC and CD, is a humanized monoclonal antibody that is designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1) and fibronectin, but not vascular cell adhesion molecule 1 (VCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.9 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in UC and CD. 8,10 By inhibiting alpha4beta7, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.

Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFa) antagonist.

Vedolizumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFa) antagonist.