Real-World Data Show Vedolizumab (Entyvio) Maintenance Therapy Switch from Intravenous to Subcutaneous Formulation Is Safe and Does Not Compromise Efficacy in Inflammatory Bowel Disease
Feb 25, 2022 03:47
CST Updated
03:47
Takeda
Biopharmaceutical Manufacturer
Ulcerative Colitis (UC, Image Source: healthjade.com)
News on February 24, 2022 /BioValleyBIOON/ -- According to real-world data presented at the 17th Congress of the European Crohn's and Colitis Organisation (ECCO) on Inflammatory Bowel Disease (ECCO-IBD): Transitioning patients from Entyvio (generic name: vedolizumab), an intravenous (IV) formulation, to a subcutaneous (SC) injection formulation for maintenance treatment of inflammatory bowel disease (IBD) is safe and does not affect clinical outcomes.Entyvio is a gut-selective anti-inflammatory drug developed by Takeda Pharmaceutical Company Limited, which has been approved for the treatment of two common types of IBD: Ulcerative Colitis (UC) and Crohn's Disease (CD).
This study included all IBD patients treated at Oslo University Hospital who switched from Entyvio intravenous formulation to subcutaneous formulation for maintenance treatment of ulcerative colitis (UC, n=51) or Crohn's disease (CD, n=57). Patients were assessed at the first and fourth intravenous infusions, with continued evaluation for 3 months post-switch.
Three months later, 95.3% of patients remained on subcutaneous treatment. Four patients switched back to the intravenous formulation, and one patient switched to Stelara (ustekinumab). Injection site reactions occurred in 19 (17.6%) patients, with 12 (63.2%) experiencing repeated reactions.
In patients with ulcerative colitis (UC), 92% were in clinical remission at the time of the first injection, and 88% at the 3-month follow-up. In patients with Crohn's disease (CD), 72% were in clinical remission at the time of the first injection, increasing to 83% at the 3-month follow-up.
Before the switch, 25% of patients reported a preference for intravenous treatment, 28% reported a preference for subcutaneous treatment, and 47% were indifferent. Three months after the switch, 18% of patients reported a preference for intravenous treatment, 53% reported a preference for subcutaneous treatment, and 29% were indifferent to the route of administration.
MeetingReporter, Dr. Marte Lie H?ivik from Oslo University Hospital in Norway, stated: "Switching Entyvio from intravenous to subcutaneous administration is feasible and safe. During the 3-month follow-up after the switch, there were no changes in clinical remission rates, C-reactive protein levels, or fecal calprotectin. Additionally, patients' attitudes toward the route of administration changed after the switch. Current real-world data suggest that subcutaneous maintenance therapy with Entyvio is an attractive alternative to intravenous administration."
Entyvio is a gut-selective biologic, and its active ingredient vedolizumab is a fully humanized monoclonal antibody that specifically antagonizes α4β7 integrin, inhibiting the binding of α4β7 integrin to MAdCAM-1, a mucosal addressin cell adhesion molecule selectively expressed in the gastrointestinal vasculature and lymph nodes. α4β7 integrin is expressed on a subset of circulating white blood cells, which have been shown to play a key role in mediating the inflammatory process in CD and UC.
Entyvio intravenous (IV) formulation was approved for marketing in the U.S. and EU in May 2014, for the treatment of patients who have had an inadequate response to conventional therapy orTumorAdult patients with moderate to severe active ulcerative colitis (UC) and Crohn's disease (CD) who have had an inadequate response to tumor necrosis factor-alpha (TNFα) antagonists. Currently, Entyvio intravenous (IV) formulation is marketed in more than 70 countries worldwide. UC and CD are two of the most common types of inflammatory bowel disease (IBD).
In May 2020, Entyvio Subcutaneous (SC) formulation received approval from the European Commission (EC) as a maintenance therapy for the treatment of adult patients with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD). The Entyvio SC product line includes pre-filled syringes and pre-filled injection pens. Notably, Entyvio is the only approved maintenance therapy that offers both Intravenous (IV) and Subcutaneous (SC) formulations for adult patients with UC and CD, providing patients with more treatment options.
In China, Entyvio IV (Anjio, vedolizumab, injectable vedolizumab) was approved in March 2020 for adult patients with moderately to severely active UC and CD who have had an inadequate response, lost response, or intolerance to conventional therapy or TNFα inhibitors. Entyvio (Anjio?) was included in the first list of clinically urgent overseas new drugs and received expedited review.
Entyvio (Anjiyou) is currently the only gut-selective biologic in the field of inflammatory bowel disease (IBD). Clinical data show that it works quickly and achieves long-term clinical remission and mucosal healing, with good safety. It is a first-line biologic recommended by European and American international guidelines.
From the inclusion of Entyvio (Vedolizumab for Injection) in the first batch of clinically urgent overseas new drugs list to its rapid approval, this fully demonstrates the determination of the Chinese government to accelerate the introduction of innovative drugs and continuously improve the health of its people. The approval and market launch of this drug in China will provide a new treatment option for a large number of patients with moderate to severe IBD in China. (Bioon.com)