First Head-to-Head Trial of Entyvio vs Humira for UC
Last month, results from a head-to-head trial of Humira (adalimumab) versus Entyvio (vedolizumab) were presented in Copenhagen, Denmark at the 14th Congress of the European Crohn’s and Colitis Organization (ECCO). The results came from the VARSITY study, which was a Phase IIIb clinical trial that assessed the efficacy of Humira versus Entyvio for the treatment of moderate-to-severely active UC. Currently, Entyvio is on the market in the United States and throughout the EU for the treatment of both moderate-to-severely active Crohn’s disease and UC, which has not been responsive to treatment with conventional therapies or TNF-alpha antagonists (like Humira).
Comparing efficacy of treatments against one another
An increasing number of biologic medications, as well as other more conventional therapies, have been making their way to the market, however, few studies have been performed to compare the efficacy of these treatments against one another. The VARSITY study aimed to directly compare two commonly used biologic medications in order to help build knowledge on the benefits of different treatment options and provide more information on what options are best to use when. The trial took place across many sites and countries, and was a double-blind, randomized, active-controlled study. It also assessed the safety of Entyvio in comparison to Humira. Over 760 individuals with moderate-to-severely active UC, who had an intolerance or inadequate response to corticosteroids, immunomodulators, or other TNF-alpha antagonists (besides Humira) were involved in the trial. Half of the participants received Humira for 52 weeks, while the other half received Entyvio.
The primary endpoint of the study was clinical remission
At the end of the study, individuals taking Entyvio were more likely than those taking Humira to achieve clinical remission (which was the primary endpoint of the study). Specifically, 31.3% of individuals on Entyvio achieved clinical remission by week 52, while only 22.5% of those taking Humira reached this point. Additionally, the data surrounding the secondary endpoints of the study, including mucosal healing, were also interesting and may point toward Entyvio providing a greater benefit than Humira. Nearly 40% of those taking Entyvio demonstrated mucosal healing at the end of the study, while only 27.7% of those taking Humira experienced mucosal healing.
Those taking Humira were more likely to report experiencing corticosteroid-free remission at the end of the study, however, this difference was not large enough to be statistically significant. Overall, this suggests that Entyvio may provide stronger clinical benefits and greater rates of remission and mucosal healing at the one year mark, when compared to Humira.
Safety profile of the medications
The safety profile of Entyvio versus Humira favored Entyvio in the VARSITY trial, with 62.7% of individuals experiencing adverse side-effects to Entyvio, versus 69.2% on Humira. Similarly, fewer individuals on Entyvio experienced infections during treatment when compared to those on Humira (33.5% versus 43.5%). The frequency of serious adverse effects was similar in both groups, with individuals taking Entyvio experiencing serious side-effects about 11% of the time, while those on Humira had serious side-effects about 13.7% of the time. These results suggest that Entyvio may be safer and/or better tolerated at the one year mark when compared to Humira.
Entyvio is manufactured by Takeda Pharmaceutical Company, and is an alpha4beta7 integrin antagonist that acts specifically in the gastrointestinal tract. Entyvio’s mechanism of action is thought to help block inflammatory cells from infiltrating and taking action in the gut, which is what may lead to UC and Crohn’s-related symptoms. Humira is manufactured by AbbVie Inc., and is a TNF-alpha antagonist, which also plays a role in toning down the immune response and accompanying inflammation.1
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