During the ACG meeting, investigators tested a subcutaneous form of vedolizumab to treat ulcerative colitis.
Vedolizumab is already approved to treat ulcerative colitis in an intravenous formulation, but investigators are now testing it in a subcutaneous form in the VISIBLE study.
During the American College of Gastroenterology’s Annual Scientific Meeting (ACG 2019), Douglas Wolf, Director of IBD Research for Atlanta Gastroenterology Associates, explained in an interview with MD Magazine® how the new formulation of the drug could be particularly beneficial for this patient population.
MD Magazine: What was the impetus of the VISIBLE program?
Wolf: A new formulation of ENTYVIO (vedolizumab) was developed so that patients would have the option to take ENTYVIO long term as subcutaneous treatment and self-administrator or continue with the already established intravenous formulation.
That requires dosing in an infusion unit or hospital or some treatment units or in an office infusion unit. Something like that.
So, the development of this new subcutaneous formulation really gives patients great options with long-term treatment within ENTYVIO to self-administer and dose at home.
MD Magazine: What is the next step in this study?
Wolf: So, this is really a post-hoc analysis of long-term extension data. This is often done and so every year or so over 5 years there will be an examination of the data.
There will be data cuts, but this study is intended to go out 5 years. The biological license application to the FDA has already been submitted and things are in the works for approval of subcutaneous ENTYVIO.
That approval is anticipated in in 2020. It may be early in 2020, it may be in the middle of 2020, it's not absolutely unknown.
It could be early and then there are going to be different transitions that patients have the option to proceed with going from their current IV formulation to subcutaneous. Or new starts, who go
on IV ENTYVIO, they may plan to transition or anticipate to transition as early as week 6.
MD Magazine: How hopeful are you that vedolizumab subcutaneous will be a viable ulcerative colitis treatment?
Wolf: I think the data that we have so far indicates that we can transition in several different ways. In practice, it's going to be transitioning likely in even more ways.
It looks like all of them work. The pharmacokinetics of this new formulation is favorable. When I say favorable, the blood levels are higher than the blood levels for the approved every 8 week IV formulation.
So, it looks good, it looks like something that works as a practical transition pharmacokineticly as well as convenience wise for many, many patients.
Certainly, for the majority of patients who are taking ENTYVIO it looks like a slam dunk and it may work for all.
It certainly looks very practical for the majority of patients and then it's just that sort of shared decision-making with patients you want to have IV infusions long-term or do you want subcutaneous infusions. Whatever works out best for that individual.