With the recent FDA approval, ustekinumab could be the first choice to treat ulcerative colitis.
While ustekinumab has been used since 2016 to treat Crohn’s disease, the US Food and Drug Administration (FDA) recently approved the drug for ulcerative colitis.
A number of studies presented at the American College of Gastroenterology’s Annual Scientific Meeting (ACG 2019) focused on ustekinumab, including the UNIFI study that showed the medication is safe and effective in treating ulcerative colitis.
In an interview with MD Magazine®, Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami Health Center, said the UNIFI study shows the promising future of ustekinumab.
MD Magazine: What is the main take home from the UNIFI study?
Abreu: It shows that it's effective. I think ustekinumab is very effective in Crohn's and ulcerative colitis. They found that even at 8 weeks, there was evidence of response, which is a very gratifying thing to see.
They also importantly set another standard which is that they have shown us that even though it's a small percentage of patients, that patients on ustekinumab not only achieved endoscopic healing but also histologic healing.
So really both because it not only looked good but even under the microscope it was healed. So that's going to set a very high bar, admittedly in a small percentage of patients.
I suspect that in real practice when we tweak dosing when we wait longer that we'll have a higher proportion of patients respond.
Moreover, I think all of our modern-day biologic studies are plagued by the fact that these are patients by the time they get into clinical trials have had the disease for a long time and have been on other medications.
I want to say maybe 20% or a little less than 20% of patients had been both on anti-TNFs previously as well as vedolizumab. So already these are patients that are the most refractory, they've been on more than one mechanism of action before they got into the UNIFI studies.
There I want to say maybe 50% of the patients were on previous anti-TNF therapy. These are people who have been previously biologic exposed and that group doesn't seem to do as well on anything.
They still do better than placebo when they get the drug, but the overall rate of response is lower than it is for people who are naive to therapy. I think that ustekinumab is a very safe drug that's again shown in this particular study that was very safe.
MD Mag: Do you believe that ustekinumab will be a first line treatment for ulcerative colitis?
Abreu: With respect to ustekinumab being the first line of therapy, I think it's very safe. I think that I would use it as first line if I could.
My hope is that the fact that it's already been around for Crohn's disease, the fact that it's around for psoriasis, makes it available for more people.
Maybe it'll bring that cost down so that we could use it as a first-line therapy. When I say first line I should say first line biologic therapy. Obviously in the space of ulcerative colitis, mesalamine can be very effective so we should use those as first-line, but I think ustekinumab is very effective.
Earlier at this meeting, a physician came to ask me about a patient who's being treated with chemotherapy for another cancer but has a very active Crohn's disease. I think that ustekinumab is safe in that setting so I do use it.
I think it's safe even in older people. That's a big deal because we're seeing that our patient population is getting older and interestingly still has quite active disease.
I feel like 1 of the things that's changing in terms of the natural histories we're now seeing older people who have had Crohn's or ulcerative colitis for a long time and yet the disease is not going into remission just because of age.