Crohn's Disease: Clinical Experience With Ustekinumab


Bruce E. Sands, MD: My experience using ustekinumab in my patients with Crohn’s disease has been really quite good. These are patients who have had a high clinical need. Often, they’re patients who have been through 1 or more TNF blockers and are no longer responding to those medications. Often, they’ve been through immune modulators. Some of them have also had treatment with vedolizumab and are no longer responding to that medication. And even in these situations, I’ve seen patients respond and remit over time. So, it gives a whole new mode of treatment to a very needy population. I’ve also treated some patients who have not been through the routes of other biologic treatments, and they actually respond very well too.

The safety profile of ustekinumab really appears to be quite excellent. Whereas, with the TNF blockers, we know about the black box warnings regarding lymphoma. We know about the risks of serious infections. Ustekinumab is an agent for which we have about 4 years of experience in the psoriasis population and a whole year on the market with a Crohn’s disease indication. The clinical trials, as well as the clinical experience, would indicate that this is a very safe agent. We are not seeing high risks of infections or unusual infections. We don’t expect to see that. We’re not aware of any risk of lymphoma with this agent, so, overall, it seems to have a superior safety profile. The other thing that I would add is that it seems to be effective as a monotherapy, whereas we’ve talked quite a bit about anti-TNF therapy in combination with an immune modulator. We don’t see high rates of anti-drug antibodies with ustekinumab, at least with the way that we’re dosing this drug in Crohn’s disease, which makes it very attractive for patients and physicians alike.

William J. Sandborn, MD: I’m sometimes asked, what’s my personal experience with using ustekinumab in Crohn’s disease? I found it to be useful in a variety of settings. It interestingly doesn’t have any black box warnings around infection or malignancy. So, if you have patients for whom you’re worried about the potential of side effects in those arenas, ustekinumab can be a good choice. The intravenous dosing at the front end, I think, works quickly and is well dosed. So, we find that sick patients and that IV dosing can be quite useful. There’s evolving experience with fistulas, with seeing colonoscopy healing. If there are skin extraintestinal manifestations such as pyoderma gangrenosum, or both autoimmune psoriasis and drug-induced psoriasis from anti-TNF drugs, ustekinumab seems to work really well for those dermatologic conditions, as well as the mainstays of the indication for Crohn’s disease in inducing and maintaining remission and steroid sparing.

Bruce E. Sands, MD: I think in the future we’re going to see much broader use for ustekinumab, whereas right now we’re often treating patients who are refractory to TNF blockers. It’s very clear that this drug is also effective in patients who are biologic naïve. Because of its superior safety profile, I think that we’re going to see this drug used earlier in the course of disease and in patients who have not had the experience of a lot of other agents. I’m also very impressed by the durability of response, and so I think we’re going to see patients staying on this drug for long periods of time to maintain their remission. I think we’ll see that come, and I think we’ll also see exploration of its efficacy in ulcerative colitis. There are clinical trials that are ongoing. We don’t have the results yet, but the genetics would suggest that this agent should work in ulcerative colitis as well.

William J. Sandborn, MD: It’s interesting to think ahead to the future of ustekinumab. One of the questions that we have, if you’re thinking of it as a first-line biologic, is how would it compare head-to-head to anti-TNF drugs like infliximab or adalimumab? Would it be similarly effective in patients who are anti-TNF naïve, or would it be superior? The signal in the anti-TNF population for efficacy was quite strong, and it’s possible that it could be superior. So, head-to-head trials will be done, and those are very interesting to think about. It’s also been tested for ulcerative colitis, and we’re expecting to see the data come out on that over the next 6 months or so. And that could be a whole other frontier for ustekinumab, depending on how those clinical trials turn out.

Transcript edited for clarity.

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