What to Expect From Your Medicine

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Our goal when we treat patients with ulcerative colitis is to really get them back to a state of health where they were before they ever developed ulcerative colitis. We have medicines now that truly can get a patient completely well. And so to set expectations that we can realistically achieve that goal is important when we meet patients.

Unfortunately, we don't have a cure yet, although I think we will have one in our lifetime. Really what we're shooting for is for you to be in complete remission, meaning that when we ask you about your symptoms, you're not having any symptoms at all. And when we look at the lining of your colon, it has gone back to normal. We call that a deep remission, and that is achievable in most patients.

When we meet a patient who has a newly diagnosed ulcerative colitis, in the past we used to try to match the treatment with the severity of their disease currently. So in other words, if someone had really severe symptoms, meaning they had more than six stools per day, maybe some blood in their stool, we would be thinking about prednisone and aminosalicylates. Now what we really try to do is look into our crystal ball and predict, based on some of the clinical and demographic features and also endoscopic features, what the future course of that patient's disease is going to be.

So a patient can present initially with somewhat mild disease, mild-to-moderate disease, but when we look at some of the factors such as their age, the appearance on endoscopy, how much of their colon's involved, we really realize that that patient is likely going to have more of an aggressive disease course. And so we tailor the treatment recommendations at that point more to what we feel their future risk of colectomy might be.

If there's a patient that presents with very mild disease, maybe they're having three or four stools per day without any blood, and when we look in their colon, they have very mild inflammation, that patient also has a low risk of disease progression. So in that patient, we might start an aminosalicylate [INAUDIBLE] they're packaged differently to deliver medicines in different parts of the intestines, either the small intestine or the colon, and the goal of those medicines is to topically coat the colon with an aminosalicylate, an antiinflammatory medication to calm down the inflammation that's there. It doesn't work systemically at all, and very little of it is absorbed into the bloodstream. If a patient has disease which is more moderate, then we might be thinking about some of our other agents in the next one. To treat an acute flare, it would be something like prednisone, a corticosteroid.

Corticosteroid works by shutting down the immune system more globally. It suppresses the immune system globally to reduce the inflammation in the colon that's causing the flare. The problem with steroids is that there are a lot of long-term side effects, and so it's really only used to treat the acute flare and should not be used for maintenance therapy.

There is a different type of steroid, which is packaged either to release in the small intestine or in the colon, and it works also topically, mainly, to calm down the inflammation that's there, and very little of it is absorbed systemically. So you get some of the benefits of prednisone without most of the side effects of prednisone, so it's a nice option for patients with refractory mild disease or moderate disease that are not responding to the aminosalicylates.

Now, when you have someone that has more moderate-to-severe or severe disease and/or they have risks of disease progression like we talked about, then we're thinking about using our biologic agents or our immunomodulators. So let's start with the immunomodulators, and essentially, these work slightly differently, but the end result is they suppress the bone marrow to reduce excess inflammatory cell production, and thus reduce the inflammation within the colon. The reason that these are not used for treating acute flares is that they take a while to work, usually two to three months.

And so-- well, you normally use these either as a maintenance medication after a bridge such as prednisone or to help our other agents, our biologics, which we'll talk about next, work more effectively or reduce the risk of antibodies to developing against those biologics.

Those work by shutting off or reducing that pro-inflammatory signal called tumor necrosis factor. These work globally, and also get rid of the cells that produce those cytokines, and thus reduce the inflammation fairly quickly. We expect these medications to begin to work within about two to four weeks. They are one of our more effective agents and are used both for induction of remission and for maintenance of remission if the patient responds. When we start patients on these medications, we expect or hope that patients will get better clinically, their symptoms will be improved very quickly.

But it's also important to know that their colon, the lining of their colon mucosa has gone back to normal. And so it's very routine now to repeat a colonoscopy usually after about six months of being on these agents to document what we call mucosal [INAUDIBLE]. In other words, we've restored the lining of the colon back to normal.

We know when we achieve that, we have much better outcomes, less hospitalizations, less need for surgery, so it's an important thing to have on your radar when starting any of these medications for treatment with ulcerative colitis.