Subcutaneous HS Therapy: Efficacy and Safety Insights

In the continuation of our discussion with Chris Sayed, MD, dermatologist and professor in the Department of Dermatology at the University of North Carolina at Chapel Hill, about the November 20 approval of bimekizumab for moderate to severe hidradenitis suppurativa (HS), he discusses the benefits of subcutaneous treatment of the chronic inflammatory skin condition.

Click to revisit part 1 of our interview in which Sayed discusses the BE HEARD I and II trial data, which served as the basis of the FDA’s approval, and how this dual IL-17A/IL-17F inhibitor addresses treatment gaps for these patients.

This transcript has been lightly edited for clarity.

Transcript

How does subcutaneous treatment for HS compare with topical options?

Topical options and subcutaneous options come in different varieties now, where we have different options for HS patients. There’s no FDA-approved topical option. Topical options can sometimes be helpful when it comes to topical antibiotics and antiseptics and things like that. I would say they are modestly effective at best and typically just in patients with relatively mild disease. I think it's relatively rare for them to be a game changer, especially in patients who have more advanced disease with scarring and tunneling.So we often add them on on top of other things that are given as either pills or injections, but by themselves, they leave much to be desired. I think we need the trials to look at novel topical therapies that have robust responses enough that we can measure them and feel confident using them and that they're actually going to make a difference.

Most subcutaneous therapies, oral therapies are going to be that works from the inside out, which is what you need in HS. It's often a very severe chronic inflammatory condition with effects beyond just the skin. And so I think they tend to be more effective and probably have a more long-lasting impact for patients for the most part.

The benefit of topicals is that they're going to be very safe. There's going to be a low risk of side effects. It's just that you really give up a lot when it comes to efficacy on average.

What are some adverse effects of subcutaneous treatment of HS?

Every medication has potential for side effects and that includes any of the drugs right now that are approved for HS. We know that they all have some effect on the immune system, and so there's always concern about a slight increased risk of certain kinds of infections.Like if you have TB [tuberculosis] that's resting in your lungs, it's a little bit more likely to wake up. Fortunately, that's a pretty unusual scenario in the U S and we screen for and can watch for it and make sure those things don't happen for the most part or that we quickly react when they do.

For the most part, patients tolerate the medications pretty well.I tell patients all the time, the goal of a medication is to make life better, and if you're getting a side effect that means it's not making life better, I am not going to keep you on that medication.You're going to stop it and do something else. Generally, patients feel like their skin feels better. Hopefully symptoms like fatigue, quality of life, mental health improvement as their symptoms are better controlled.And those are all usually like great trade-offs when it comes to considering the relatively low chance of risks for most of these drugs.

When we specifically think about immunomodulators, or the types of drugs like this that are approved right now, that there are things like rashes that can sometimes happen that patients are looking out for, but they're not overly common and it's a quick thing that we can adjust for and either treat or change the medication if we need to.

Bimekizumab has things like low rates of yeast infections that can affect the mouth or thrush, but those were things that pretty much no patients ever wanted to stop the medication for in the trials. And they were all able to continue because they were minor types of things that are very easily treated and are a minor nuisance compared to something as terrible as HS. So I tell most patients though, yeah, while there are trade-offs, those trade-offs almost always go in favor of, you're going to want to stay on that medication, and then if you're not feeling that way after a few months, it's not a permanent thing.

I would also say that there are protective effects for medications like this. I think about the risk of not treating HS and the toll that takes on the body—not just on the skin, but internally, too. We know that there's extra cardiovascular risk associated with having chronic inflammatory diseases. So high rates of things like heart attack and stroke over time.And there are pretty clear indications from lots of inflammatory diseases that the more carefully you control those things or you control the underlying condition, the more you probably reduce some of those long-term risks also.

I think it's a positive trade in both quality of life that people get—they hopefully live better with less disease impact—and probably also we protect them from some of those things that are really dangerous and more common. I worry a lot more about cardiovascular risks for patients than I worry about the chance of something like tuberculosis reactivating in the United States. So I think it's very much in favor of controlling the disease and stemming all of the problems that come from the disease, much more than medications typically.