Safety Profile of Topical Ruxolitinib in Atopic Dermatitis

Linda Stein Gold, MD: Talk to us about the safety profile with this new agent. We are in a new world now. What do we need to worry about? What can we expect?

Aaron Farberg, MD: This is topical ruxolitinib. As Peter A. Lio, MD, had mentioned, there is a boxed warning on JAK inhibitors; in particular, topical ruxolitinib. Many of the warnings that the FDA had put out for other oral JAK inhibitors were transferred to the entire class. We don’t have to be concerned about that. I am sure if we polled everyone who can confidently utilize it, they are not going to utilize it for a patient who has more than 20% BSA [body surface area]; 20% is enough that you have to start thinking about a systemic. Even if they did go beyond 20%, I am still OK with that. There are studies where they coated patients from the neck down for weeks and the absorption was still a mere fraction of what you get on the oral side. When it comes to safety, I am not really concerned. I am still reading into the adverse events, and I want to know what happened in those trials.

One of the things that was brought up was, what is going on when you put on this cream? Are you having any sort of reaction? It was less than 1%, which is very exciting because now we have a topical that patients can put on, and it actually feels really good. I have samples in the office. I’ll put it on the patient; they can feel it. This is a very unique topical that actually absorbs, and patients enjoy it. You can’t say that about a lot of other topicals, so I am very excited to have topical ruxolitinib in my armamentarium.

Linda Stein Gold, MD: When I first started out in practice I would say, “Here’s something for your sensitive areas, here’s something for those worse areas, here’s something you might prefer to use at night.” The patients were incapacitated by fear because they’d go home, they have multiple things in front of them, and you know they are going to reach for that potent steroid every single time. They think, “I’ve got it on my eyelids; well, it worked for my hands, so it’s going to work for my eyelids, why not?” Now we have what I like to call one-stop shopping. “Can I use it on my face?” Absolutely. “Should I use it on the sensitive creases?” Absolutely. “Can I put it in other areas?” Sure thing, go ahead and just keep it simple. Here’s one thing you can use at one time.

We’ve all talked about that box warning, and just to go into it more, we know this is a class label. The initial study came in a study that looked at a broader JAK inhibitor, which is tofacitinib, a more nonspecific JAK inhibitor. They did a postmarketing safety study in patients who have rheumatoid arthritis, in patients who are at higher risk aged 50 or over who had at least 1 risk factor for cardiovascular disease. What they found with this long-term study was that when they compared it with TNF [tumor necrosis factor] inhibitors, tofacitinib had a bit of a safety signal to it. That is where this box warning comes from. The label was then added to tofacitinib, it was then added to the other oral JAK inhibitors, and that continues with the topical JAK inhibitors.

Transcript edited for clarity