In this feature video, Dr Christopher Bunick shared how his presentation at the 2023 Fall Clinical Conference tackles the critical topic of boxed warnings and their significance for dermatologists.

Christopher Bunick, MD, PhD, is an associate professor of dermatology and physician sciences at Yale University, in New Haven, CT.

Transcript:

Can you describe the main points your session will cover during the 2023 Fall Clinical conference?

Dr Christopher Bunick: Yeah, I am really excited about my upcoming talk at Fall Clinical. So the title of my talk is going to be Boxed Warnings. What do they really mean to you? And there are a few main points that I'm going to try to get across to all of the audience about boxed warnings.

First and foremost, what do boxed warnings mean?

Second, I'm going to walk through 10 myths, and I'm going to dispel those myths around boxed warnings. So there's going to be a top 10 myths and we're going to dispel them. Then we're going to look at FDA trends in applying boxed warnings, so we're going to cover that.

Then I'm going to talk a little bit about over the counter medicines because there's I think a misconception that all medicines with boxed warnings have to be prescription. That's not true.

Then we're going to talk about other drugs in dermatology besides JAK inhibitors that have boxed warnings because the last couple years, all the attention has been on the boxed warnings of JAK inhibitors. But in dermatology, I think that people may be surprised, we have a lot of other medicines that have boxed warnings. And then lastly, we will focus on JAK inhibitors and how things have changed over the last year or two as more efficacy and safety data has come out with regard to what that means about boxed warnings and how it impacts physicians and their prescribing habits of JAK inhibitors.

What are the latest updates boxed warnings physicians should be wary of particular when treating psoriasis, atopic dermatitis, and other inflammatory skin diseases?

Dr Christopher Bunick: I think that one of the most important things that's happened over the last year is there's been more long-term safety data that has come out with regard to oral JAK inhibitors, particularly in the atopic dermatitis space. So in particular, the longest safety data that I've seen is for Upadacitinib, where four year safety data has been very reassuring. There were no new safety signals for patients that have been on Upadacitinib for four years, there are extremely low rates of adverse events. But the adverse events of special interest that we're really concerned about, such as major adverse cardiac events, venous thromboembolism, or malignancy, the rates on the JAK inhibitors have actually been lower than baseline rates in the healthy US population, or healthy European populations, as well as the baseline rates in patients with AD that have moderate to severe AD.

So, when the rates of adverse events of JAK inhibitors are actually lower than these baseline rates of patients with atopic dermatitis untreated or the healthy population, you start to ask the question okay, well we have box warnings, there are certainly safety concerns that we have to watch for. But I think that what we're learning with the long-term safety data, particularly what we've seen with Upadacitinib, and there's comparable data for Abercitinib in adolescents, that the JAK inhibitors are proving safer than what the warnings would have suggested. This is good news for dermatology, and I'm going to dive into that in my talk at Fall Clinical.

How should physicians consider boxed warnings when treating their patients?

Dr Christopher Bunick: Well, I think first and foremost, if there is a boxed warning on a medication, you have to understand what it means. Why is it there? Where did it come from, and what does it mean in terms of how you manage the patient? I don't think boxed warnings necessarily should be ignored. And the goal of a boxed warning isn't to prevent you from using a medicine, it's supposed to guide you and help you use that medicine better for your patients. And so what I'm going to talk about in Fall Clinical are different ways in which dermatologists and healthcare providers can navigate those boxed warnings and what they mean.

So, for example, how do you do lab monitoring for patients that you're going to put on a JAK inhibitor, or even other types of boxed warnings for medications in dermatology? What are some of the lab monitoring and other monitoring aspects of managing those patients? So I think that that's the biggest thing is you want to be logical right, you want to be logical, you want to be smart, and you want to do the right testing. And of course, part of this is also shared decision making, making sure that the patients that you put on these medicines are appropriate.

What additional tips and insights would you like to share with your colleagues regarding your session for Fall Clinical on boxed warnings?

Dr Christopher Bunick: Yeah, I think there's a couple points I would make, and one sort of harking back to that long-term safety data that we've seen emerge for JAK inhibitors for atopic dermatitis, is that the population that was used to obtain this long-term data really captured or represented your average day American in terms of health. There were certain patients that had cardiovascular risk factors, or were a certain body size, or had smoking habits, or had women that were on oral contraceptives, and so we're going to dive into how the long-term safety data is not cherry-pick patients, but are actually real representative of the real world American today in 2023.

But what I hope to convey through my talk at Fall Clinical is kind of a shift in the thinking over the past two years. We've seen over the last couple of years a lot of highlights about JAK in the Box. This plays off this theme of JAK in the Box, and I really want to put that to rest. We're not really talking... We don't want to be stuck talking about JAK in a Box. What we want to be talking about is what I call JAK Frost right, the cooling down of inflammation and itch in our atopic dermatitis patients and our other inflammatory dermatologic diseases. So I'm going to emphasize this paradigm shift. Let's move away from getting stuck in JAK in the Box, and let's move towards thinking about JAK Frost. Cooling down this inflammation and itch in our inflammatory skin disease patients. And I think this is a winning narrative that's going to help dermatologists connect with their patients going forward.