Christopher Bunick, MD, PhD, Discusses Late-Breaking Long-Term 4-Year Safety Data of Upadacitinib for AD

"I think it is very encouraging for the dermatology field that JAK inhibitors, as more and more long-term safety data comes out, starting with this one on upadacitinib at 4 years, they're proving safer and safer than we could have imagined. And it's exactly what we hoped for," said Christopher Bunick, MD, PhD, at RAD 2023. Bunick, associate professor of dermatology at the Yale School of Medicine, presented late-breaking research on long-term data of upadacitinib for atopic dermatitis treatment.

Transcript

Christopher Bunick, MD, PhD: I'm Christopher Bunick, associate professor of dermatology at Yale University, and it's been my pleasure to be here at the Revolutionizing Atopic Dermatitis Conference in Washington, DC, where I just did a late-breaker presentation on the long-term, 4-year safety data of upadacitinib in the treatment of atopic dermatitis patients. Upadacitinib is a JAK inhibitor, and everyone in dermatology is very interested about the safety of JAK inhibitors. And in this particular talk, I focused on the fact that this is the longest safety data analysis for any JAK inhibitor approved for atopic dermatitis that's currently been published. What was learned? Well, there's a couple key things that dermatologists should know. What was first presented was patient background characteristics, showing that patients were not cherry picked. These were real world patients that have real world comorbidities. And what I mean by that is around 60% of the patients that were in this combined analysis of 3 phase 3 trials. 60% had a cardiovascular risk factor. We had patients, 20% of them, that were on oral contraceptives. None developed venous thromboembolism. We had many patients with diabetes, with hypertension, other cardiovascular risk factors, yet, the rates of adverse cardiovascular events, embolic phenomenon, as well as malignancy, were incredibly low. And so that leads to another take home point is that after 4 years of pooled safety analysis of upadacitinib, and this includes both 15 milligram and 30 milligram doses, there were no new safety signals -- very important, no new safety signals. And in fact, the rates of some of the serious adverse events that dermatologists have been concerned about, like the effect on the heart and heart attack or other cardiovascular events, and clotting, actually were lower than some of the background rates published for patients with atopic dermatitis, or the US population in general, that are not on treatment for their atopic dermatitis. And this is really important because it puts these findings into context, that actually patients on upadacitinib may fare better in terms of some of the adverse outcomes that are seen in untreated disease. And in fact, the last thing that I pointed out in this talk was the fact that the safety data overall couples with high efficacy, so we have a very efficacious and very safe product that we are giving to our atopic dermatitis patients. And this is very important for educating our patients to be able to tell them that at 4 years of using this medicine that represents over 3000 patient years of data, the safety signals remain constant, there is no increase in events, and that everything that patients and providers tend to be worried about remain at incredibly low levels. So I think it is very encouraging for the dermatology field that JAK inhibitors, as more and more long term safety data comes out, starting with this one on upadacitinib at 4 years, they're proving safer and safer than we could have imagined. And it's exactly what we hoped for.

Dermatology Times®: What are the benefits to a more focused conference like RAD?

Bunick: I think it's really exciting to be here at Revolutionizing Atopic Dermatitis or the RAD conference. It's a smaller conference, and I think there's several benefits to having the smaller conference. And that is number 1. There's a more intimate feel, right? Everyone's in the same room. You have close contact with speakers, faculty, industry representatives. So I think that it's a more intimate atmosphere, and it's one that I think allows for more direct exchange with people. Maybe at a larger meeting, you have difficulty speaking with some of the people doing the research or the faculty presenting the research. And I think here at RAD, what's really unique is there's a lot of face-to-face interaction with the people that are really driving forward the transformative care of our atopic dermatitis patients, and I think that's a real value of being here at RAD.

[Transcript edited for clarity]