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Visualizing Safety Rates: Drug Events, Disease Baseline, and General Population Baseline


Christopher Bunick, MD, PhD, discusses a novel tool to visualize key safety results of Janus kinase inhibitors in treating patients with atopic dermatitis.

Christopher Bunick, MD, PhD: In the paper, looking at the JAK [Janus kinase] inhibitor safety compared to traditional systemic immunosuppressive, we came up with a really, what I think is an innovative way to think about adverse event rates. In this kind of bull’s-eye diagram here, what we’ve done is in the middle we’ve put the reference data, so the background population. These are the event rates in the background population. So you have the nonmelanoma skin cancer in the upper left, malignancy excluding nonmelanoma skin cancer in the upper right, VTE [venous thromboembolism] in the lower right, and then MACE [major adverse cardiovascular events] in the lower left. What I like about this diagram is it quickly gives a provider what the event rate is with a specific medicine. What’s the event rate specifically the AD [atopic dermatitis] baseline, which is the middle shell, and then what is it in the background population? For example, if we look at VTE in the lower right, the background, the event rate is around 0.25 events per 100 patient- years, and moderate-to-severe AD, it’s 0.31. But if you look at abrocitinib [Cibinqo] and upadacitinib [Rinvoq], the event rates are much lower except for the 1200 mg dose of upadacitinib, but the event rates are much lower than both the AD population and the background population, suggesting that the JAK inhibitors may have anti-inflammatory properties in preventing or reducing VTE. So what I hope for the future is that this particular diagram can be updated, where we update the background and reference, update the AD baseline, and update based on the different therapies, and that this same type of diagram can be used for other medications to help a provider understand [the] 3 levels of safety, the drug’s event rate, the disease’s baseline, and the general populations’ baseline. I think that gives a more holistic understanding of safety when we think about it that way.


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