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Conclusions of Study on Long-Term Safety Study of Upadacitinib for AD


Christopher Bunick, MD, PhD, discusses the major study conclusions about the safety of upadacitinib as a treatment for atopic dermatitis.

Christopher Bunick, MD, PhD: If we compare these rates to the background population, what does it mean? How can you properly understand the event rates per 100 patient-years for these serious adverse events and special interests if you don’t understand the background rates in atopic dermatitis [AD] or general population? From the 4-year safety data of upadacitinib, we’re showing the malignancy rates, excluding nonmelanoma skin cancer for UK patients with AD that’s mild to severe. The incidence rate per 100 patient-years is around 0.33. For the general US population, it’s around 0.45. So the upadacitinib malignancy rates are right there, equivalent to the background rates in the general US population or the AD population, showing that there’s a coherence between the rates being seen. Upadacitinib isn’t shooting up malignancy rates much beyond what we’re seeing in the background [for patients with] AD or the general population.

The same thing holds for MACEs [major adverse cardiovascular events] and VTE [venous thromboembolism], where MACE and VTE rates were less than 0.1 for event per 100 patient-years. In a Danish population with moderate to severe AD, the incidence rate was 0.63. VTE in US patients with moderate to severe AD was 0.31. I’m hoping that these data are convincing you that upadacitinib has consistently low rates of adverse events in 2 to 4 years, supporting its safety for long-term use in patients with AD.

The analyzed population was a good representation of your average 21st-century human, for whom the most common adverse event was herpes zoster. But we talked about the vaccine and how less than 5% of these patients were vaccinated and the need for the vaccine could help reduce this adverse event. We talked about MACE and VTE incidence rates being markedly below those of the background AD populations from Denmark or the US. Malignancy rates were at or below the malignancy rates in background populations. Of the 2700 patients analyzed over 4 years, there have been only 3 deaths related to COVID-19 infection with patients who have cardiovascular risk factors.


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