6-Year Data Support Long-Term Safety of Upadacitinib

At the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France, Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine and Editor-in-Chief of Dermatology Times, presented new long-term data on the safety profile of upadacitinib in dermatologic use.

The analysis focused on 6-year safety outcomes, making it one of the longest data sets currently available for a Janus kinase (JAK) inhibitor in dermatology. “I had the privilege of presenting a late breaking presentation on the safety of upadacitinib. Now, this was a particularly unique study because it involved a couple different things. First, it was looking at 6-year safety data,” Bunick explained.

The data demonstrated a consistent and stable safety profile over time, with no new signals emerging compared with earlier reports. This is of clinical relevance given the concerns surrounding JAK inhibitors and their long-term tolerability, especially regarding malignancy, cardiovascular risk, and serious infections. As Bunick highlighted, the findings “really provided reassurance to dermatologists that long-term use of upadacitinib continues to be safe and manageable.”

Importantly, the study encompassed a large, multinational cohort, reflecting real-world clinical diversity. This allows clinicians to better understand the applicability of upadacitinib across different patient populations. While adverse events such as acne, upper respiratory infections, and laboratory abnormalities were observed, these remained consistent with prior data and were not progressive with extended treatment duration.

For clinicians managing atopic dermatitis and other inflammatory skin diseases, these findings contribute to the ongoing evaluation of benefit-risk balance. Upadacitinib remains an effective option for patients with moderate to severe disease who may have limited alternatives. As Bunick emphasized, “One of the most important things about the EADV conference is it truly represents global dermatology. We are bringing together providers to really understand how to care for patients of all types of skin.”

In conclusion, the 6-year safety update on upadacitinib provides further evidence supporting its long-term use in dermatology. Clinicians should continue to individualize therapy, monitor for known adverse effects, and consider these findings when making treatment decisions for chronic inflammatory skin conditions.