What Is the Safety Profile of Upadacitinib Across Indications?

Join Jessica Farrell, PharmD, a clinical pharmacist at Albany Med's Division of Rheumatology and professor at Albany College of Pharmacy and Health Sciences, as she reviews a critical study on the safety of upadacitinib across multiple indications.

Patient concerns about medication safety remain a major barrier to initiating biologics and targeted synthetic therapies. This study, published in RMD Open in February 2023, evaluates over 15,000 patient-years of upadacitinib exposure in rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis, providing crucial real-world safety insights.

Findings revealed consistent rates of treatment-emergent adverse events across all disease populations, with slightly higher incidences in rheumatoid and psoriatic arthritis patients. Notably, herpes zoster occurred at a rate of 1.6 to 3.6 per 100 patient-years, reinforcing the importance of vaccination before treatment initiation. Other key safety concerns, including major adverse cardiovascular events (MACE), venous thromboembolism (VTE), and malignancies, were found to be rare and comparable to active comparators such as methotrexate and adalimumab.

The study provides critical data to help clinicians guide informed discussions with patients regarding JAK inhibitor safety. While class-wide black box warnings remain, ongoing research is essential to determine whether risks are drug-specific or apply universally to all JAK inhibitors.

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