Upadacitinib Well Tolerated Across Multiple Inflammatory Conditions

In a recent study published in RMD Open, the long-term safety profile of upadacitinib, a medication utilized in the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and atopic dermatitis (AD), was evaluated.

Research aimed to provide a comprehensive understanding of the incidence and nature of adverse events associated with upadacitinib across these diverse disease populations. The analysis included safety data from clinical trials of upadacitinib, specifically focusing on the 15-mg dose for RA, PsA, and AS and the 30-mg dose for AD. In total, 6991 patients who received at least one dose of upadacitinib were included in the analysis, representing a cumulative exposure of 15 425 patient-years across the different diseases. The maximum duration of treatment ranged from 2.75 to 5.45 years, depending on the disease.

The results indicated that the rates of treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation were similar across the diseases. However, the incidence of serious TEAEs was numerically higher in patients with RA and PsA compared with those with AS and AD.

Certain adverse events were observed at higher rates with upadacitinib compared with active comparators in the RA and PsA populations. These included herpes zoster (shingles), nonmelanoma skin cancer, and elevations in creatine phosphokinase levels, which are indicators of muscle damage. However, the rates of serious infections, major adverse cardiovascular events, venous thromboembolism, and malignancies were generally lowest in the AS and AD populations.

Notably, rates of acne were increased only in patients with AD, which may be specific to the underlying condition.

“Findings from this analysis demonstrate that upadacitinib is generally well tolerated with observed differences in safety profiles likely reflective of varying patient characteristics across RA, PsA, AS and AD populations,” concluded the study authors.

Reference
Burmester GR, Cohen SB, Winthrop KL, et al. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023;9(1):e002735. doi:10.1136/rmdopen-2022-002735