Upadacitinib increases risk of herpes zoster, serious infections and skin cancer in RA patients: BMJ

In a recent study examining the safety of upadacitinib in rheumatoid arthritis (RA) patients, researchers have reported an increased risk of serious adverse events (AEs) in individuals aged 50 years and above, with cardiovascular (CV) risk factors. The findings were published in the Annals of the Rheumatic Diseases.

The research analyzed data from six phase III clinical trials involving a total of 3209 patients receiving upadacitinib 15 mg once daily, 579 patients receiving adalimumab (a tumor necrosis factor inhibitor) with concomitant methotrexate (MTX), and 314 patients on MTX monotherapy. Approximately 54% of the patients were included in the higher-risk population, as they were aged 50 years and above and had at least one CV risk factor.

The findings showed that major adverse cardiovascular events (MACE), malignancies (excluding non-melanoma skin cancer), and venous thromboembolism (VTE) were more frequent in the higher-risk groups compared to the overall population. However, the incidence rates of these adverse events were similar between patients treated with upadacitinib and those treated with adalimumab.

Moreover, the study identified higher rates of serious infections in upadacitinib-treated patients within the higher-risk population. Additionally, upadacitinib showed increased rates of non-melanoma skin cancer (NMSC) and herpes zoster (HZ) across all populations compared to the comparators.