Upadacitinib Safety for Treating Moderate to Severe Atopic Dermatitis

A recent study published in the Journal of Allergy and Clinical Immunology revealed that upadacitinib was well tolerated and did not pose any new significant safety risks when used to treat atopic dermatitis (AD).

The researchers aimed to evaluate the safety profile of upadacitinib, a selective reversible Janus kinase inhibitor, in patients with moderate to severe AD. The study analyzed safety data from the 16-week placebo-controlled periods of one phase 2b study and three ongoing phase 3 studies. Furthermore, they also examined the longer-term safety data from patients who received upadacitinib during the blinded extension periods of the phase 3 studies. The safety results were found to be consistent between the 16-week and all upadacitinib exposure groups.

A total of 2485 patients, including 333 adolescents, were included in the analysis. These patients received either upadacitinib 15 mg (n = 1239) or 30 mg (n = 1246) for an average duration of approximately 1 year. Both adults and adolescents showed good tolerability to upadacitinib, with no new important safety risks identified compared to the known safety profile of the drug.

The study reported treatment-emergent adverse events (TEAEs) as exposure-adjusted rates per 100 patient-years (PY). The incidence of TEAEs and discontinuation due to adverse events was slightly higher in patients receiving 30 mg of upadacitinib compared with those receiving 15 mg. However, the serious adverse event rates were similar in both groups. The most frequently reported adverse event was acne, with slightly higher rates observed in the 30-mg group compared with the 15-mg group. Rates of serious infections were comparable across both treatment groups.

The study also evaluated other safety parameters, including major adverse cardiovascular events, venous thromboembolic events, and malignant neoplasms. The rates of these events were low and within expected ranges for the general population, with adjudicated major adverse cardiovascular event and venous thromboembolic event rates being less than 0.1 events per 100 PY.

“Upadacitinib was well tolerated, and no new important safety risks were observed among adults and adolescents with moderate to severe AD treated for approximately 1 year compared to the known safety profile of upadacitinib,” concluded the study authors.

Reference
Guttman-Yassky E, Thyssen JP, Silverberg JI, et al. Safety of upadacitinib in moderate-to-severe atopic dermatitis: an integrated analysis of phase 3 studies. J Allergy Clin Immunol. 2023;151(1):172-181. doi:10.1016/j.jaci.2022.09.023