The following is a summary of “Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies,” published in the January 2023 issue of Allergy & Clinical Immunology by Yassky, et al.
A selective reversible Janus kinase (JAK) inhibitor with proven effectiveness in treating moderate-to-severe atopic dermatitis is upadacitinib (AD). In individuals with moderate-to-severe AD, upadacitinib’s safety was examined by researchers for a study.
Integrated safety data from 1 phase 2b and 3 current phase 3 trials (16 weeks of placebo-controlled periods), as well as longer-term safety data from patients who received upadacitinib during the 3 phase 3 studies’ 3 blinded extension periods, were reviewed (all upadacitinib exposure). Exposure-adjusted rates per 100 patient-years (PY) for treatment-emergent adverse events (TEAEs).
The 16-week exposure group and all other upadacitinib exposure groups had comparable safety outcomes. About 2,485 patients (333 teenagers) in the latter group received upadacitinib at doses of 15 mg (n = 1,239) or 30 mg (n = 1,246) for a median time of almost one year. Both adults and teenagers tolerated upadacitinib well. Patients receiving 30 mg of upadacitinib (respectively, 311.9 and 5.7 events per 100 PY) had more TEAEs and discontinuation owing to AEs than those receiving 15 mg (respectively, 274.6 and 4.4 events per 100 PY). In both groups, the rates of serious adverse events (15/30 mg, 7.1/7.7 occurrences per 100 PY) were comparable. The most common adverse event (15/30 mg, 13.3/20.2 occurrences per 100 PY) was acne. Rates of serious infections were comparable between treatment groups. Venous thromboembolic event rates and serious adverse cardiovascular event rates were both ≤ 0.1 per 100 PY. Malignant neoplasm incidence rates were within the normal range for the general population.
When compared to the upadacitinib’s existing safety profile, it was well tolerated, and no additional significant safety hazards were seen in adults and adolescents with moderate-to-severe AD treated for around a year.