An integrated long-term analysis showed no new safety signals.

Upadacitinib for the treatment of moderate-to-severe atopic dermatitis (AD) was shown to have an acceptable safety profile at 5 years, according to a new integrated analysis.

Upadacitinib, a selective, reversible oral JAK1 inhibitor, was approved for the treatment of moderate-to-severe AD in adults and adolescents. In a new analysis presented at Maui Derm 2024, researchers looking at the long-term safety of the 15 mg and 30 mg doses integrated data from the ongoing global pivotal phase 3 Measure Up 1, Measure Up 2, and AD Up trials. They randomized patients 1:1:1: to oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily alone (Measure Up 1 and Measure Up 2) or with concomitant topical corticosteroids (AD Up). Those receiving upadacitinib 15 mg or 30 mg at week 16 continued their assigned treatment in a blinded extension period, and patients receiving placebo were randomly assigned (1:1) to receive the study drug at 15 mg or 30 mg in a blinded extension period.

The final integrated analysis included 2,683 patients (2,154 adults and 529 adolescents) who had received at least one dose of upadacitinib. The study researchers looked specifically at emergent adverse events of special interest (AESI), which they set as exposure-adjusted rates per 100 patient-years (PY) for the duration of the entire treatment period. According to the analysis results, the rates of AESI were similar to the results of the 1-year safety analysis for the following: serious infections, opportunistic infections, active tuberculosis, herpes zoster, non-melanoma skin cancer, malignancy excluding non-melanoma skin cancer, gastrointestinal perforations, adjudicated major adverse cardiovascular events, and adjudicated venous thromboembolic events. Rates of adverse events leading to death were also low, and rates of serious infection remained low for the 1-year and 5-year time points. The researchers reported that the upadacitinib was well-tolerated by adults and adolescents alike.

“Current safety analysis continues to support a favorable benefit-risk profile of upadacitinib in the treatment of patients with moderate-to-severe AD for up to 5 years of treatment, including over 7,000 years of patient exposure,” the authors concluded.

Source: Bunick C, Chovatiya R, Guttman E, et al. Long-term 5-year safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis including over 7000 patient-years of exposure. Abstract 12632. Presented at: Maui Derm, January 22-26, 2024.