The following is a summary of “Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial,” published in the October, 2022 issue of Dermatology by Blauvelt, et al.
For moderate-to-severe atopic dermatitis (AD), further long-term therapies are required. Tralokinumab with optional topical corticosteroids was evaluated in participants from earlier tralokinumab parent trials (PTs) who have moderate-to-severe AD as part of the open-label, ongoing 5-year extension of ECZTEND. For a study, researchers sought to assess the safety and effectiveness of tralokinumab therapy lasting up to 2 years.
Regardless of the amount of tralokinumab exposure time, safety assessments included people from PTs that were completed and enrolled in ECZTEND. Adult patients receiving tralokinumab in ECZTEND for ≥1 year were included in the efficacy studies, and subgroup analyses of patients who had been receiving the medication for more than 2 years were also conducted (1 year from PT, 1 year in ECZTEND). With additional effectiveness endpoints, the number of adverse events served as the primary end goal.
In the safety analysis set, participants receiving tralokinumab had an exposure-adjusted incidence of 237.8 adverse events/100 patient-years of exposure (N = 1,174). Even though they occurred at lower rates, exposure-adjusted incidence rates of frequent adverse events were comparable to PTs. Improvements in the extent and severity of AD were maintained after 2 years of tralokinumab treatment, with the Eczema Area and Severity Index (EASI-75) being present in 82.5% of patients (N = 345).
Tralokinumab was well tolerated over the course of two years and sustained long-term management of AD signs and symptoms.