Tralokinumab Promising for Long-Term Treatment of Atopic Dermatitis

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The safety and efficacy of up to 2 years tralokinumab treatment in a post hoc interim analysis is reported.

Tralokinumab, a monoclonal antibody which inhibits interleukin (IL)-13, was well-tolerated and effective for atopic dermatitis (AD), controlling signs and symptoms during 2 years in adults with moderate to severe AD, according to data from a post hoc interim analysis from the ongoing, open-label, 5-year extension trial ECZTEND published in the Journal of the American Academy of Dermatology.

Patients who completed tralokinumab “parent” trials (PTs) were invited to enroll in the ECZTEND extension trial, which has a single-arm, multicenter design. Patients were eligible to enroll regardless of previous PT treatment (tralokinumab or placebo) or treatment response. ECZTEND patients received tralokinumab 300 mg subcutaneously every 2 weeks after a 600 mg loading dose. The primary endpoint is the number of adverse events (AEs) during the treatment period from baseline to week 268 (5 years). Secondary endpoints include the percentage of patients who achieved Investigator’s Global Assessment (IGA) scores of 0/1 (clear/almost clear) and at least 75% improvement in Eczema Area and Severity Index (EASI) relative to PT baseline (EASI-75). Optional topical corticosteroids (TCS) were allowed at the investigator’s discretion.

The interim efficacy analysis included adults treated with tralokinumab in ECZTEND for at least 1 year regardless of PT treatment or response. For a more homogenous patient group, a 2-year subgroup of patients on tralokinumab for 52 weeks in PTs and 56 weeks in ECZTEND was also analyzed. Event rates are presented as the number of events per 100 patient-years of exposure (PYE).

Of 345 patients in the 2-year efficacy analysis, 58.8% were male and the median age was 42 (IQR, 30-52) years. Of 1174 patients in the safety analysis, 57.5% were male and the median age was 38 (IQR, 27-50) years. The majority (>70%) of patients in both groups were White, and the median age of AD onset in both groups was 3 (IQR, 1-15) years of age.

The safety analysis showed an exposure-adjusted incidence rate of 237.8 adverse events/100 PYE, and 4.8 serious adverse events/100 PYE. There were no deaths. Most AEs were mild or moderate and resolved, and 24.2% of patients experienced 1 or more treatment-related AEs. The most commonly reported AEs (>2%) were viral upper respiratory tract infection, AD, and upper respiratory tract infection. There were 2 patients reporting severe conjunctivitis and 1 patient discontinued treatment because of conjunctivitis.

EASI-75 and EASI-90 were achieved by 82.8% and 61.0%, respectively, of patients in the 1-year efficacy analysis set, and IGA scores of 0/1 were achieved by 49.7% of patients. Patients in the 2-year efficacy analysis set maintained high EASI-75, EASI-90, and IGA 0/1 response rates. About one third of patients reported mild or moderate topical corticosteroid use within the previous week or any point of follow-up. In the 2-year subgroup, median percentage improvement in EASI after 1 year of tralokinumab in PTs was 88.0%. Itch improved from severe to mild, and sleep improved from severe to mild interference at 2 years of tralokinumab treatment.

The study was limited by possible selection bias and its open-label, single-arm design.

“These data support specific inhibition of IL-13 with tralokinumab as a safe and efficacious option for the long-term treatment of moderate-to-severe AD,” the study authors wrote.

Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. This research was supported by LEO Pharma A/S. Please see the original reference for a full list of disclosures.

Reference

Blauvelt A, Langley RG, Lacour JP, et al. 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. J Am Acad Dermatol. 2022;87(4):815-824. doi:10.1016/j.jaad.2022.07.019