The post hoc analysis published in JAMA Dermatology studied the safety and efficacy of tralokinumab in adults aged 65 and older.
Tralokinumab was found to be safe, well-tolerated, and effective in older adult patients with moderate-to-severe atopic dermatitis, according to a study published by Merola et al in JAMA Dermatology.1 The study authors completed a secondary analysis of the 3 phase 3 clinical trials, ECZTRA 1, 2, and 3 to better understand whether tralokinumab was tolerated among patients aged 65 and older who face unique challenges, including comorbidities, polypharmacy, and higher risk of infections.
According to the authors, older adult patients with atopic dermatitis experience a greater disease burden but are underrepresented in clinical trials. Treatment challenges can also include potential safety risks and low adherence to conventional therapies such as corticosteroids, phototherapy, and immunosuppressants.
Tralokinumab specifically targets IL-13 and showed significant improvements in Investigator’s Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores in the ECZTRA trials.
In Merola et al’s post hoc analysis, patients were separated into 3 age groups, 18 to 49 years, 50 to 64 years, and 65 years and older. Randomization was not stratified by age cutoffs. The primary efficacy end points were the proportion of patients achieving IGA 0 or 1 and the proportion of patients achieving at least 75% EASI improvement (EASI –75) at week 16. One of the key secondary efficacy end points included an itch Numeric Rating Scale (NRS) score of 4 or more points at week 16.
Safety outcomes included treatment discontinuations and the number and percentage of patients with 1 or more adverse events (AEs) at 16 weeks. Categories of AEs included any treatment-emergent AE (specifically cardiovascular outcomes), AEs of special interest, and serious AEs (SAEs).
Of the 104 older adult patients included in the post hoc analysis, 75 were treated with tralokinumab and 29 were treated with placebo. The mean age of the 65 years or older group in the ECZTRA trials ranged from 70 to 73 years, the mean body surface area was 38.8% to 50.2%, and the weekly average worst daily pruritus NRS was 7 to 8. More than 56% of older patients receiving tralokinumab from the ECZTRA trials lived with polypharmacy.
Patients who received tralokinumab had numerically fewer AEs that led to discontinuation than patients given placebo. “Three patients (4%) receiving tralokinumab and 3 (10.3%) receiving placebo experienced SAEs, with no reports of neoplasms in the placebo group and 1 in the tralokinumab group. No patients in the tralokinumab arm experienced vascular disorders; 1 patient experienced accelerated hypertension and deep vein thrombosis in the placebo group. There were no reports of herpes zoster. Additionally, no deaths were reported.”
The proportions of older adult patients who achieved EASI-75 and IGA 0/1 in ECZTRA 1, 2, and 3 at week 16 were greater in the tralokinumab group than in the placebo group. The proportion of patients who achieved a worst pruritus NRS reduction of 4 or greater in ECZTRA 1 and 2 was greater in the tralokinumab group, and in ECZTRA 3, the proportion of patients who met a worst pruritus NRS reduction of 4 or greater was similar between both arms.
According to Merola et al, their post hoc analysis results suggest that tralokinumab is safe, effective, and well-tolerated among older adult patients with moderate-to-severe atopic dermatitis. “The trends observed and interaction P values in this descriptive analysis suggest that there was similar efficacy among all age cohorts. Although more than half of older adults in the tralokinumab and placebo groups experienced AEs, only 5.3% and 6.9% of patients in the tralokinumab and placebo groups, respectively, had events that led to treatment discontinuation. These discontinuation rates were higher than those from the 2-year interim analysis of the long-term extension trial in the full population, in which only 1.6% discontinued due to an AE.”
The authors noted that limitations of the study include that the analysis was not statistically powered to examine the efficacy and safety of tralokinumab in older adults and that it only considered the 16-week end point.
“In this secondary analysis of 3 randomized clinical trials, the proportion of patients 65 years or older treated with tralokinumab who experienced SAEs or any AE that led to permanent treatment discontinuation was low compared with placebo at 16 weeks. More older adults achieved EASI-75 and IGA 0/1 with tralokinumab than with placebo. These findings suggest that tralokinumab is safe and effective in those 65 years or older with moderate-to-severe AD,” Merola et al concluded.