WEDNESDAY, Nov. 29, 2023 -- For patients with moderate-to-severe atopic dermatitis who did not achieve the Investigator's Global Assessment of clear/almost clear skin (IGA 0/1) at week 16 and/or used rescue medication in the ECZTRA 1 and 2 trials, tralokinumab provides clinically meaningful responses, according to a study published online Oct. 7 in the American Journal of Clinical Dermatology.

Eric L. Simpson, M.D., from Oregon Health and Science University in Portland, and colleagues conducted a post-hoc analysis involving 1,328 patients from ECZTRA 1 and 2 who did not achieve the coprimary end point of IGA 0/1 at week 16 without rescue medication. The authors sought to examine the impact of tralokinumab versus placebo on other clinically meaningful parameters.

The researchers found that at week 16, a significantly greater proportion of patients receiving tralokinumab versus placebo achieved a 50 percent improvement in the Eczema Area and Severity Index, a ≥3-point improvement in the itch Numerical Rating Scale (22.6 versus 9.4 percent), or a ≥4-point improvement in the Dermatology Life Quality Index (41.2 versus 24.5 percent). Furthermore, a numerically greater proportion of tralokinumab- versus placebo-treated patients achieved all three measures of clinically meaningful response (30 versus 18 percent) or a clinically meaningful change in at least one outcome (48.8 versus 28.5 percent). Additional clinician-reported and patient-reported outcomes were achieved by significantly greater proportions of patients receiving tralokinumab versus placebo.

"Using multiple validated outcome measures of both efficacy and quality of life, including patient-reported outcomes, alongside IGA scores, can better characterize treatment responses in patients with moderate-to-severe atopic dermatitis," the authors write.

Several authors disclosed ties to biopharmaceutical companies, including Leo Pharma A/S, which manufactures tralokinumab and funded the ECZTRA 1 and 2 clinical trials.