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Tralokinumab (Adbry) achieved meaningful responses in people with moderate-to-severe atopic dermatitis (AD) who had not previously reached the study's clinical goals.

The post-hoc analysis included 1,328 patients from ECZTRA 1 and 2 -- two monotherapy phase III trials. Patients were selected for the current study by not achieving the trial's co-primary endpoints: Investigator's Global Assessment of clear/almost clear skin (IGA 0/1) at week 16 without rescue medication.

Among ECZTRA 1 and 2 patients who did not achieve IGA 0/1 at week 16 without rescue medication, a significantly greater proportion of patients receiving tralokinumab versus placebo achieved an EASI-50 (Eczema Area and Severity Index) (33.0% vs 13.0%), a ≥ 3-point improvement in the Numerical Rating Scale (NRS) for itch (22.6% vs 9.4%), or a ≥ 4-point improvement in disease-related quality of life (DLQI) (41.2% vs 24.5%) at week 16.

The analysis appears in the . The following report excerpts have been edited for length and clarity.

What prompted this analysis?

Tralokinumab, currently approved in multiple countries including in Europe, Canada, and the U.S. for the treatment of moderate-to-severe AD in adults, is a fully human, IgG4 high-affinity monoclonal antibody that specifically binds to and neutralizes interleukin-13. In the ECZTRA trials with tralokinumab monotherapy in patients with moderate-to-severe AD, one of the co-primary endpoints was IGA 0/1 at week 16 without the use of rescue medication. Significantly more patients met the IGA 0/1 endpoint at week 16 with tralokinumab as compared with placebo.

Here, utilizing data from two pivotal phase III studies (ECZTRA 1 and 2), researchers assessed the impact of tralokinumab versus placebo on other clinically meaningful parameters in patients not achieving IGA 0/1 at week 16.

What were the key results?

Despite not meeting the study's endpoints, a significantly greater proportion of adult patients with moderate-to-severe AD receiving tralokinumab versus placebo exhibited clinically meaningful improvements in AD signs, symptoms, or quality of life (as measured by EASI-50, a ≥3-point improvement in itch NRS, and a ≥4-point improvement in DLQI). In addition, significantly greater proportions of IGA >1 patients receiving tralokinumab versus placebo achieved other commonly used endpoints, such as EASI-75, EASI-90, DLQI ≤5, and a ≥3-point improvement in sleep NRS.

Were there any findings regarding safety?

Tralokinumab was shown to be well tolerated and maintained long-term control of AD signs and symptoms.

What are the key take-home messages for clinicians?

A significantly greater proportion of adults with moderate-to-severe AD receiving tralokinumab versus placebo exhibited clinically meaningful improvements in AD signs, symptoms, or quality of life.

Notably, the current study utilized patient-reported outcomes (e.g., DLQI, itch NRS) as a complement to clinician-evaluated outcomes (e.g., EASI). According to the research team, a clinician's visual assessment of AD extent or severity can underestimate both the disease burden and extent of treatment benefit in patients. In a heterogeneous and chronic disease like AD, use of clinically meaningful parameters reflecting an improvement in signs, symptoms, and/or quality of life, including patient-reported outcomes, can considerably support clinicians during the treatment decision-making process and may prevent unnecessary switching of treatments.

Key points

• Tralokinumab provided meaningful improvement for AD patients who had not yet achieved study endpoints.
• Patient-reported outcomes can help guide clinical decision-making.
• Tralokinumab reported safe and well-tolerated.