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New data from ECZTRA 1 and 2 show patients unable to achieve complete skin clearance nonetheless benefitted in at least 1 component of disease improvement.
Tralokinumab may help patients with atopic dermatitis previously unable to achieve skin clearance with therapy reach not only such outcomes—but those indicating symptom and quality-of-life improvement as well.
In new post hoc analysis data from the pivotal phase ECZTRA 1 and 2 trials, a team of investigators reported that a 300 mg dose of the interleukin 13 (IL-13) targeting biologic therapy every other week provided a significant rate of improvement in any of Eczema Area Severity Index 50% (EASI-50), worst daily pruritus (itch) Numeric Rating Scale (NRS) improvement of ≥3 or Dermatology Life Quality Index (DLQI) improvement of ≥4 after 16 weeks.
The new findings, presented at the Society of Dermatology Physician Assistants (SDPA) 2022 Annual Meeting in Miami, FL this week, highlight the diverse and patient-centric outcomes capable with a type 2 inflammation-targeting therapy such as tralokinumab for chronic, heterogenous diseases like atopic dermatitis.
Led by Eric Simpson, MD, MCR, professor of dermatology at the Oregon Health & Science University School of Medicine, investigators sought to interpret the impact of tralokinumab versus placebo on “other clinically meaningful parameters” in patients from ECZTRA 1 and 2 who did not achieve IGA 0 or 1 at week 16 or had used rescue therapy.
Among the primary endpoints of the initial ECZTRA 1 and 2 trials were skin clearance achievement per IGA 0 or 1; while significantly more patients receiving tralokinumab achieved this mark versus placebo, Simpson and colleagues challenged the benefit of such a lone outcome for patients with atopic dermatitis.
“In a heterogeneous disease like AD, clinical decision making is based on a more holistic assessment of the initial response beyond the regulatory endpoint IGA 0/1,” investigators wrote. “Here we evaluated other important and clinically meaningful parameters reflecting improvement in signs, symptoms, and/or quality of life in patients who did not achieve IGA 0/1 at Week 16 or used rescue medication.”
Their assessment included non-responder imputation (NRI) and as-observed (AO) treatment arms for both 300 mg tralokinumab or placebo, each every other week for 16 weeks, across the 2 trials. Approximate mean age across the arms was late-30s; 6 in every 10 patients were male and approximately two-thirds were White. Mean atopic dermatitis duration at baseline was approximately 29 years. Mean body surface area involvement across the arms was approximately 55%.
Among 960 patients with IGA >1 at week 16, investigators observed that significantly greater portions of patients tralokinumab achieved EASI 50, ≥3-point improvement in Itch NRS, and ≥4-point improvement in DLQI. Approximately 82% achieved 1 of outcomes for improved disease signs, symptoms or quality of life.
In consideration of the same 960 patients, significant overlap was observed across the other measures of clinically meaningful disease improvement among those receiving tralokinumab:
“In a heterogeneous and chronic disease like AD, additional to the IGA 0/1 assessment, other important and clinically meaningful parameters reflecting improvement in signs, symptoms, and/or quality of life can help in the treatment decision making process,” investigators wrote.
The study, “Clinically meaningful responses achieved with tralokinumab in adults with moderate-to-severe atopic dermatitis who did not meet IGA 0/1 at initial 16-week treatment,” was presented at SDPA 2022.