Clinically Meaningful Improvements in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab who did not Achieve Clear or Almost Clear Skin at Week 16

Investigator’s Global Assessment (IGA) of clear/almost clear (0/1) skin is a high standard to achieve after 16 weeks of treatment for patients with moderate-to-severe atopic dermatitis (AD) and does not capture clinically meaningful responses in other patient domains, such as improvement in itch and/or quality of life. To better evaluate the effect of tralokinumab in adolescents, we assessed the clinically meaningful impact of tralokinumab versus placebo in patients who did not meet IGA 0/1 at week 16 without rescue medication in ECZTRA 6. These post hoc analyses included adolescents from the ECZTRA 6 (NCT03526861) phase 3 trial who did not achieve IGA 0/1 at week 16 without rescue medication (referred to as IGA >1). Clinically meaningful responses were defined as either ≥50% improvement from baseline in Eczema Area and Severity Index (EASI-50), ≥3-point improvement in Adolescent Worst Pruritus Numeric Rating Scale (itch NRS), or ≥6-point improvement in Children’s Dermatology Life Quality Index (CDLQI) at week 16. Among IGA >1 patients (n = 247), significantly greater percentages receiving tralokinumab (150 mg or 300 mg) versus placebo achieved EASI-50 (31.2% or 41.3% versus 10.0%), ≥3-point improvement in itch NRS (21.6% or 22.8% versus 8.0%), or ≥1 clinically meaningful measure (36.4% or 52.5% versus 21.1%) at week 16. The majority of IGA >1 patients who continued with open-label tralokinumab beyond week 16 achieved EASI-50 and ≥3-point improvement in itch NRS and about 40% met EASI-90 at week 52. Clinically meaningful responses in both clinician-measured and patient-reported outcomes were observed in tralokinumab-treated (150 mg or 300 mg) adolescents who did not achieve IGA 0/1 at week 16 without rescue medication. Utilizing validated outcome measures of both efficacy and patient quality of life, alongside IGA scores, can enhance clinical decision-making regarding tralokinumab treatment responses in adolescents with moderate-to-severe AD. ClinicalTrials.gov identifier, NCT03526861 (ECZTRA 6); study start date: 19 June 2018; primary completion date: 15 April 2020; study completion date: 16 March 2021. A Graphical Abstract is available for this article. Atopic dermatitis is a common and chronic skin disease where patients experience severe itch and skin lesions. Atopic dermatitis can negatively affect patient quality of life, especially for adolescents, whose self-esteem and body image can greatly influence their perception of social interactions. Tralokinumab is a medication that is approved for treating moderate-to-severe atopic dermatitis in patients aged 12 years and up. Clinical trials for atopic dermatitis therapies often define treatment success using a single clinician-measured metric of clear or almost clear skin at week 16. Patients who do not achieve this are considered a treatment failure. However, this limited definition of treatment success does not reflect the complete patient experience, especially for those with lesions across much of their skin. Here, we used data from the ECZTRA 6 phase 3 clinical trial, funded by LEO Pharma A/S, to analyze if adolescent patients treated with tralokinumab, who did not meet the trial definition for treatment success, still showed meaningful improvement in atopic dermatitis symptoms. Overall, in this group, a larger percentage of patients treated with tralokinumab, compared with those who did not receive active drug (i.e., placebo), showed improvements in the severity of skin lesions, itch, and patient quality of life at week 16. Additionally, patients continued to improve with ongoing tralokinumab treatment beyond week 16. Our results suggest using several outcomes directly reported by patients, in addition to clinician-measured metrics, can better inform tralokinumab treatment management in adolescents with moderate-to-severe atopic dermatitis

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