Significant Proportion of Patients With AD Maintain Stable EASI With Tralokinumab Treatment

Greater than 70% of patients with atopic dermatitis (AD) who continued treatment with tralokinumab (Adbry; LEO Pharma) maintained a stable Eczema Area and Severity Index (EASI) score ≤ 7 at equal to or greater than 80% of days, according to results from the ECZTEND trial.¹

The results were presented in a poster² at the 2024 European Academy of Dermatology and Venereology Congress in Amsterdam, Netherlands, September 25-28.

Image Credit: © ltyuan - stock.adobe.com

Background and Methods

The ongoing ECZTEND trial (NCT03587805) is an open-label, 5-year extension of the phase 3 ECZTRA 1 and ECZTRA 2 parent trials.³

In total, 347 patients were included in the trial extension. These patients had been treated with tralokinumab and an additional, optional topical corticosteroid for 52 weeks in ECZTRA 1 and 2. The data cutoff for the below data took place April 30, 2022.

Findings

At baseline, the median age of participants was 42 years of age. Significantly more males (59.1%) were involved in the study versus 40.9% of female participants. The majority of participants (74.6%) were White, with Black (5.8%) and Asian (16.1%) patients also represented.

At the baseline of the ECZTRA 1 and 2 trials, all participants had an Investigator Global Assessment (IGA) score of 3 (49.6%) or 4 (50.4%). By baseline of ECZTEND, these scores were more evenly distributed across the clear/almost clear (28.2%) and mild (35.4%) categories.

The median EASI score was 4.7% at the start of ECZTEND, while the median Scoring Atopic Dermatitis (SCORAD) was 32.8, and the median Dermatology Life Quality Index (DLQI) was 5.0. Similarly, the median worst weekly pruritus Numerical Rating Scale (NRS) began at 5.0.

Of 332 patients, approximately 32.2 individuals achieved EASI ≤ 2 for ≥80% of days. Likewise, 71.4 individuals achieved EASI ≤ 7 for the same number of days. DLQI ≤ 5 was achieved by 61.2 participants, while worst weekly pruritus NRS was achieved by 48.5 patients for ≥80% of days. In total, 53.9 patients achieved EASI ≤ 7 and DLQI ≤ 5 or pruritus NRS for equal to or greater than 80% of days.

Among all patients, 60.2% of patients achieved the target outcome of EASI ≤ 7 for 100% of days between weeks 16 and 56. In total, 66.7% achieved EASI ≤ 7 for 100% between weeks 56 and 112.

72.6% achieved EASI ≤ 7 between weeks 112 and 152, while 52.1% achieved the metric throughout the full study period.

Conclusions

Poster authors wrote that a "high proportion of patients maintained a stable response with minimal or no fluctuations" with respect to both patient-reported and physician-reported outcomes.

"These data show that it is possible to transition from flare-driven treatment with topical therapies to stable disease control with long-term tralokinumab treatment in adult patients with moderate-to-severe AD," according to Blauvelt et al.

References

1. Long-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials - ECZTEND. ClinicalTrials.gov. Updayed August 5, 2024. Accessed October 3, 2024. NCT03587805
2. Blauvelt A, Hong C, Peris K, et al. Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, Netherlands.
3. Simpson EL, Pink AE, Blauvelt A, et al. Tralokinumab efficacy over 1 year in adults with moderate-to-severe atopic dermatitis: pooled data from two phase III trials. Am J Clin Dermatol. 2023;24(6):939-952. doi:10.1007/s40257-023-00806-3