Tralokinumab Shows Long-Term Efficacy for AD in Sensitive Areas

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At the recent European Academy of Dermatology and Venereology Congress in Amsterdam, Netherlands, September 25 to 28, a poster was presented with data on the efficacy of long-term tralokinumab treatment in patients with atopic dermatitis (AD) on the head and neck regions. The data, collected through a post hoc analysis of 2 phase 3 clinical trials and an on-going ECZTEND open-label trial, found that 87.2% of patients treated with the drug for up to 4 years had a reduced eczema area and severity index (EASI) score from 3.0 at parent trial baseline to less than 1 at week 152.¹

“AD in the head and neck region can be particularly burdensome for patients, and it also presents a unique challenge for clinicians given the difficulty of high-level disease control in this area,” said Raj Chovatiya, MD, PhD, MSCI, an investigator behind the analysis. “These data showed that tralokinumab treatment resulted in sustained improvement of disease in the head and neck region for up to 4 years, showing that tralokinumab can be an effective first-line systemic therapy in patients with moderate to severe AD - especially those with substantial head and neck involvement at baseline and overall severe disease.”

Background

When treating a patient with AD, the head and neck areas can be especially difficult to manage and the use of medium to high potency topical corticosteroids (TCS) is not recommended.² Tralokinumab, a high affinity monoclonal antibody targeting interleukin-13, has been approved in multiple countries for the treatment of moderate to severe AD. ECZTEND is an ongoing open-label trial investigating the long-term safety and efficacy of the drug plus option TCS.

Methods and Materials

According to the analysis, data were retrieved from all patients on tralokinumab in ECZTRA 1 and 2 for 52 weeks who then enrolled in the long-term open-label study ECZTEND for up to an additional152 weeks. Eczema Area and Severity Index (EASI) scores were collected as a composite of intensity (0 to 3) and extent of involvement (0 to 6). Researchers also calculated head and neck regional scores (H&N EASI; 0 to 7.2) with the intensity of signs (erythema, induration/papulation, excoriation, lichenification) were assessed individually (0 to 3) and were summated (0 to 12) and multiplied by extent of involvement (0 to 6). The percent body surface area (BSA) weighting coefficient was used.

At baseline, researchers stated that patients generally exhibited substantial disease severity. They reported that 87.8% of patients had H&N involvement at baseline (H&N EASI>1) and the median treatment duration was 53.1 weeks. The max was reported to be 238.5 weeks. According to the analysis, the most common reasons for discontinuation were lack of efficacy (11.9%), other reasons (9.8%), adverse events (6.6%), withdrawal by subject (7.2%), and lost to follow up (4.2%).

Results

The analysis found that patients treated with tralokinumab for up to a total of 4 years had a reduced median H&N EASI from 3.0 at baseline to 0.2 at week 152. At that time, the proportion of patients with H&N EASI of ≤1 was reported to be 87.2%. In the most severe subgroup with investigator’s global assessment (IGA) 4 and high H&N involvement at baseline (n = 301), the median H&N EASI was reduced from 5.4 at baseline to 0.4 at week 152.

Researchers reported that the median total EASI (0 to 72) was improved from 28.2 at baseline to 1.3 at week 152. The proportion of patients with EASI ≤7 and EASI ≤2at week 152 were 86.5% and 58.3%, respectively.

Conclusion

Through this analysis, researchers found tralokinumab provided sustained improvements of head and neck regions in patients with moderate to severe AD for up to 4 years. Similarly, they noted sustained improvements were seen in severe patients with “substantial” head and neck involvement at baseline.

“Improvements in head and neck regions were comparable to overall EASI improvement,” the poster stated, a sign of success in this difficult to treat area.

References

1. Chovatiya R, Wollenberg A, Ribero S, et al. Improvement of the head and neck regions with continuous tralokinumab treatment for up to 4 years in adults with moderate to severe atopic dermatitis. Poster presented at the 2024 European Academy of Dermatology and Venereology Congress. Amsterdam, Netherlands, September 25 to 28, 2024.
2. Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20. doi:10.1016/j.jaad.2022.12.029