9 Months of Treatment With Tralokinumab Results in Improved QoL, Itch, and Sleep

Nine months of treatment with tralokinumab (Adbry; LEO Pharma) resulted in improvements in itch, sleep quality, and overall quality of life among adult patients with atopic dermatitis (AD), according to interim results from the TRACE study.¹

The results, presented in a poster² at the 2024 European Academy of Dermatology and Venereology Congress in Amsterdam, Netherlands, September 25-28, were similar among patients with and without a prior history of treatment with dupilumab (Dupixent; Regeneron and Sanofi).

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Background and Methods

TRACE is a prospective, non-interventional study involving 824 patients across 11 countries spanning 167 sites. The study, carried out over the course of 12 months, involved adult patients aged 18 years and older with a diagnosis of AD. Participants were required to be tralokinumab-naive, with an expectation to receive at least 1 dose during the study duration.

Individuals involved in the active treatment phase of another clinical trial, or who were previously involved in TRACE, were excluded from participation. Patients were enrolled between November 2021 and July 2023, with a data cut off of October 15, 2023.

Findings

At baseline, 627 patients were considered dupilumab-naive, while 197 entered the study with a prior history of treatment with dupilumab. The average age of participants was 44.1 years of age, with just over half (52.2%) of patients being male. The majority of participants (75.7%) were White, with Asian (5.3%), Black or African American (4.5%), and patients of multiple or unknown ethnicities (14.4%) also represented.

The average body mass index (BMI) of dupilumab-naive patients was 26.6 kg/m², with an average BMI of 27.7 kg/m² in the dupilumab-experienced patient cohort. The average Eczema Area and Severity (EASI) scores for dupilumab-naive and experienced patients was 20.9 and 16.9, respectively.

Significantly more patients in both cohorts had an Investigator Global Assessment score of 3, with fewer having a score of 4 at baseline. Peak Pruritus Numerical Rating Scale (PP-NRS) scores were also comparable, being 6.6 in naive patients and 5.5 in experienced patients. Dermatology Life Quality Index (DLQI) scores for naive and experienced patients were 13.4 and 10.7, respectively, with sleep NRS scores being 5.2 and 4.4, also respectively.

Researchers assessed patients at 3, 6, and 9 months in follow-up visits. Over time, average PP-NRS, DLQI, and sleep NRS scores all gradually demonstrated improvement.

At month 3, the average PP-NRS had decreased to 4.2, then to 3.5 and 3.3 at months 6 and 9. Average DLQI scores also improved significantly over time, decreasing from 7.0 at month 3 to 5.7 and 5.4 at months 6 and 9. Sleep NRS scores demonstrated a similar pattern of improvement, being recorded as 2.8, 2.2, and 2.2 at months 2, 6, and 9.

The overall proportion of patients achieving PP-NRS ≤ 4 improved from 23% to 52% by month 3, then improved further to 68% at month 6 and 72% at month 9.

Similarly, the proportion of patients achieving DLQI ≤ 5 increased from 20% to 49% by month 3, then continued improving to 64% at month 6. At month 9, this measure remained the same, indicative of continued stability.

Conclusions

"Treatment up to 9 months with tralokinumab improved AD patient-reported itch, QoL, and sleep quality in a real-world setting," according to poster authors Costanzo et al.

References

1. Armstrong AW, Rubin C, Jarell A, et al. Tralokinumab real-world use in adults with atopic dermatitis: baseline characteristics of the first 100 patients recruited to the TRACE study in the United States. Br J Dermatol. February 2024. https://doi.org/10.1093/bjd/ljad498.056
2. Costanzo A, Becherel PA, Serra-Baldrich E, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: interim data on improvements in patient-reported outcomes after up to 9 months of follow-up in the TRACE study. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, Netherlands.