Dupilumab for Atopic Dermatitis Sustained Efficacy in Clinical Signs, PROs Over 3 Years

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Treatment of atopic dermatitis with dupilumab therapy over 3 years sustains efficacy in patient-reported outcomes (PROs) and clinical signs, new findings suggest, with tolerable levels of safety among Japanese patients with the inflammatory skin condition.¹

These data were the conclusion of new research conducted in Japan within a single center, with assessments of patients occurring between 2018 - 2020. Hideyuki Nakajima, from the department of dermatology at Teikyo University School of Medicine in Tokyo, led the team of investigators who authored this research.

Nakajima et al. highlighted that despite the accumulated real-world data on dupilumab’s efficacy and on patient-reported outcomes over the short term, there has been limited real-world information on the medication’s long-term utilization lasting more than 2 years.²

“No real-world data on long-term usage of dupilumab by Japanese patients with [atopic dermatitis] have been reported,” Nakajima and colleagues wrote. “In this study, we retrospectively investigated its effectiveness and safety from laboratory data in patients with [atopic dermatitis] who received dupilumab for 3 years.”¹

Trial Design Details

The investigators noted that study subjects had been treated using an initial 600 mg dose of dupilumab, which was later followed by a 300 mg-dose administered subcutaneously on a basis of every 2 weeks. The process was also accompanied by topical therapies, some of which included tacrolimus, corticosteroids, delgocitinib, and/or difamilast.

The research team highlighted that participants who either stopped implementing dupilumab within the 3-year timeframe or extended their interval between treatment doses past 4 weeks were not assessed in their analysis. Atopic dermatitis severity was evaluated through the use of affected body surface area (BSA), Investigator’s Global Assessment (IGA), and Eczema Area and Severity Index (EASI) scores.

The investigative team evaluated subjects’ blood samples and assessed their serum levels of different biomarkers such as lactate dehydrogenase (LDH), thymus and activation-regulated chemokine (TARC), immunoglobulin E (IgE), as well as counts of participants’ white blood cells and platelets. The team looked into levels of pruritus, or itch, using the visual analog scale (VAS) and quality of life with the Dermatology Life Quality Index (DLQI) as well as the Patient-Oriented Eczema Measure (POEM).

In the aforementioned blood tests, the investigators conducted their evaluations at baseline, and then later at intervals of 3 months, 1 year, 2 years, and 3 years following dupilumab initiation.

Notable Findings

The research team evaluated the medication among a total of 60 Japanese individuals known to have atopic dermatitis, with 12 women and 48 men included and the average age being 36.6 years, with a standard deviation of 11.0. Additionally, the team noted that initial EASI scores among the subjects averaged 29.9, with a standard deviation of 9.2.

In clinical severity measures such as EASI, IGA, body surface area (BSA) affected, and PROs such as the Dermatology Life Quality Index (DLQI), POEM, and VAS for itch, improvements were observed. Such results were noted by the investigators at the 3-month mark and then continued through 1, 2, and 3 years after the medication’s initiation.

In participants’ EASI scores, marked reductions were noted given a mean decrease of 66.8% at the 3-month mark, 81.0% by the single-year mark, 85.3% at 2 years, and 90.0% at 3 were all reported by the investigative team. Substantial dips in participants’ serum levels of IgE, TARC, and lactate dehydrogenase (LDH) were also noted at the 1, 2, and 3-year marks.

Small neutrophil level reductions from 3 months onward were noted by the team with dupilumab, along with a significant dip in eosinophil counts at 2 and 3 years among subjects. In terms of adverse effects, the most common were eye-related and experienced by 38.3% of the participants.

“In conclusion, our study showed sustained effectiveness and tolerable safety during the 3-year usage of dupilumab by Japanese patients with [atopic dermatitis],” they wrote. “Furthermore, dupilumab decreased neutrophil values at 3 months and later, and reduced the number of circulating eosinophils after long-term use (≧ 2 years).”²

References

1. ^{Nakajima H, Kamata M, Okada Y, Suzuki S, Ito M, Watanabe A, Egawa S, Chijiwa C, Hiura A, Tomura Y, Fukaya S, Hayashi K, Fukuyasu A, Tanaka T, Ishikawa T, Tada Y. Real-World Experience of 3-Year Treatment With Dupilumab: Significant Decrease in Circulating Neutrophils and Eosinophils in Japanese Patients With Atopic Dermatitis. Exp Dermatol. 2024 Nov;33(11):e70010. doi: 10.1111/exd.70010. PMID: 39487715.}
2. ^{A. S. Halling, N. Loft, J. I. Silverberg, E. Guttman-Yassky, and J. P. Thyssen, “Real-World Evidence of Dupilumab Efficacy and Risk of Adverse Events: A Systematic Review and Meta-Analysis,” Journal of the American Academy of Dermatology 84 (2021): 139–147.}