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Introduction <p>Skin infections are a common concern in the treatment of atopic dermatitis (AD) with topical medications including topical corticosteroids (TCS), tacrolimus, delgocitinib, and difamilast. However, real-world evidence regarding the incidence of these infections across different topical medications remains limited. This study aimed to evaluate patient characteristics and the incidence rates of skin infections associated with topical medications using Japanese claims data.</p> Methods <p>We conducted a retrospective cohort study using health insurance claims data from June 2022 to June 2023. Patients with AD were classified into three treatment groups: difamilast, TCS, and non-TCS (tacrolimus and delgocitinib). Incidence rates of skin infections were calculated using the person-year method (1000 person-years). Propensity score matching was used to compare treatment groups.</p> Results <p>Among 107,854 eligible patients, 1,844,45,988, and 8256 received difamilast, TCS, and non-TCS monotherapy, respectively. Before matching, the proportions of female patients were 59.8%, 51.7%, and 66.8% in the difamilast, TCS, and non-TCS groups, and the median ages were 19.0, 13.0, and 38.0&#xa0;years, respectively. After matching, the incidence rate of skin infections was 362.880/1000 person-years in the difamilast group, compared with 306.336/1000 person-years in the TCS group (risk ratio: 1.185; 95% confidence interval [CI] 0.934, 1.503). Compared with the non-TCS group, the risk ratio was 1.302 (95% CI 1.005, 1.686). No major differences were observed in the incidence of individual skin infections, except for acne. Among patients who received difamilast monotherapy, the incidence rate of skin infections (340.341/1000 person-years; 95% CI 285.209, 406.129) was consistent with the overall patients prescribed difamilast (349.819/1000 person-years; 95% CI 326.257, 375.084).</p> Conclusions <p>Difamilast demonstrated a comparable safety profile to other topical treatments regarding skin infections in patients with AD. These findings highlight the importance of monitoring infection risk and ensuring appropriate clinical management when prescribing topical medications for AD.</p>

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Incidence of Skin Infections in Patients with Atopic Dermatitis Treated with Topical Medications: A Cohort Study Using Japanese Claims Data

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  • 发表日期：

    2026年6月3日

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  • Akio Tanaka,
  • Rikiya Toda,
  • Takahiro Tsuchiya,
  • Yasuhito Konishi,
  • Miyuki Matsukawa,
  • Takeo Nakayama

摘要

Introduction

Skin infections are a common concern in the treatment of atopic dermatitis (AD) with topical medications including topical corticosteroids (TCS), tacrolimus, delgocitinib, and difamilast. However, real-world evidence regarding the incidence of these infections across different topical medications remains limited. This study aimed to evaluate patient characteristics and the incidence rates of skin infections associated with topical medications using Japanese claims data.

Methods

We conducted a retrospective cohort study using health insurance claims data from June 2022 to June 2023. Patients with AD were classified into three treatment groups: difamilast, TCS, and non-TCS (tacrolimus and delgocitinib). Incidence rates of skin infections were calculated using the person-year method (1000 person-years). Propensity score matching was used to compare treatment groups.

Results

Among 107,854 eligible patients, 1,844,45,988, and 8256 received difamilast, TCS, and non-TCS monotherapy, respectively. Before matching, the proportions of female patients were 59.8%, 51.7%, and 66.8% in the difamilast, TCS, and non-TCS groups, and the median ages were 19.0, 13.0, and 38.0 years, respectively. After matching, the incidence rate of skin infections was 362.880/1000 person-years in the difamilast group, compared with 306.336/1000 person-years in the TCS group (risk ratio: 1.185; 95% confidence interval [CI] 0.934, 1.503). Compared with the non-TCS group, the risk ratio was 1.302 (95% CI 1.005, 1.686). No major differences were observed in the incidence of individual skin infections, except for acne. Among patients who received difamilast monotherapy, the incidence rate of skin infections (340.341/1000 person-years; 95% CI 285.209, 406.129) was consistent with the overall patients prescribed difamilast (349.819/1000 person-years; 95% CI 326.257, 375.084).

Conclusions

Difamilast demonstrated a comparable safety profile to other topical treatments regarding skin infections in patients with AD. These findings highlight the importance of monitoring infection risk and ensuring appropriate clinical management when prescribing topical medications for AD.