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Incidence of Skin Infections in Patients with Atopic Dermatitis Treated with Topical Medications: A Cohort Study
Akio Tanaka1, Rikiya Toda2, Takahiro Tsuchiya2
1Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
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.
Insights
Difamilast shows a similar skin infection risk to topical corticosteroids (TCS) and other non-TCS treatments in atopic dermatitis (AD) patients. This study emphasizes monitoring infection risk with topical AD medications.
Area of Science:
- Dermatology
- Pharmacovigilance
- Real-world evidence
Background:
- Skin infections are a significant concern for atopic dermatitis (AD) patients using topical medications like topical corticosteroids (TCS), tacrolimus, delgocitinib, and difamilast.
- Limited real-world data exists on the comparative incidence of skin infections across these topical treatments.
Purpose of the Study:
- To evaluate patient characteristics and the incidence rates of skin infections associated with difamilast, TCS, and non-TCS (tacrolimus, delgocitinib) treatments in AD patients.
- To compare the real-world safety profiles of these topical medications concerning skin infection risk.
Main Methods:
- Retrospective cohort study utilizing Japanese health insurance claims data (June 2022-June 2023).
- Patients with AD were categorized into difamilast, TCS, and non-TCS groups.
- Incidence rates were calculated per 1000 person-years, with propensity score matching employed for group comparisons.
Main Results:
- After propensity score matching, difamilast showed a comparable incidence rate of skin infections to TCS (Risk Ratio: 1.185) and a slightly higher rate compared to non-TCS (Risk Ratio: 1.302).
- No significant differences in individual skin infection incidence were noted, except for acne.
- The incidence of skin infections in difamilast monotherapy patients aligned with the overall difamilast group.
Conclusions:
- Difamilast exhibits a comparable safety profile to other topical treatments concerning skin infections in AD patients.
- Findings underscore the necessity of monitoring infection risk and implementing appropriate clinical management for topical AD therapies.
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