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The following is a summary of “A Scalable Approach to Assess the Safety of Recently Marketed Systemic Treatments for Atopic Dermatitis in Clinical Practice: First Analysis Cycle of a Sequential Monitoring System,” published in the May 2025 issue of Journal of Investigative Dermatology by Schneeweiss et al. 

Targeted systemic immunomodulating drugs (IMD) showed high efficacy in randomized controlled trials (RCT), but limited sample sizes raised concerns about their safety.  

Researchers conducted a retrospective study to develop a data and analytics framework for generating timely, high-quality evidence on the comparative safety of recently approved IMDs in adults with atopic dermatitis (AD).  

They created sequential cohorts balanced by propensity scores (PS), which expanded with each annual data update. A total of 9 health outcomes of interest were included, along with conjunctivitis as a positive tracer outcome. The initial comparison evaluated dupilumab IL-4/13 and tralokinumab IL-13 against abrocitinib and upadacitinib (both Jak inhibitors).  

The results showed that the first analysis cycle (December 2021–February 2023) included 269 individuals who started Jak inhibitors and 2,650 who began IL-4/13 inhibitors. After PS matching, baseline characteristics were balanced. Outpatient infections within 180 days occurred in 18% of Jak1 inhibitor users compared to 12% of IL-4/13 inhibitor users (risk ratio = 1.50, 95% CI = 0.96–2.33). Acne was reported in 7% vs 3%, respectively (risk ratio = 2.29, 95% CI = 0.96–5.46).  

Investigators concluded that the sequential monitoring system produced essential knowledge on the safety of IMDs for atopic dermatitis based on its growing study size in clinical practice. 

Source: jidonline.org/article/S0022-202X(24)02169-9/abstract