Researchers for a new analysis have provided a data and analytics framework for the evaluation of the safety of immune-modulating drugs (IMDs) in treating atopic dermatitis (AD).
The study authors designed the system to generate timely, high-quality evidence using sequential propensity score-balanced cohorts to compare newly approved IMDs. The first analysis, covering data from December 2021 to February 2023, included 269 patients initiating treatment with JAK inhibitors (abrocitinib or upadacitinib) and 2,650 patients initiating IL-4/IL-13 inhibitors (dupilumab or tralokinumab).
Following propensity score-matching, patient characteristics were balanced between the groups. In the first 180 days of treatment, 18% of patients taking JAK inhibitors experienced outpatient infections, compared with 12% of those on IL-4/IL-13 inhibitors (RR = 1.50). The risk of acne was also higher in the JAK inhibitor group (7% vs. 3%, RR = 2.29).
This ongoing, real-world monitoring system will provide essential safety insights as more patients are observed and the study size increases with each annual data update.
"The estimated effect sizes from this first analysis cycle are still too imprecise to draw actionable conclusions for clinical practice," the authors wrote in the study. "As the system is growing over time it will inform clinicians of the magnitude of unintended effects in clinical practice that are known from trials and may refute or identify signals that were not observable in the smaller trials."
Source: Schneeweiss M, et al. Journal of Investigative Dermatology. 2024. Doi:10.1016/j.jid.2024.08.034