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Seasonality and Pandemic-Era Trends in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Pharmacovigilance and Time-Series Analysis
Journal article   Open access

Seasonality and Pandemic-Era Trends in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Pharmacovigilance and Time-Series Analysis

Eric Milan Mukherjee, Dodie Park, Amir Asiaee, Matthew S. Krantz, Cosby A Stone, Jr, Michelle D Martin-Pozo and Elizabeth Phillips
Journal of Allergy and Clinical Immunology Global, In Press
2026
DOI: https://doi.org/10.1016/j.jacig.2026.100796
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Open Access CC BY-NC-ND V4.0

Abstract

Background Seasonal variation in adverse drug reactions may reflect changes in environmental exposures, prescribing, or host susceptibility. Objective Evaluate seasonality and pandemic-era trends in Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN). Methods We performed a cross-sectional pharmacovigilance study of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) from 2010-2023. Primary seasonality analysis used Northern Hemisphere reports with complete event dates from 2010-2019. Time series models trained on pre-pandemic data were used to generate counterfactual forecasts through December 2023 and evaluate the impact of the COVID-19 pandemic. Influenza, respiratory syncytial virus (RSV), and photosensitivity served as positive controls. Results Among 5,947 SJS/TEN reports, monthly and seasonal variation was not significant, and seasonality strength, assessed using Seasonal-Trend Decomposition using Loess (STL), was low (0.163). In contrast, influenza, RSV, and photosensitivity demonstrated robust seasonal patterns. During the pandemic, influenza and RSV fell substantially below forecasts, whereas SJS/TEN reporting remained near or modestly above expected levels. The magnitude of the SJS/TEN deviation was sensitive to the pre-pandemic training interval, with progressively later training windows yielding smaller observed-to-expected differences. Primary-suspect drug composition also shifted, and immune checkpoint inhibitor involvement increased substantially over time. Conclusion SJS/TEN demonstrated minimal seasonality despite strong seasonality in positive controls. These findings support a limited role for seasonal environmental exposures relative to host susceptibility and drug-specific risk, while highlighting the importance of evolving treatment patterns when interpreting pharmacovigilance trends. The increasing representation of ICIs among SJS/TEN reports further highlights the importance of evolving therapeutic landscapes when interpreting long-term pharmacovigilance trends.

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