Identifying New Candidate Predictors of Mortality in Japanese Patients with Severe Drug Eruptions

Shiho Sato (), Tadao Ooka, Yoshito Zamami, Hirofumi Hamano, Fumikazu Hayashi, Eri Eguchi, Narumi Funakubo and Tetsuya Ohira
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Shiho Sato: Fukushima Medical University School of Medicine
Tadao Ooka: University of Yamanashi
Yoshito Zamami: Medical Development Field
Hirofumi Hamano: Medical Development Field
Fumikazu Hayashi: Fukushima Medical University School of Medicine
Eri Eguchi: Fukushima Medical University School of Medicine
Narumi Funakubo: Fukushima Medical University School of Medicine
Tetsuya Ohira: Fukushima Medical University School of Medicine

Drug Safety, 2025, vol. 48, issue 11, No 6, 1243-1251

Abstract: Abstract Background and Objectives SCORe of Toxic Epidermal Necrolysis (SCORTEN) and ABCD-10 have been developed as scoring systems for predicting mortality associated with Stevens–Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). These scores were developed based on a small number of patients; hence, their generalizability requires further exploration. The present study used three algorithms, including a machine learning method, to construct a mortality prediction model for SJS/TEN and to identify new candidate predictors of mortality from severe drug eruptions. Methods Data from 5966 patients with SJS or TEN were extracted from the Japanese Adverse Drug Event Report Database. A mortality prediction model was then constructed using stepwise regression, L1 regularized-logistic regression, and random forests based on the patient characteristics (e.g., age, sex, primary disease, adverse events, drug classification, route of administration) and outcomes (death). Results and Discussion The mortality prediction models for SJS/TEN identified sex (men), primary disease (hyperlipidemia, diabetes mellitus, renal dysfunction, and malignant tumors), adverse events (renal dysfunction, liver dysfunction, respiratory dysfunction, bacteremia/sepsis, disseminated intravascular coagulation syndrome, shock, and multiple organ failure), number of concomitant drugs, and route of administration (injection) as common factors associated with mortality. Conclusions Our findings showed that sex, hyperlipidemia as the primary disease, number of concomitant drugs, use of antipyretic analgesics, and route of administration may be considered as predictors of mortality in patients with SJS/TEN. The external validity of these factors needs to be examined in the future.

Date: 2025
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DOI: 10.1007/s40264-025-01572-3

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