| アブストラクト | Reports of cutaneous lymphomas (CL) following dupilumab administration are increasingly being documented, most frequently in patients with atopic dermatitis (AD). However, information regarding the association between CL and other biologic agents (nemolizumab, tralokinumab, or lebrikizumab) used for the treatment of AD is limited. To date, no large-scale pharmacovigilance study has systematically evaluated this issue in Japan. Therefore, we conducted a case investigation and disproportionality analysis using the Japanese Adverse Drug Event Report (JADER) database. Reports registered between April 2004 and August 2025 were analyzed. Both frequentist and Bayesian disproportionality analyses were performed using the reporting odds ratio (ROR) and information component (IC). In the primary analysis, including all reports in the JADER database, the ROR for dupilumab was 257.64 (95% confidence interval [CI], 164.50-404.39), and the IC was 4.52 (IC(025) = 3.89). For nemolizumab, the ROR was 169.13 (95% CI, 61.78-463.00), and the IC was 2.29 (IC(025) = 0.95). Reports of CL following tralokinumab or lebrikizumab administration were rare (one and zero cases, respectively) and did not meet the criteria for ROR calculation due to the small number. For sensitivity analysis, disproportionality analyses were restricted to reports with available data on age and sex, submitted by physicians, and cases involving no other suspected drugs. Under these conditions, safety signals based on both the ROR and IC were detected only for dupilumab. The safety signals identified in this study are exploratory in nature and require confirmation in future epidemiological studies. |
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