| アブストラクト | INTRODUCTION: Despite the increasing evidence supporting the use of biologics for treating severe asthma, there is a lack of evidence regarding their use in pregnant women. This study aims to evaluate the safety of biologics for pregnant women, utilizing global pharmacovigilance database. METHODS: Reports documented between 1980 and 2023 were extracted from the VigiBase that mentioned pregnancy- or fetus-related reactions with drugs indicated for asthma, including reslizumab, omalizumab, mepolizumab, dupilumab, benralizumab, and other non-biologics. A disproportionality analysis of case-non-case was conducted by calculating the reporting odds ratio (ROR) with 95% confidence interval (95% CI) of adverse maternal, fetal, and newborn outcomes associated with exposure to biologics compared with outcomes associated with other non-biologic asthma medications. RESULTS: A total of 15,715 pregnancy-related reports were analyzed. Reslizumab showed an overall lower reporting frequency of adverse events (ROR, 0.19; 95% CI, 0.05-0.67). Omalizumab (ROR, 3.88; 95% CI, 3.16-4.77), mepolizumab (ROR, 1.87; 95% CI, 1.05-3.36), and dupilumab (ROR, 5.34; 95% CI, 3.90-7.32) commonly showed higher frequencies of spontaneous fetal death. However, these three drugs also had lower frequencies of pregnancy and delivery complications, including preterm birth (omalizumab: ROR, 0.22; 95% CI, 0.16-0.31; mepolizumab: ROR, 0.10; 95% CI, 0.03-0.34; dupilumab: ROR, 0.07; 95% CI, 0.03-0.17), which are outcomes related to late pregnancy. In contrast, benralizumab (ROR, 0.69; 95% CI, 0.48-0.99) differed from the other biologics by showing lower frequencies of spontaneous fetal death (ROR, 0.69; 95% CI, 0.48-0.99) and spontaneous abortion (ROR, 0.47; 95% CI, 0.29-0.78) but higher frequencies of delivery complications (ROR, 1.32; 95% CI, 1.02-1.72), including preterm birth (ROR, 1.46; 95% CI, 1.14-1.86). CONCLUSIONS: This global case-non-case study underscores the critical need for further well-designed research to investigate these overreported outcomes and emphasizes the importance of more rigorous monitoring efforts for these adverse events. |
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| ジャーナル名 | International archives of allergy and immunology |
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| Pubmed追加日 | 2025/1/20 |
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| 投稿者 | Jang, Wonwoo; Jo, Hyesu; Park, Jaeyu; Kim, Seokjun; Cho, Hanseul; Jeong, Yi Deun; Son, Yejun; Pizzol, Damiano; Papadopoulos, Nikolaos G; Yon, Dong Keon |
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| 組織名 | Center for Digital Health, Medical Science Research Institute, Kyung Hee;University Medical Center, Kyung Hee University College of Medicine, Seoul,;Republic of Korea.;Department of Medicine, Kyung Hee University College of Medicine, Seoul, Republic;of Korea.;Department of Regulatory Science, Kyung Hee University, Seoul, Republic of Korea.;Health Unit Eni, Maputo, Mozambique.;Health Unit Eni, San Donato Milanese, Italy.;Allergy Department, Second Paediatric Clinic, National and Kapodistrian;University of Athens, Athens, Greece.;Division of Infection, Immunity and Respiratory Medicine, School of Biological;Sciences, The University of Manchester, Manchester, UK.;Department of Pediatrics, Kyung Hee University Medical Center, Kyung Hee;University College of Medicine, Seoul, Republic of Korea. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39827867/ |
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