Use of biologics to treat asthma during pregnancy and adverse events in pregnant women and newborns: A global pharmacovigilance analysis

International Archives of Allergy and Immunology, Год журнала: 2025, Номер unknown, С. 1 - 21

Опубликована: Янв. 17, 2025

Despite the increasing evidence supporting use of biologics for treating severe asthma, there is a lack regarding their in pregnant women. This study aims to evaluate safety women, utilizing global pharmacovigilance database. Reports documented between 1980 and 2023 were extracted from VigiBase that mentioned pregnancy- or fetus-related reactions with drugs indicated including reslizumab, omalizumab, mepolizumab, dupilumab, benralizumab, other non-biologics. A disproportionality analysis case-non-case was conducted by calculating reporting odds ratio (ROR) 95% confidence interval (95% CI) adverse maternal, fetal, newborn outcomes associated exposure compared non-biologic asthma medications. total 15,715 pregnancy-related reports analyzed. Reslizumab showed an overall lower frequency events (ROR, 0.19; CI, 0.05-0.67). Omalizumab 3.88; 3.16-4.77), mepolizumab 1.87; 1.05-3.36), dupilumab 5.34; 3.90-7.32) commonly higher frequencies spontaneous fetal death. However, these three also had pregnancy delivery complications, preterm birth (omalizumab: ROR, 0.22; 0.16-0.31; mepolizumab: 0.10; 0.03-0.34; dupilumab: 0.07; 0.03-0.17), which are related late pregnancy. In contrast, benralizumab 0.69; 0.48-0.99) differed showing death abortion 0.47; 0.29-0.78) but complications 1.32; 1.02-1.72), 1.46; 1.14-1.86). underscores critical need further well-designed research investigate over-reported emphasizes importance more rigorous monitoring efforts events.

Язык: Английский

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Disproportionality analysis of European safety reports on autoimmune and rheumatic diseases following COVID-19 vaccination

Scientific Reports, Год журнала: 2025, Номер 15(1)

Опубликована: Апрель 27, 2025

Abstract The safety profile of COVID-19 vaccines is well-established, yet the widespread immunization campaign has led to an increase in reported cases Immune-Mediated and Rheumatic Diseases (IMDRs). This study aimed assess reporting Adverse Events Following Immunization (AEFIs) related IMDRs after vaccination. We analyzed all individual case reports (ICSRs) authorized European Union (i.e., tozinameran, elasomeran, ChAdOx1-S NCoV-19, Ad26.Cov2.S) registered EudraVigilance (EV) database from January 1, 2021, October 23, 2023. Our analysis identified ICSRs with events indicative conducted disproportionality Reporting Odds Ratio (ROR) 95% CI) examine frequency different IMDR types linked each vaccine. In total, 45,352 at least one AEFI associated rheumatic or autoimmune conditions, 54% them implicating tozinameran as suspected More than half AEFIs were classified serious, approximately 45% remaining unresolved. most frequently conditions other immune-mediated diseases, followed by arthritis, vasculitis, systemic lupus erythematosus, tendinopathies. suggested that mRNA may be more new diseases. Stratified revealed significant associations for ChAd, particularly vasculitis tendinopathies, only when compared Ad26.Cov2.S. Real-world pharmacovigilance data suggest diseases under-reported following vaccination, highlighting need further research better understand underlying mechanisms. findings this studies investigate these results greater depth.

Язык: Английский

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Global and Regional Burden of Vaccine‐Associated Transverse Myelitis and Potentially Associated With Vaccines From 1967 to 2023: An Analysis of the International Pharmacovigilance Data

Journal of Medical Virology, Год журнала: 2025, Номер 97(6)

Опубликована: Июнь 1, 2025

ABSTRACT Limited data on the potential safety risk of vaccine‐associated transverse myelitis (TM) is available. Thus, we aimed to identify global burden and clinical features TM facilitate tailored monitoring adverse vaccine reactions. This study used from World Health Organization pharmacovigilance database, which contains over 35 million reports 140 countries. We extracted individual case 1967 2023. To investigate association between 19 vaccines TM, calculated reporting counts, reported odds ratios (ROR) with 95% confidence intervals (CI), information components (IC) IC 0.25 based Bayesian model. identified 2305 (male, n = 999 [43.34%]) 4007 all‐cause TM. Since first report in 2010, cumulative number has steadily increased, a significant increase after 2020 due emergence COVID‐19 mRNA vaccines. Most were associated (ROR, 42.62 [95% CI, 28.02–64.82]; IC, 4.46 [IC , 3.75]), albeit varying levels signal. Typhoid had highest signal [28.02–64.82]; [3.75]), followed by hepatitis A 38.04 [30.13–48.03]; 4.90 [4.51]), influenza 31.55 [28.17–35.32]; 4.80 [4.62]), encephalitis, papillomavirus, B Age‐ sex‐specific analyses indicated that increased age be more susceptible among males through ROR. The rate fatal outcomes was 0.22%. highlights detection onset comprising half all cases database. Although incidence remains low, clinicians should remain vigilant for symptoms following vaccination, particularly older adults where appears higher. While our findings do not permit causal inference, given increasing trend 2020, continued further research are needed ensure timely management risks while maintaining benefits immunization.

Язык: Английский

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Signal detection between 5-alpha reductase inhibitors and the risk of suicidality and depression: an international pharmacovigilance analysis

European Journal of Clinical Pharmacology, Год журнала: 2025, Номер unknown

Опубликована: Июнь 6, 2025

Язык: Английский

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