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

Federica Fraenza,

Cecilia Cagnotta,

Mario Gaio

et al.

Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)

Published: April 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.

Language: Английский

Communication and Therapy Planning for Patients of Reproductive Age under Immunomodulatory Treatments for Psoriasis or Psoriatic Arthritis—Survey of the German National Psoriasis Registry PsoBest DOI Open Access
Brigitte Stephan, Christina Sorbe, Birgit‐Christiane Zyriax

et al.

Healthcare, Journal Year: 2025, Volume and Issue: 13(9), P. 1017 - 1017

Published: April 28, 2025

Background/Objective: During the systemic treatment of moderate to severe psoriasis in patients reproductive age, contraindications and therapeutic peculiarities must be taken into account. Doctor–patient communication is crucial for therapy conduct compliance. Methods: This survey among male female from German registry, PsoBest, aims provide real-world evidence on patient needs those age (18–55). Result: In total, 404 were eligible analysis (254 m, 150 f), including 39 currently wishing conceive (20 19 f). Patients with without desire have children received similar therapy. most cases, was not adapted when expressed a (85.9% 79.5% Only 38.3% men 49.9% women had been informed about options conception during or before therapy, mainly by dermatologists (77.4% 84.6% The majority retrieved additional information wish medications internet other media. emphasizes importance open between physicians regarding family planning options. Conclusions: Physicians need broach topic planning, pregnancy support evidence-based enable comprehensive medical decision making safe choices.

Language: Английский

Citations

0

Use of biologics to treat asthma during pregnancy and adverse events in pregnant women and newborns: A global pharmacovigilance analysis DOI Creative Commons
Wonwoo Jang,

Hyesu Jo,

Jaeyu Park

et al.

International Archives of Allergy and Immunology, Journal Year: 2025, Volume and Issue: unknown, P. 1 - 21

Published: Jan. 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.

Language: Английский

Citations

0

A Guide to the Management of Hidradenitis Suppurativa in Pregnancy and Lactation DOI Creative Commons

Raveena Ghanshani,

Katrina Lee,

Ashley Crew

et al.

American Journal of Clinical Dermatology, Journal Year: 2025, Volume and Issue: unknown

Published: March 25, 2025

Language: Английский

Citations

0

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

Federica Fraenza,

Cecilia Cagnotta,

Mario Gaio

et al.

Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)

Published: April 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.

Language: Английский

Citations

0