This topic is part of a Volume II series following the success of the previous topic; 'Biologic Drugs in Immune-Mediated Inflammatory Diseases: Validation, Drug-Utilization, Effectiveness, Regulation, Costs, and Safety in the Real World',

Biologic drugs and vaccines represent a significant development in the treatment and prevention of a wide range of diseases, including immune-mediated inflammatory diseases (IMIDs) and infectious diseases. These therapeutic agents have revolutionized medical practice by targeting specific molecular pathways and stimulating immune responses, respectively. The increasing use of biologic drugs and vaccines in clinical settings requires continuous comprehensive real-world studies to evaluate their long-term safety, effectiveness, and economic impact across various disease states.

This Research Topic aims to investigate the real-world utilization, safety, effectiveness, and economic implications of biologic drugs for IMIDs and vaccines for infectious diseases. The prevalence of these conditions varies significantly and gender disparities in disease prevalence are observed, with certain conditions showing higher incidence in specific populations.

We address critical questions regarding the use of biologic drugs and vaccines in these clinical settings through real-world data analysis:

1. Data Source Validation: Evaluate the reliability and validity of data sources for exposure, outcomes, and disease-related variables.
2. Utilization Patterns: Assess persistence, adherence, switching, and discontinuation rates for biologics and vaccines.
3. Comparative Effectiveness: Analyze the real-world effectiveness of biologic drugs and vaccines compared to conventional approaches, including disease-specific endpoints and quality of life measures.
4. Safety Profiles: Investigate adverse events, hospitalizations, and emergency department admissions associated with biologic dugs and vaccine use across various patient populations.
5. Regulatory Implications: Examine the impact of real-world evidence on regulatory decision-making processes for biologic drugs and vaccines.
6. Pharmacoeconomic Analyses: Conduct comprehensive cost-effectiveness and budget impact analyses of biologic drugs and vaccines, including comparisons between originators and biosimilars.
7. Vaccine-specific Research: Evaluate vaccination coverage rates, effectiveness in preventing targeted diseases, and long-term safety profiles of various vaccine types.

We welcome all types of real-world studies, including but not limited to: Observational cohort studies, Case-control studies, Cross-sectional analyses, Time series analyses

Studies may focus on individual biologic drugs or vaccines, drug classes, or comparative analyses between different therapeutic options. Descriptive studies and those making direct comparisons between biologic drugs, biosimilars, vaccines, and conventional therapies are encouraged.

This research initiative will provide crucial evidence to support:
- Clinical decision-making by healthcare professionals
- Patient education and informed consent processes
- Policy-making and resource allocation by healthcare systems
- Regulatory affairs and post-marketing surveillance
- Development of real-world evidence for optimal use of biologic drugs and vaccines

By expanding the scope beyond biologic drugs used for IMIDs incorporating vaccines for infections, this research will contribute to a more comprehensive understanding of the real-world impact of these advanced agents used for therapeutic and prevention purposes across diverse patient populations and healthcare settings.

Ylenia Ingrasciotta is the CEO of the academic spin-off “INSPIRE srl” of the University of Messina, which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.) and from pharmaceutical Companies (Chiesi Italia, Kyowa Kirin s.r.l., Daiichi Sankyo Italia S.p.A.). All other Topic Editors declare no conflicts of interest.

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Biologic Drugs for immune-mediated inflammatory diseases (IMIDs) and Vaccines for infections: Validation, Drug-Utilization, Effectiveness, Regulation, Costs, and Safety in the real world