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Adverse events of interferon beta-1a: a prospective multi-centre international ICH-GCP-based CRO-supported external validation study in daily practice.

Author: , BormGeorge, FrequinStephan, HawkinsStanley, JongenPeter Joseph, LinssenWim, SandersEvert, SindicChristian, van MunsterErik

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Validation StudyResearch to assess the validity and reliability of new measurement methods or diagnostic tests.

Overview

Data on adverse events from interferon beta-1a treatment in daily practice were assessed using quality assurance measures similar to phase III trials.
Paper Details　
Original Abstract of the Article :
Due to methodological shortcomings the available post-registration data on the adverse events (AEs) occurring in interferon beta-1a (INFb-1a)-treated patients fail to adequately validate phase III data and only partially inform on safety in daily practice. We assessed AEs in relapsing remitting mult...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3201962/

データ提供：米国国立医学図書館（NLM）

Navigating the Side Effects of Interferon Beta-1a: A Journey Through the Desert of Adverse Events

Interferon beta-1a (INFb-1a) is a widely used treatment for relapsing remitting multiple sclerosis (RRMS), but it can come with a range of side effects. This study examines the adverse events (AEs) associated with INFb-1a treatment in daily practice, seeking to validate and expand upon data collected in clinical trials. The researchers used a prospective multi-center international study to collect data on AEs in RRMS patients treated with intramuscular (IM) INFb-1a in daily practice. They used data quality assurance measures similar to those employed in phase III trials to ensure the reliability of their findings.

The study found that the AEs observed in daily practice were generally consistent with those reported in phase III trials. The most common AEs were injection site reactions, flu-like symptoms, and depression. The study also highlighted the importance of monitoring patients for rare but serious AEs, such as hepatotoxicity and autoimmune disorders. The findings emphasize the need for careful patient monitoring and early intervention to manage AEs and optimize treatment outcomes.

The Desert of Side Effects: A Need for Careful Monitoring

This study underscores the importance of carefully monitoring patients receiving INFb-1a treatment. Early identification and management of AEs can help minimize their impact and ensure the best possible treatment outcomes.

A Journey Towards a Safer Future for Multiple Sclerosis Patients

This research provides valuable insights into the safety profile of INFb-1a in daily practice. It emphasizes the need for ongoing vigilance and a comprehensive approach to managing AEs to improve the lives of patients with RRMS.

Dr.Camel's Conclusion

This study provides a real-world perspective on the adverse events associated with INFb-1a treatment. It underscores the importance of careful patient monitoring and early intervention to manage AEs effectively and enhance the safety and effectiveness of this important therapy.

Date :
  1. Date Completed 2012-03-26
  2. Date Revised 2021-10-20
Further Info :

Pubmed ID

22046309

DOI: Digital Object Identifier

PMC3201962

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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