Safety Profile Of Anti-calcitonin Gene Related Peptide Monoclonal Antibodies: Protocol Of A Disproportionality Analysis Using The FDA Adverse Event Reporting System (FAERS) Database - Info and Reading Options

The Internet Archive:

Three anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs), namely erenumab, galcanezumab and fremanezumab, were approved by the Food and Drug Administration (FDA) in 2018 and by the European Medicines Agency (EMA) in 2019 as a treatment for the prevention of both episodic and chronic migraine. Recently, a novel anti-CGRP mAb, called eptinezumab was approved in 2020 by the FDA and in 2022 by the EMA. These drugs act by binding to CGRP, or its receptor, which plays a key role in arteriolar vasodilation and nociceptor sensitisation underlying migraine disease. Anti-CGRP mAbs have a long plasma half-life that allows for only monthly, or even quarterly, administration. Except from eptinezumab that is given by intravenous infusion, anti-CGRP mAbs are administered subcutaneously, which enables self-administration by the patient. In pre-registration trials, the most common adverse events reported with the use of anti-CGRP mAbs were: injection-site and hypersensitivity reactions, infections (e.g., nasopharyngitis, upper respiratory tract infection, sinusitis), gastrointestinal (e.g., nausea, constipation) and cardiovascular disorders (e.g., hypertension). Nevertheless, it must be taken into consideration that vulnerable subjects, such as the elderly, were not enrolled in clinical trials. Additionally, follow-up of pre-registration trials was limited to a maximum of 6 months, not sufficient to exclude long-term effects of CGRP blockade. In this context, post-marketing studies represent a fundamental source of information to address knowledge gaps about anti-CGRP mAbs safety. To date, few pharmacoepidemiological studies investigating the safety profile of this novel class of drugs have been performed using ad hoc data collection or electronic health care records database. Generally, the adverse events reported were mild to moderate. However, it should be noted that these studies included small samples and had short follow-up (12 months). Therefore, it is possible to suppose that these studies were more prone to not detect rare and long-term adverse events. Recently, some pharmacovigilance studies on anti-CGRP mAbs were published using the safety reports of suspected adverse drug reactions retrieved from the World Health Organization (WHO) pharmacovigilance database (VigiBase) and FDA Adverse Event Reporting System (FAERS). Findings from the aforementioned studies suggested that during the first 2 years of post-marketing surveillance, anti-CGRP adverse events reported were mostly non-serious and with a favourable prognosis. Additionally, these studies did not detect any safety signal when these drugs are used in pregnant women. It must be noted that no pharmacovigilance or pharmacoepidemiological safety studies on eptinezumab have been conducted to date as it was only recently marketed. Moreover, to our knowledge, no pharmacovigilance studies were published encompassing the 4 anti-CGRPs currently available on the market. Therefore, we designed a pharmacovigilance study on spontaneous reports from the FDA Adverse Event Reporting System to investigate the adverse events potentially associated with the use of the four anti-CGRP mAbs in the real-world setting.

Search for “Safety Profile Of Anti-calcitonin Gene Related Peptide Monoclonal Antibodies: Protocol Of A Disproportionality Analysis Using The FDA Adverse Event Reporting System (FAERS) Database” downloads:

Visit our Downloads Search page to see if downloads are available.

Find “Safety Profile Of Anti-calcitonin Gene Related Peptide Monoclonal Antibodies: Protocol Of A Disproportionality Analysis Using The FDA Adverse Event Reporting System (FAERS) Database” in Libraries Near You:

Read or borrow “Safety Profile Of Anti-calcitonin Gene Related Peptide Monoclonal Antibodies: Protocol Of A Disproportionality Analysis Using The FDA Adverse Event Reporting System (FAERS) Database” from your local library.

• The WorldCat Libraries Catalog: Find a copy of “Safety Profile Of Anti-calcitonin Gene Related Peptide Monoclonal Antibodies: Protocol Of A Disproportionality Analysis Using The FDA Adverse Event Reporting System (FAERS) Database” at a library near you.