Disproportionality Analysis Of Vedolizumab to Identify a Putative Signal Using Real-World Postmarketing Surveillance Data Reported in the FAERS Database
Author(s)
Purnima kumari, PharmD.
Student (Intern), MS Ramaiah University of Applied Science, Bengaluru, India.
Student (Intern), MS Ramaiah University of Applied Science, Bengaluru, India.
OBJECTIVES: The study aimed to identify the novel signals of enfuvirtide reported within the USFDA Adverse Event Reporting System (FAERS) database
METHODS: An in-depth case/non-case retrospective disproportionality analysis was conducted in the publicly available FAERS database for Vedolizumab. It was approved by FDA on May 20, 2004. All the reports of Vedolizumab were analysed. The investigation delved into the USFDA adverse event reporting system database, employing the top 2 data mining algorithms in widespread use for signal detection such as Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) from the OpenVigil database. A value of PRR≥2 and ROR-1.96SE>2 was considered as positive signal.
RESULTS: A total of 30,668,520 FAERS reports were documented for Vedolizumab. After data cleansing, 67,726 reports related to Vedolizumab were utilized for analysis. The Vedolizumab had 58,121 serious and 3,024 fatal reactions. The novel signal identified for Vedolizumab is Bell’s Palsy. The total number of adverse events reported for Bell’s Palsy is 22. On analysis, data mining algorithms showed the results as ROR of 8.59(5.627; 13.121) and PRR of 8.588(5.626; 13.111). The ROR and PRR confirmed the occurrence of the adverse reaction plagiocephaly for Vedolizumab.
CONCLUSIONS: This study revealed novel risk signal and important insights on Vedolizumabassociated Bell’s Palsy. The authors conclude that the health care practitioners should monitor for the occurrence of Bell’s Palsy among patients. The epidemiological studies should be conducted to validate the putative signal in real-world scenarios among the patients administered with Vedolizumab to improve patient safety.
METHODS: An in-depth case/non-case retrospective disproportionality analysis was conducted in the publicly available FAERS database for Vedolizumab. It was approved by FDA on May 20, 2004. All the reports of Vedolizumab were analysed. The investigation delved into the USFDA adverse event reporting system database, employing the top 2 data mining algorithms in widespread use for signal detection such as Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) from the OpenVigil database. A value of PRR≥2 and ROR-1.96SE>2 was considered as positive signal.
RESULTS: A total of 30,668,520 FAERS reports were documented for Vedolizumab. After data cleansing, 67,726 reports related to Vedolizumab were utilized for analysis. The Vedolizumab had 58,121 serious and 3,024 fatal reactions. The novel signal identified for Vedolizumab is Bell’s Palsy. The total number of adverse events reported for Bell’s Palsy is 22. On analysis, data mining algorithms showed the results as ROR of 8.59(5.627; 13.121) and PRR of 8.588(5.626; 13.111). The ROR and PRR confirmed the occurrence of the adverse reaction plagiocephaly for Vedolizumab.
CONCLUSIONS: This study revealed novel risk signal and important insights on Vedolizumabassociated Bell’s Palsy. The authors conclude that the health care practitioners should monitor for the occurrence of Bell’s Palsy among patients. The epidemiological studies should be conducted to validate the putative signal in real-world scenarios among the patients administered with Vedolizumab to improve patient safety.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD67
Topic
Epidemiology & Public Health, Methodological & Statistical Research, Real World Data & Information Systems
Topic Subcategory
Data Protection, Integrity, & Quality Assurance
Disease
Gastrointestinal Disorders