Retrospective Analysis of the Trends in Adverse Event Reporting for BRAF Inhibitors, MEK Inhibitors, and Immune Checkpoint Inhibitors from 2012-2021

Author(s)

Mullins K
University of Cincinnati College of Pharmacy, Cincinnati, OH, USA

Annually, invasive cases of melanoma have increased by 44% in the past decade (2011-2021), making the treatment of melanoma a top health priority. Immunotherapies and BRAF/MEK inhibitors used either alone or in combination have become the standard of care for stage III/IV BRAF mutant melanoma. Clinical trial data may not fully reflect the adverse event (AE) profiles due to the inherent lack of follow-up, relatively small sample sizes, and limited study duration. A retrospective, descriptive analysis was conducted to determine the adverse events, immune related adverse events (irAEs), and outcomes (death, life-threatening, hospitalization, and disability) associated with BRAF/MEK inhibitors and immune checkpoint inhibitors (ICI’s) using the FDA Adverse Event Reporting System (FAERS) database. The data obtained from the BRAF/MEK inhibitors (dabrafenib, trametinib, vemurafenib, cobimetinib, encorafenib, binimetinib) and the ICI’s (nivolumab, atezolizumab, ipilimumab, pembrolizumab) were compared between the classes. Most reports (42% for BRAF/MEK inhibitors, 54% for ICIs) were male and the average age was 60 years. AE’s associated with dabrafenib and trametinib were the most frequently reported for BRAF/MEK inhibitors while nivolumab AE’s were most frequent amongst the ICI’s. We found 195,640 unique AE reports associated with BRAF/ MEK inhibitor usage and 491,138 unique AE reports associated with ICI usage. Amongst the medications studied, the following AE’s were common: malignant neoplasm progression, death, diarrhea, pyrexia, fatigue, and rash. The most reported outcomes for all drugs were hospitalization and death. IrAE’s had low rates across the ICIs; however, ipilimumab had much higher incidences of GI AE’s and hypophysitis in comparison to the other drugs. Due to the severity of the AE’s reported, healthcare professionals should be made aware of the AE profiles attributable to the studied drugs.

Conference/Value in Health Info

2022-05, ISPOR 2022, Washington, DC, USA

Value in Health, Volume 25, Issue 6, S1 (June 2022)

Code

RWD132

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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