What question did this study set out to answer?

To analyze adverse events associated with frunevetmab in cats using FDA database data.

February 12, 2026Journal of Veterinary Internal Medicine0 citationsOpen Access

Safety assessment of frunevetmab for osteoarthritis pain in cats: disproportionality analysis of the Food and Drug Administration Animal Drug Adverse Events database

XLXiaoheng LaiXiamen Chang Gung Hospital LLLi LinFujian Provincial Hospital YCYan ChenMacau University of Science and Technology

Key Points

To analyze adverse events associated with frunevetmab in cats using FDA database data.
Analyzed feline adverse event reports from the FDA ADAE database between January 2022 and December 2024.
Calculated measures including reporting odds ratio and proportional reporting ratio to assess disproportionality.
Identified significant adverse events across 24 system organ categories.
Analyzed 5,248 frunevetmab-specific adverse event reports.
Most frequent adverse events included pruritus, dermatitis, and unspecified skin disorders.
Detected unexpected adverse events, highlighting the need for enhanced monitoring.

Abstract

Abstract Background Frunevetmab is a felinized anti-nerve growth factor monoclonal antibody that alleviates osteoarthritis (OA) pain in cats by blocking nerve growth factor (NGF) signaling. While its efficacy is established, comprehensive real-world safety profiles remain limited. Hypothesis/Objectives To analyze frunevetmab-associated adverse events (AEs) using real-world data from the United States Food and Drug Administration (FDA) Animal Drug Adverse Events (ADAE) database. Animals Adverse event reports submitted for cats receiving frunevetmab, extracted from the FDA ADAE database (January 2022 - December 2024). Methods Disproportionality in frunevetmab-associated AEs was assessed by calculating the reporting odds ratio, the proportional reporting ratio, the Bayesian confidence-propagation neural network, and the multi-item gamma Poisson shrinker. Results From 33,378 feline AE reports, 5,248 frunevetmab-specific reports were analyzed. Frunevetmab-induced AEs spanned 24 system organ categories. Among the 19 significant preferred terms (PTs) identified, the most frequently reported AEs included pruritus, unspecified skin disorders, alopecia, dermatitis and eczema, and unspecified skin lesions. Notably, the AEs with the highest signal strength were skin ulceration, unspecified skin disorders, unspecified skin lesions, injection site pain, and dermatitis and eczema. In addition, unexpected significant AEs (e.g., abnormal cytology, arthritis, paresis) were detected, all of which were absent from the package insert. Conclusions and clinical importance We identified new potential AE signals for frunevetmab, emphasizing the need for robust clinical monitoring. Although these hypothesis-generating findings from disproportionality analysis require validation, they offer immediate, valuable guidance for veterinarians to optimize the safe use of this treatment in cats with OA.

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Cite This Study

Lai et al. (Thu,) studied this question.

synapsesocial.com/papers/698d6eeb5be6419ac0d54d63 https://doi.org/https://doi.org/10.1093/jvimsj/aalag003

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