Safety of frunevetmab for osteoarthritis pain in cats

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.