Musculoskeletal adverse events in dogs receiving bedinvetmab (Librela)
Mike Farrell, Felix W. A. Waibel, Ines Carrera, Giliola Spattini, Louise Clark, Robert J. Adams, Dirsko J. F. von Pfeil, Ricardo J. R. De Sousa, Diego Bobis Villagrà, Maria Amengual-Vila, Annalisa Paviotti, Robert R. Quinn, Justin Harper, Stephen P. Clarke, C. J. Jordan, Michael Hamilton, A. P. Moores, Mark Irwin Greene
Abstract
Objectives: To conduct a specialist-led disproportionality analysis of musculoskeletal adverse event reports (MSAERs) in dogs treated with bedinvetmab (Librela™) compared to six comparator drugs with the same indication. Furthermore, to report the findings from a subset of dogs whose adverse event (AE) data underwent independent adjudication by an expert panel. Study design: Case-control study and case series analysis. Sample population: The European Medicines Agency's EudraVigilance database (2004-2024) and 19 client-owned dogs. Methods: (2004-2024). The primary null hypothesis was that Librela's MSAER rate would not exceed that of comparator drugs by more than 50%. The secondary hypothesis was that MSAER would surge and taper following the launch of new drugs. Results: The disproportionality analysis did not support the hypotheses. Ligament/tendon injury, polyarthritis, fracture, musculoskeletal neoplasia, and septic arthritis were reported ~9-times more frequently in Librela-treated dogs than the combined total of dogs treated with the comparator drugs. A review of 19 suspected musculoskeletal adverse events (MSAEs) by an 18-member expert panel unanimously concluded a strong suspicion of a causal association between bedinvetmab and accelerated joint destruction. Conclusion: This study supports recent FDA analyses by demonstrating an increased reporting rate of musculoskeletal adverse events in dogs treated with Librela. Further investigation and close clinical monitoring of treated dogs are warranted. Impact: Our findings should serve as a catalyst for large-scale investigations into bedinvetmab's risks and pharmacovigilance.