EFFICACY AND SAFETY EVALUATION IN EUROPE OF BEDINVETMAB, A NOVEL MONTHLY MONOCLONAL ANTIBODY THERAPY FOR THE TREATMENT OF OSTEOARTHRITIS PAIN IN CLIENT-OWNED DOGS

Type:
Free Communication
Topic:
Orthopaedics
Companies:
(1) Zoetis Belgium SA, VMRD, Mercuriusstraat 20, 1930 Zaventem, Belgium
(2) Zoetis Inc., VMRD, 333 Portage Street, Kalamazoo, MI 49007, USA
Authors:
Maria J. Corral (1)
Hilde Moyaert (1)
Monica Escalada (1)
Jezaniah Kira S. Tena (2)
Rodney R. Walters (2)
Michael R. Stegemann (1)
Paper:
RESUMEN CORTO - SHORT SUMMARY

Bedinvetmab is a canine monoclonal antibody targeting Nerve Growth Factor (NGF). The inhibition of NGF mediated cell signalling has demonstrated to relieve pain associated with osteoarthritis (OA). The objective of the study was to determine the efficacy and safety of bedinvetmab for the treatment of pain associated with OA. Dogs with OA (n=287) were enrolled from 26 veterinary practices in four EU countries.  Dogs were randomized to subcutaneous treatment with placebo (saline, n=146) or bedinvetmab (0.5-1.0 mg/kg, n=141) administered on Days 0, 28 and 56. The primary endpoint was treatment success based on the owner-assessed Canine Brief Pain Inventory (CBPI). Treatment Success was defined as a reduction of ≥1 in CBPI Pain Severity Score and ≥2 in CBPI Pain Interference Score vs Day 0.  Percent treatment success was significantly greater in the bedinvetmab-treated group vs the placebo-treated group at all time points (P≤0.0025). On Day 28, 43.5% of dogs achieved treatment success with bedinvetmab compared to placebo (16.9%) (P=0.0017). Treatment success continued through Days 56 (50.8%) and 84 (48.2%) in the bedinvetmab-treated group and was < 25% in the placebo-treated group at all time points. Withdrawals for lack of efficacy were greater in the placebo-treated (n=21) compared to the bedinvetmab-treated group (n=3). Treatment-induced immunogenicity was found in 1.4% of bedinvetmab-treated dogs. Adverse events were similar in frequency between treatment groups and considered typical for a population of OA dogs. This study demonstrated the safety and efficacy of bedinvetmab in the population treated when administered monthly (0.5-1.0 mg/kg, SC) for three months.



BIBLIOGRAFÍA

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