A Randomized, Double-Blinded, Noninferiority Trial Evaluating the Efficacy of Bedinvetmab (Librela), a Fully Canine Anti-Nerve Growth Factor Monoclonal Antibody, Compared to Grapiprant for Osteoarthritis Pain in Dogs using Force Plate Gait Analysis

Introduction: A randomized, double-blinded, noninferiority study was conducted to evaluate the efficacy of bedinvetmab (Librela) compared with a nonsteroidal anti-inflammatory drug using objective force plate gait analysis (FPGA).

Materials and Methods: Thirty-two eligible dogs (>20 kg, ≥ 1-year-old) with osteoarthritis exclusively at hips and/or stifles were randomized 1:1 to the licensed dose of monthly subcutaneous (SC) bedinvetmab (plus daily oral placebo) or daily oral grapiprant (plus monthly SC saline) beginning on day 0 (D0). FPGA and the Liverpool Osteoarthritis in Dogs Index (LOAD) were collected at D0 before treatment and every 14 days for 2 months. Based on published FPGA parameters, success-failure rates were calculated for each group. A noninferiority margin of 4.2% at D42 was defined a priori.

Results: D42 FPGA treatment success rate was 62.5% (CI: 38.6–81.5) in both groups; thus, noninferiority criteria were met. Mean (±SD) D42 PVF increase was 3.12 (3.84%) bodyweight and 3.26 (4.59%) bodyweight for bedinvetmab and grapiprant, respectively; both groups showed significant (p ≤ 0.05) improvement compared with D0. Success rates at D14 and D28 were 69 and 69% for bedinvetmab, and 67 and 50% for grapiprant, respectively. D42 LOAD showed significant improvement compared with D0 for both groups; treatment success rates were 75 and 62.5% for bedinvetmab and grapiprant, respectively. Adverse events were in line with respective label expectations. Adverse events occurred in 9/16 and 8/16 dogs in the grapiprant and bedinvetmab groups, respectively.

Discussion/Conclusion: These data demonstrate the noninferiority of bedinvetmab to grapiprant based on FPGA-measured PVF (D14, D28, and D42) and bedinvetmab showed good tolerability.

Acknowledgment

This study was funded by Zoetis Inc. L.B.D.X. and I.J.F. are paid consultants for Zoetis.

 

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Publication History

Article published online:
15 July 2025