A noninferiority trial evaluating the efficacy of bedinvetmab compared to grapiprant for osteoarthritis-pain in dogs using force plate gait analysis

Abstract

A randomized, double-blind, non-inferiority study was conducted to evaluate efficacy of bedinvetmab compared to grapiprant using objective force plate gait analysis (FPGA). Thirty-two eligible dogs (> 20 kg, ≥ 1 year-old) with osteoarthritis (OA) 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 client-reported outcome measures (CROMs) were collected at screening, D0, and every 14 days for 2 months. Based on published FPGA parameters, success-failure rates were calculated for each group. A non-inferiority margin of 21.25% at D42 was defined a priori. FPGA treatment success rate at D42 was 68.8% for bedinvetmab and 56.3% for grapiprant, with the difference being 12.5% (90% confidence interval = -37.5, 18.8). Given that the upper bound of this interval (18.8%) was less than the pre-specified non-inferiority margin of 21.25%, bedinvetmab was concluded to be non-inferior to grapiprant. Overall, pain and associated clinical signs were significantly improved after both treatments based on CROMs. Adverse events were in line with respective label expectations. These data support both bedinvetmab and grapiprant are appropriate first-line treatments for OA pain in dogs.