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一项比较贝迪维单抗与美洛昔康治疗犬骨关节炎的随机平行组临床试验。

A randomised, parallel-group clinical trial comparing bedinvetmab to meloxicam for the management of canine osteoarthritis.

作者信息

Innes John F, Lascelles B Duncan X, Bell Daniel, Tulloch Robert, McVey Alex, Northcott Chad, Welbourn Mahala, Higgins Kate, Horakova Veronika, Maddox Thomas W

机构信息

Movement Referrals: Independent Veterinary Specialists, Runcorn, United Kingdom.

Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Leahurst Campus, Neston, United Kingdom.

出版信息

Front Vet Sci. 2025 Mar 24;12:1502218. doi: 10.3389/fvets.2025.1502218. eCollection 2025.

Abstract

Bedinvetmab (Librela), a fully canine anti-nerve growth factor monoclonal antibody, was compared to the non-steroidal anti-inflammatory drug (NSAID) meloxicam in dogs for the management of osteoarthritis-related pain in a randomised, open-label, multicentre, parallel-group study. Subjects were recruited from general practices as client-owned dogs with appendicular osteoarthritis. Dogs were block randomised 1:1 to either daily oral meloxicam or bedinvetmab, administered subcutaneously once a month. The primary endpoint for efficacy was the change from baseline in the Canine Orthopaedic Index (COI) score. Linear mixed-effects models were used for statistical analysis conducted on a per-protocol and intent-to-treat basis. We hypothesised that bedinvetmab would demonstrate superior efficacy and safety compared to meloxicam; the number needed to harm (NNH) for meloxicam, relative to bedinvetmab, was calculated. Of the 190 screened dogs, 101 were randomised (bedinvetmab 52; meloxicam 49). Overall, both treatment groups showed a significant reduction in COI scores relative to baseline ( < 0.001). The bedinvetmab group experienced a larger mean reduction in COI scores, but this was not statistically significant. A significant effect of the visit was observed, with later visits showing a significantly greater reduction in COI compared to Visit 2 ( < 0.001). The bedinvetmab group reported four (AEs), whilst the meloxicam group reported 17, with nine of those being gastrointestinal system disorders. Additionally, more dogs in the bedinvetmab group completed the study ( = 44) compared to those in the meloxicam group ( = 33). This is the first study to compare bedinvetmab to an NSAID for the management of osteoarthritis-related pain in dogs. The results suggest that both products are equally effective in managing OA pain, with efficacy improving over time for both treatments. Bedinvetmab was associated with fewer AEs. These data will aid clinicians and pet owners in choosing analgesic options for dogs with osteoarthritis.

摘要

在一项随机、开放标签、多中心、平行组研究中,将完全犬用抗神经生长因子单克隆抗体贝迪维单抗(利伯雷拉)与非甾体抗炎药美洛昔康用于犬类骨关节炎相关疼痛的治疗进行比较。研究对象从普通诊所招募,为患有附肢性骨关节炎的宠物犬。犬只按1:1进行区组随机分组,分别每日口服美洛昔康或每月皮下注射一次贝迪维单抗。疗效的主要终点是犬类骨科指数(COI)评分相对于基线的变化。采用线性混合效应模型在符合方案集和意向性分析基础上进行统计分析。我们假设贝迪维单抗与美洛昔康相比将显示出更好的疗效和安全性;计算了美洛昔康相对于贝迪维单抗的伤害所需人数(NNH)。在190只筛查犬中,101只被随机分组(贝迪维单抗组52只;美洛昔康组49只)。总体而言,两个治疗组的COI评分相对于基线均显著降低(<0.001)。贝迪维单抗组COI评分的平均降低幅度更大,但无统计学意义。观察到访视有显著影响,与第2次访视相比,后期访视显示COI评分降低幅度显著更大(<0.001)。贝迪维单抗组报告了4例不良事件(AE),而美洛昔康组报告了17例,其中9例为胃肠道系统疾病。此外,与美洛昔康组(=33)相比,贝迪维单抗组完成研究的犬只更多(=44)。这是第一项比较贝迪维单抗与非甾体抗炎药用于犬类骨关节炎相关疼痛治疗的研究。结果表明,两种产品在管理骨关节炎疼痛方面同样有效,且两种治疗的疗效均随时间提高。贝迪维单抗的不良事件较少。这些数据将有助于临床医生和宠物主人为患有骨关节炎的犬只选择镇痛方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e14d/11974340/c7d0750aacf5/fvets-12-1502218-g001.jpg

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