John F Innes, B Duncan X Lascelles, Daniel Bell, Robert Tulloch, Alex McVey, Chad Northcott, Mahala Welbourn, Kate Higgins, Veronika Horakova, Thomas W Maddox
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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 (<i>p</i> < 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 (<i>p</i> < 0.001). The bedinvetmab group reported four (AEs), whilst the meloxicam group reported 17, with nine of those being gastrointestinal system disorders. 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引用次数: 0
摘要
Bedinvetmab (Librela®)是一种全犬抗神经生长因子单克隆抗体,在一项随机、开放标签、多中心、平行组研究中,研究人员将其与非甾体抗炎药(NSAID)美洛西康进行比较,以治疗犬骨关节炎相关疼痛。受试者从一般诊所招募,作为客户拥有的患有阑尾骨关节炎的狗。狗按1:1的比例随机分组,每日口服美洛昔康或贝地韦单抗,每月皮下注射一次。疗效的主要终点是犬骨科指数(COI)评分较基线的变化。采用线性混合效应模型对每个方案和治疗意向进行统计分析。我们假设bedinvetmab与美洛昔康相比具有更好的疗效和安全性;计算美洛昔康相对于贝帝韦单抗的所需伤害数(NNH)。在190只筛选的狗中,101只被随机分配(bedinvetmab 52;meloxicam 49)。总的来说,与美洛昔康组(n = 33)相比,两个治疗组的COI评分相对于基线有显著降低(p p n = 44)。这是第一个比较bedinvetmab与非甾体抗炎药治疗犬骨关节炎相关疼痛的研究。结果表明,两种产品在治疗OA疼痛方面同样有效,随着时间的推移,两种治疗方法的疗效都在提高。Bedinvetmab与较少的ae相关。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狗选择镇痛药。
A randomised, parallel-group clinical trial comparing bedinvetmab to meloxicam for the management of canine osteoarthritis.
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 (p < 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 (p < 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 (n = 44) compared to those in the meloxicam group (n = 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.
期刊介绍:
Frontiers in Veterinary Science is a global, peer-reviewed, Open Access journal that bridges animal and human health, brings a comparative approach to medical and surgical challenges, and advances innovative biotechnology and therapy.
Veterinary research today is interdisciplinary, collaborative, and socially relevant, transforming how we understand and investigate animal health and disease. Fundamental research in emerging infectious diseases, predictive genomics, stem cell therapy, and translational modelling is grounded within the integrative social context of public and environmental health, wildlife conservation, novel biomarkers, societal well-being, and cutting-edge clinical practice and specialization. Frontiers in Veterinary Science brings a 21st-century approach—networked, collaborative, and Open Access—to communicate this progress and innovation to both the specialist and to the wider audience of readers in the field.
Frontiers in Veterinary Science publishes articles on outstanding discoveries across a wide spectrum of translational, foundational, and clinical research. The journal''s mission is to bring all relevant veterinary sciences together on a single platform with the goal of improving animal and human health.