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福来奴单抗,一种猫源抗神经生长因子单克隆抗体,用于治疗猫骨关节炎疼痛。

Frunevetmab, a felinized anti-nerve growth factor monoclonal antibody, for the treatment of pain from osteoarthritis in cats.

机构信息

Translational Research in Pain (TRiP) Program, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA.

Behavioral Medicine, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA.

出版信息

J Vet Intern Med. 2021 Nov;35(6):2752-2762. doi: 10.1111/jvim.16291. Epub 2021 Nov 1.

Abstract

BACKGROUND

Frunevetmab, a felinized antinerve growth factor monoclonal antibody, effectively decreases osteoarthritis (OA) pain in cats.

OBJECTIVE

To evaluate the efficacy of frunevetmab given at monthly intervals in a randomized, placebo-controlled, parallel-group, double-blind superiority study.

ANIMALS

Two hundred seventy-five client-owned cats with naturally-occurring OA pain and associated mobility impairment and disability.

METHODS

Randomized, placebo-controlled, parallel-group, double-blind, superiority study. Following screening, cats received frunevetmab (nominal dose of 1.0 mg/kg, SC [effective dose range of 1.0-2.8 mg/kg]) or placebo on days 0, 28, and 56. Outcome measures were owner questionnaires and veterinary physical and orthopedic evaluations at days 28, 56, and 84. Success/failure rates (and numbers needed treat, NNT) and change in scores (and standardized effect size, ES) were analyzed.

RESULTS

Frunevetmab (182) and placebo (93) treated cats were enrolled and received at least 1 treatment. Significant improvement with frunevetmab over placebo occurred at days 28 and 56 for the client specific outcome measures (CSOM) questionnaire (success rates and total scores [NNT of 9 and ES of 0.3 at day 56]); at days 28 and 56 for owner-assessed global treatment response; and at days 56 and 84 for veterinarian-assessed joint pain (ES of 0.18 at day 56). Adverse events did not differ between groups, except skin disorders which collectively occurred significantly more frequently in frunevetmab treated (32/182 cats) vs placebo (8/93 cats).

CONCLUSIONS AND CLINICAL IMPORTANCE

Frunevetmab has the potential to address a critical gap in the treatment of pain because of osteoarthritis in cats.

摘要

背景

Frunevetmab 是一种猫源抗神经生长因子单克隆抗体,可有效减轻猫的骨关节炎(OA)疼痛。

目的

评估 Frunevetmab 每月给药在一项随机、安慰剂对照、平行组、双盲优效研究中的疗效。

动物

275 只患有自发性 OA 疼痛且伴有运动功能障碍和残疾的患宠猫。

方法

随机、安慰剂对照、平行组、双盲、优效性研究。筛选后,猫在第 0、28 和 56 天接受 Frunevetmab(名义剂量为 1.0mg/kg,SC[有效剂量范围为 1.0-2.8mg/kg])或安慰剂。主要结局指标为第 28、56 和 84 天的主人问卷调查和兽医的体格检查和骨科检查。成功率/失败率(和需要治疗的数量,NNT)和评分变化(和标准化效应量,ES)进行分析。

结果

182 只 Frunevetmab 治疗猫和 93 只安慰剂治疗猫入组并接受至少 1 次治疗。Frunevetmab 与安慰剂相比,在第 28 和 56 天的客户特定结局测量(CSOM)问卷(成功率和总分[第 56 天的 NNT 为 9 和 ES 为 0.3]);在第 28 和 56 天的主人评估整体治疗反应;以及在第 56 和 84 天兽医评估关节疼痛(第 56 天的 ES 为 0.18)有显著改善。两组之间的不良事件没有差异,除了皮肤疾病,Frunevetmab 治疗组(182 只猫中有 32 只)比安慰剂组(93 只猫中有 8 只)更常见。

结论和临床意义

Frunevetmab 有潜力解决猫骨关节炎疼痛治疗的一个关键空白。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dfad/8692178/6d0faee7743a/JVIM-35-2752-g003.jpg

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