同种异体间充质干细胞与Lokivetmab治疗轻至中度犬特应性皮炎的疗效和安全性：一项单盲随机研究。 机翻

中文关键词（术语机标，非人工翻译）：异位性皮炎 · 皮肤病 · 弗雷格鲁单抗

摘要

<h4>Background</h4>Canine atopic dermatitis (cAD) is a chronic allergic inflammatory skin disease that requires multimodal management. Allogeneic mesenchymal stromal cells (MSCs) have emerged as a potential therapeutic option.<h4>Objective</h4>To evaluate the efficacy and safety of an investigational allogeneic adipose-derived MSC product (PK/CM-1) in dogs with cAD.<h4>Materials and methods</h4>Dogs with mild-to-moderate cAD were enrolled in a single-blind, randomised study and allocated in a 2:1 ratio either to an experimental group (receiving a single intravenous dose of PK/CM-1) or a control group (receiving three monthly subcutaneous doses of lokivetmab). Clinical outcomes were assessed using the Canine Atopic Dermatitis Extent and Severity Index, 4th iteration (CADESI-04) and pruritus Visual Analog Scale (PVAS) scores on Day (D)28 (primary end-point) and D7, D56 and D84. Safety assessments included haematological and biochemical analyses on D84, along with monitoring for adverse events.<h4>Results</h4>Thirty-two dogs were included. By D28, both CADESI-04 and PVAS scores had significantly decreased from baseline in both groups. No significant differences between groups were observed on D28 (p = 0.696 and p = 0.088, respectively). Clinical improvement was sustained up to D84. In the experimental group, CADESI-04 and PVAS scores were lower on D84 than on D28 (p = 0.0074 and p = 0.0015, respectively). Two adverse events (one severe and one mild) occurred during PK/CM-1 administration. No clinically significant haematological or biochemical abnormalities were observed.<h4>Conclusions and clinical relevance</h4>PK/CM-1 demonstrated comparable efficacy and safety to those of lokivetmab over a 3 month period. Careful monitoring is recommended during intravenous administration of PK/CM-1.

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