Veterinary dermatology · 2026
Efficacy and Safety of Allogeneic Mesenchymal Stromal Cells Versus Lokivetmab in Mild-To-Moderate Canine Atopic Dermatitis: A Single-Blind Randomised Study.
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Pasikowska Marta, Ciszewska-Ceran Jagoda, Cekiera Agnieszka, Gocek Elżbieta, Grzesiak Jakub, Reniewicz Patryk, Popiel Jarosław, Szczepanik Marcin, Wilkołek Piotr
Аннотация
BACKGROUND: 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.
OBJECTIVE: To evaluate the efficacy and safety of an investigational allogeneic adipose-derived MSC product (PK/CM-1) in dogs with cAD.
MATERIALS AND METHODS: 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.
RESULTS: 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.
CONCLUSIONS AND CLINICAL RELEVANCE: 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.
OBJECTIVE: To evaluate the efficacy and safety of an investigational allogeneic adipose-derived MSC product (PK/CM-1) in dogs with cAD.
MATERIALS AND METHODS: 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.
RESULTS: 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.
CONCLUSIONS AND CLINICAL RELEVANCE: 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.