title: Evaluation of a human generic formulation of ciclosporin in the treatment of canine atopic dermatitis with in vitro assessment of the functional capacity of phagocytic cells.
abstract: To compare the efficacy, tolerability and safety of a generic formulation of ciclosporin for human beings with prednisone in the treatment of canine atopic dermatitis), human generic ciclosporin A (hgCsA) (5 mg/kg daily) and prednisone (1 mg/kg daily for seven days, followed by 1 mg/kg every second day) were administered to 13 and seven dogs with atopic dermatitis, respectively, for 42 days. Skin changes were assessed using a modified canine atopic dermatitis extent and severity index (mCADESI-01) and a pruritus intensity scale system. The in vitro functional capacity of phagocytic cells was assessed using the tetrazolium reductase activity and zymosan-stimulated tetrazolium reductase activity tests, as well as measurements of the percentage phagocytic activity and the ingestion capacity of phagocytic cells. Haematological and biochemical parameters were also monitored. There was a greater than or equal to 50 per cent reduction from the baseline in mCADESI-01 scores in 84.6 and 100 per cent of dogs, and a greater than or equal to 50 per cent reduction from the baseline in pruritus scores in 76.9 and 85.7 per cent of dogs, treated with hgCsA and prednisone, respectively. No important adverse physical, haematological or biochemical effects occurred with either drug and no statistically significant changes were detected in any of the four tests assessing the functional activity of phagocytes. The generic formulation of ciclosporin was effective in reducing the severity of physical signs of canine atopic dermatitis and was well tolerated.
authors.affiliation: University of Veterinary Medicine and Pharmacy in Košice, 041 81 Košice, Slovak Republic. mkovalikos@yahoo.com
authors.forename: M
authors.initials: M
authors.lastname: Kovalik
authors.forename: I
authors.initials: I
authors.lastname: Taszkun
authors.forename: Z
authors.initials: Z
authors.lastname: Pomorski
authors.forename: M
authors.initials: M
authors.lastname: Kozak
authors.forename: D
authors.initials: D
authors.lastname: Pomorska
authors.forename: M
authors.initials: M
authors.lastname: Szczepanik
authors.forename: P
authors.initials: P
authors.lastname: Wilkolek
authors.forename: L
authors.initials: L
authors.lastname: Palenik
authors.forename: D J
authors.initials: DJ
authors.lastname: Shaw
authors.forename: A H M
authors.initials: AH
authors.lastname: van den Broek
authors.forename: K L
authors.initials: KL
authors.lastname: Thoday
mesh_terms: D000818:Animals; D016572:Cyclosporine / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000188:drug therapy / Q000473:pathology / Q000662:veterinary*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004283:Dog Diseases / Q000188:drug therapy* / Q000473:pathology; D004285:Dogs; D005260:Female; D006801:Humans; D008297:Male; D010586:Phagocytes / Q000187:drug effects / Q000502:physiology*; D010865:Pilot Projects; D011241:Prednisone / Q000627:therapeutic use; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D016572:Cyclosporine; D011241:Prednisone