title: Confirmatory field study for the evaluation of ciclosporin at a target dose of 7.0 mg/kg (3.2 mg/lb) in the control of feline hypersensitivity dermatitis.
abstract: Objectives This study was designed to confirm the efficacy and tolerability of a daily dose of 7.0 mg/kg (3.2 mg/lb) ciclosporin (CsA) in the treatment of feline hypersensitivity dermatitis (HD), as this includes some of the most frequently suspected skin diseases in cats and recent publications have reported the successful use of CsA in the treatment of feline HD. Methods In total, 217 cats with feline HD were treated daily for 42 days with a target dose of 7 mg/kg CsA (n = 144) or a placebo control (n = 73) administered either in the food or directly in the mouth following feeding. Clinical and dermatological evaluations were conducted on days 0, 21 and 42, or study exit. Safety was evaluated through physical examinations, clinical pathology and the monitoring of adverse events (AEs). Results Administration of CsA at 7.0 mg/kg produced a significant improvement in the total lesion score ( P <0.0001). The average reduction from visit 1 to visit 3 was 65.1% in the CsA group (9.2% for the placebo). In addition, owners assessed 78.3% of the cases in the CsA group as a success. Statistically significant recoveries were also seen in extent of lesions, investigator assessment of overall improvement, and mean improvement in both the investigators' and owners' assessment of pruritus. Mild gastrointestinal disorders were the most common AEs but did not require cessation of therapy. Conclusions and relevance Results confirm that 7.0 mg/kg CsA dosed daily in food or orally for up to 6 weeks is effective and well tolerated by cats with feline HD.
authors.affiliation: 1 Novartis Animal Health US, Greensboro, NC, USA.
authors.forename: Elizabeth S
authors.initials: ES
authors.lastname: Roberts
authors.affiliation: 2 Novartis Animal Health, Basel, Switzerland.
authors.forename: Cindy
authors.initials: C
authors.lastname: Speranza
authors.affiliation: 3 Animal Dermatology Center of Chicago, Chicago, IL, USA.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Friberg
authors.affiliation: 4 Animal Dermatology Clinic, San Diego, CA, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Griffin
authors.affiliation: 2 Novartis Animal Health, Basel, Switzerland.
authors.forename: Jean
authors.initials: J
authors.lastname: Steffan
authors.affiliation: 1 Novartis Animal Health US, Greensboro, NC, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Roycroft
authors.affiliation: 1 Novartis Animal Health US, Greensboro, NC, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: King
mesh_terms: D000818:Animals; D002170:Canada; D002371:Cat Diseases / Q000188:drug therapy* / Q000473:pathology; D002415:Cats; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000188:drug therapy / Q000662:veterinary*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D011537:Pruritus / Q000188:drug therapy / Q000662:veterinary; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine