Clinical trial evaluating the efficacy and safety of cyclosporine in dogs with atopic dermatitis.
OBJECTIVE
To determine efficacy and safety of cyclosporine in the treatment of atopic dermatitis among dogs in North America.


METHODS
Randomized controlled (phase 1) and open-label (phase 2) trials.


METHODS
268 dogs with atopic dermatitis.


METHODS
In phase 1, dogs were randomly assigned to be treated with cyclosporine (5 mg/kg [2.3 mg/Ib], PO, q 24 h) or a placebo. In phase 2, all dogs were treated with cyclosporine for 16 weeks. Frequency of cyclosporine administration was decreased if dogs improved clinically.


RESULTS
At the end of phase 1, canine atopic dermatitis extent and severity index (CADESI) scores for dogs treated with cyclosporine were significantly lower than scores for control dogs. Percentage of dogs with severe pruritus decreased from 67% to 16% for the cyclosporine group but from 66% to only 61% for the control group. During phase 2, cyclosporine dosage was decreased to every-other-day administration in 39% of the dogs after 4 weeks. After 12 weeks, 22% of the dogs were treated twice weekly and 36% were treated every other day. After 16 weeks, CADESI score had decreased > 50% in 68% of the dogs and 47% of dogs had no or mild pruritus. The most frequent adverse reactions were gastrointestinal tract signs.


CONCLUSIONS
Results suggest that cyclosporine is efficacious for the treatment of atopic dermatitis in dogs and that frequency of cyclosporine administration can be reduced following an initial induction period. The drug was well tolerated.
Steffan
Jean
J
Novartis Animal Health, CH4002 Basel, Switzerland.
Parks
Craig
C
Seewald
Wolfgang
W
D000284:Administration, Oral; D000818:Animals; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000188:drug therapy / Q000473:pathology / Q000662:veterinary*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004283:Dog Diseases / Q000188:drug therapy* / Q000473:pathology; D004285:Dogs; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule / Q000662:veterinary; D005260:Female; D008297:Male; D011537:Pruritus / Q000188:drug therapy / Q000473:pathology / Q000662:veterinary; D012449:Safety; D016896:Treatment Outcome
D003879:Dermatologic Agents; D016572:Cyclosporine