Apoquel^® (oclacitinib tablet) Efficacy

• Dogs were client-owned and of any pure or mixed breed in apparent good health at the time of the Day 0 physical examination
• The owner must have given written informed consent for each dog to participate in the study
• Dogs may have been intact or neutered
• Dogs were 12 months of age or older and weighed between 3 kg and 80 kg at the time of the Day 0 visit
• Dogs were eligible for enrollment on Day 0 based on a client complaint of pruritus assessed by the owner as “moderate itching,” “severe itching” or “extremely severe itching” using the categorical scale on the Current Description of Pruritus form
• Investigators attributed the dog’s pruritic condition to a known or presumptive diagnosis of allergic dermatitis, attributable to at least 1 of the following:
  • Food allergy
  • Contact allergy
  • Flea allergy
  • Atopic dermatitis
  • Unspecified allergic dermatitis (unless prohibited in exclusion criteria)
• If the dog had an incidental health condition that required treatment, the treatment had remained the same for at least 6 weeks, and no change in treatment was anticipated for the duration of the study
• The dog was flea-free at the time of the Day 0 visit or, if visual inspection showed evidence of fleas, appropriate flea control measures were implemented on Day 0
• Dogs previously diagnosed (prior to Day 0) as food allergic who were receiving a hypoallergenic diet had been on the diet for at least 6 weeks prior to Day 0 and remained on the same diet during the study
• If the dog had received intradermal allergy testing, the test must have been conducted a minimum of 8 weeks prior to study start
• If desensitization immunotherapy had been initiated, the dog must have been on immunotherapy for 6 months or more. If desensitization immunotherapy had been discontinued, it must have been discontinued for at least 8 weeks prior to enrollment
• If the dog was receiving conditionally allowed concomitant medications, the dose and dose rate were not anticipated to change during the course of the study

• A masked, multisite, well-controlled, 112-day study of 299 dogs conducted by 18 veterinary dermatologists in the United States evaluated the effectiveness (Owner Pruritus VAS and CADESI-02 scores) and safety of Apoquel dosed at 0.4-0.6 mg/kg twice daily (BID) for 14 days followed by once daily (SID) dosing for the control of atopic dermatitis
• Determination of effectiveness was based on improvement from Day 0 to Day 28 (±2)

CADESI-02=Canine Atopic Dermatitis Extent and Severity Index, Version 2; Pruritus VAS=Visual Analog Scale (0-100 mm).

• Dogs were client-owned and of any breed or mixed breed in apparent good health at the time of the Day 0 physical examination
• The owner gave written informed consent for each dog to participate in the study
• Dogs were intact or neutered
• Dogs were 12 months of age or older at the time of the Day 0 visit
• Dogs weighed between 3 kg and 80 kg at the time of the Day 0 visit
• Dogs were eligible for enrollment on Day 0 based on a client complaint of pruritus assessed by the owner as “moderate itching,” “severe itching” or “extremely severe itching” using the categorical scale on the Current Description of Pruritus form
• Dogs had a documented history of chronic, nonseasonal atopic dermatitis (disease present or recurrent for at least 1 year). Establishment of the diagnosis was made based on compatible history, clinical signs and exclusion of other diagnoses
• All dogs underwent a diagnostic regimen, as determined by the investigator, sufficient to eliminate from consideration typical rule-outs for atopic dermatitis (ie, food allergy, flea allergy dermatitis, bacterial or fungal dermatitis otitis, internal and external parasitism, metabolic disease). Intradermal testing or serologic testing for immunoglobulin E was desirable, but was not required to have established the diagnosis
• Compatible history to confirm the diagnosis of atopic dermatitis was based on Prélaud’s modification of Willemse’s criteria, which included the presence of at least 3 of the following major criteria:

• First clinical signs apparent between 6 months and 3 years of age
• Corticosteroid-responsive pruritus
• Bilateral erythematous interdigital pododermatitis
• Erythema of the concave aspect of the pinnae
• Cheilitis and/or facial inflammation

• Dogs had to have a minimum CADESI-02 score of 25 at the time of the Day 0 visit to be enrolled in the study­­­­
• If the dog had an incidental health condition on Day 0 that required treatment, the treatment remained the same for at least 6 weeks, and no change in treatment was anticipated for the duration of the study
• The dog was flea-free at the time of the Day 0 visit, and the owner used flea control/prevention throughout the study period. If necessary, the dog’s home environment was treated with a veterinary-approved flea-elimination program. Dogs with a prior diagnosis of flea allergy dermatitis were included in the study provided they had concurrent atopic dermatitis and were using flea control/prevention. If visual inspection showed evidence of fleas, the dog was not eligible for inclusion in the study at that time. Appropriate flea-control measures could then have been implemented, and the dog could have been reconsidered for enrollment at a later date
• Dogs previously diagnosed (prior to Day 0) as food allergic (with concurrent atopic dermatitis) who were being fed a hypoallergenic diet had been on the diet for at least 6 weeks prior to Day 0 and had to have remained on the same diet during the study. The food allergy had to be controlled by the hypoallergenic diet. All food allergen sources identified during dietary restriction testing had to have been excluded from the diet. The dog had to have been maintained on the same hypoallergenic diet through the course of the study
• All dogs (regardless of food allergy status) remained on the same diet for the duration of the study
• If the dog had received intradermal testing, the testing had to have occurred a minimum of 8 weeks prior to study start
• If desensitization immunotherapy had been initiated, the dog had to have been on immunotherapy for 12 months or more
• If desensitization immunotherapy had been discontinued, it had to have been discontinued for at least 8 weeks prior to enrollment
• If the dog received conditionally allowed concomitant medications, the dose and dose rate were not anticipated to change during the course of the study
• If the dog was receiving any concomitant medications, the owner/investigator complied with all withdrawal times, minimal usage and frequency of usage

• This study was conducted by 12 general practitioners in Australia with an interest in dermatology as a randomized, controlled, multicenter, blinded 28-day clinical trial of 123 dogs. Apoquel was administered at a dosage of 0.4-0.6 mg/kg twice daily for 14 days followed by 0.4-0.6 mg/kg once daily up to Day 28 (±2) and was compared to a control group administered prednisolone at a dose rate of 0.5-1.0 mg/kg once daily up to Day 6 (±1) followed by 0.5-1.0 mg/kg every second day up to Day 28 (±2)
• The primary efficacy variable was the percentage reduction from baseline (pretreatment) for owner-assessed pruritus at Day 14 of the study. Pruritus was assessed by owners on a 100 mm enhanced visual analog scale (VAS). The difference between VAS scores on Day 0 (pretreatment) and Day 14 was used to calculate the least squares mean percentage reduction from baseline for each treatment group, and contrasts were used to compare treatments

• Dogs were client-owned, of any pure or mixed breed, in apparent good health at the time of the Day 0 physical examination
• The owner must have given written informed consent for each dog to participate in the study
• Dogs may have been intact or neutered
• Dogs were 12 months of age or older and weighed between 3 kg and 80 kg at the time of the Day 0 visit
• Dogs were eligible for enrollment on Day 0 based on a client complaint of pruritus assessed by the owner as “moderate itching,” “severe itching” or “extremely severe itching” using the categorical scale on the Current Description of Pruritis form
• Investigators attributed the dog’s pruritic condition to a known or presumptive diagnosis of allergic dermatitis, attributable to at least 1 of the following:

• Food allergy
• Contact allergy
• Flea allergy
• Atopic dermatitis
• Unspecified allergic dermatitis (unless prohibited in exclusion criteria)

• If the dog had an incidental health condition that required treatment, the treatment had remained the same for at least 6 weeks, and no change in treatment was anticipated for the duration of the study
• The dog was flea-free at the time of the Day 0 visit, or if visual inspection showed evidence of fleas, appropriate flea-control measures were implemented on Day 0
• Dogs previously diagnosed (prior to Day 0) as food allergic who were receiving a hypoallergenic diet had been on the diet for at least 6 weeks prior to Day 0 and remained on the same diet during the study
• If the dog had received intradermal allergy testing, the test must have been conducted a minimum of 8 weeks prior to study start
• If desensitization immunotherapy had been initiated, the dog must have been on immunotherapy for 6 months or more. If desensitization immunotherapy had been discontinued, it must have been discontinued for at least 8 weeks prior to enrollment
• If the dog was receiving conditionally allowed concomitant medications, the dose and dose rate were not anticipated to change during the course of the study

• This study by 12 general practitioners in Australia with an interest in dermatology was conducted as a randomized, controlled, multicenter, blinded 28-day clinical trial of 123 dogs. Apoquel was administered at a dosage of 0.4-0.6 mg/kg twice daily for 14 days followed by 0.4-0.6 mg/kg once daily up to Day 28 (±2) and was compared to a control group administered prednisolone at a dose rate of 0.5-1.0 mg/kg once daily up to Day 6 (±1) followed by 0.5-1.0 mg/kg every second day up to Day 28 (±2)

• The primary efficacy variable was the percentage reduction from baseline (pretreatment) for owner-assessed pruritus at Day 14 of the study. Pruritus was assessed by owners on a 100 mm enhanced visual analog scale (VAS). The difference between VAS scores on Day 0 (pretreatment) and Day 14 was used to calculate the least squares mean percentage reduction from baseline for each treatment group, and contrasts were used to compare treatments