STUDY DESIGN³

• A non-inferiority trial of 123 dogs intended to demonstrate the efficacy and safety of APOQUEL for the control of pruritus and clinical signs associated with allergic dermatitis in client-owned dogs. APOQUEL was dosed at 0.4-0.6 mg/kg twice daily (BID) for up to Day 14 (±2), followed by 0.4-0.6 mg/kg once daily (SID) up to Day 28 (±2)
• Comparison was with a positive control drug, prednisolone, dosed at 0.5-1.0 mg/kg SID for up to Day 6 (±1), followed by 0.5-1.0 mg/kg every other day (EOD)

INCLUSION CRITERIA⁴

• Dogs were client-owned dogs, of any pure or mixed breed, in apparent good health at the time of the Day 0 physical examination
• The Owner (or authorized agent) 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 ≥3 kg and ≤80 kg, at the time of the Day 0 visit
• Dogs were eligible for enrollment based on a client complaint of pruritus assessed by the Owner as “moderate itching,” “severe itching” or “extremely severe itching” using a categorical scale
• Investigator attributed the dog’s pruritic condition to a known or presumptive diagnosis of allergic dermatitis, attributable to at least one 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 this 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 that 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

STUDY DESIGN^5,6

• A masked study of 226 dogs to demonstrate the safety and efficacy of APOQUEL compared with the current standard of treatment, Atopica® (cyclosporine capsules, USP), for the control of atopic dermatitis in client-owned dogs
• The study measured percentage reduction from baseline for:
  (i) Owner-assessed pruritus VAS, and
  (ii) Investigator-assessed CADESI-02, each incorporating a non-inferiority test at Day 28 (±2)
• Dosing throughout the study was per label:
  • APOQUEL was dosed at the label dose of 0.4-0.6 mg/kg twice daily (BID) for 14 days, then once daily (SID) until Day 84
  • Atopica was dosed at the label dose of 3.2-6.6 mg/kg SID throughout the study
    
    

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

INCLUSION CRITERIA⁶

• Dogs 12 months of age or older, weighing between 3.0 and 80.0 kg
• History compatible with a diagnosis of chronic, non-seasonal atopic dermatitis
• Presence of at least 3 of the following 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
  • Chelitis and/or facial inflammation
• Current level of pruritus assessed by the owner of at least “moderate itching”
• Minimum baseline CADESI-02 score of 25

STUDY DESIGN⁸

• A masked, multisite, well-controlled, 112-day study of 299 dogs conducted by 18 veterinary dermatologists in the US evaluated the effectiveness (Owner VAS and Canine Atopic Dermatitis Extent and Severity Index [CADESI]-02 scores) and safety of APOQUEL, dosed at 0.4 to 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)

INCLUSION CRITERIA¹

• 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 (or authorized agent/designee) gave written informed consent for each dog to participate in the study
• Dogs were of both sexes and could be intact or neutered
• Dogs were 6 months of age or older at the time of the Day 0 visit
• Dogs weighed ≥3 kg and ≤80 kg at the time of the Day 0 visit
• Dogs were assessed by the Owner as having “moderate itching” (regular episodes of itching when the dog is awake; itching might occur at night and wake the dog; no itching when eating, playing, or exercising or when being distracted), or another more severe category using the categorical scale on the Current Description of Pruritus form
• The Investigator attributed the dog’s pruritic condition to a known or presumptive diagnosis of allergic dermatitis. The dog’s allergic dermatitis was attributable to at least one of the following: food allergy, contact allergy, flea allergy, atopic dermatitis, sarcoptic mange, unspecified allergic dermatitis (unless prohibited in exclusion criteria)
• For dogs with an incidental health condition that required treatment, the treatment remained the same for at least the 6 weeks prior to Day 0 and no change in treatment occurred during the study except as noted in the protocol deviations 
• If visual inspection showed evidence of fleas or if sarcoptic mange was identified, appropriate flea or mange control measures were implemented. Treatment to control fleas or sarcoptic mange could be implemented at Day 0 whether or not fleas or mange mites were observed on the dog
• Dogs previously diagnosed (prior to Day 0) as food allergic that were receiving hypoallergenic diet were on the diet for at least 6 weeks prior to Day 0 and remained on the same diet during the study
• If dogs received intradermal testing, the test was conducted a minimum of 8 weeks prior to study start
• If desensitization immunotherapy was initiated, dogs were on immunotherapy for 6 months or more
• If desensitization immunotherapy was discontinued, it was discontinued at least 8 weeks prior to enrollment
• If dogs were receiving conditionally allowed concomitant medications, the dose and dose rate did not change during the course of the study except as noted in the protocol deviations
• If dogs were receiving any concomitant medications, the Owner/ Investigator complied with all withdrawal times, minimal usage and frequency of usage except as noted in the protocol deviations
  • Allowed medicated or therapeutic shampoos included moisturizing, emollient, keratolytic, antiseborrheic, antimycotic, or antiseptic shampoos and rinses applied topically. Specifically prohibited were any antipruritic or anti-inflammatory shampoos containing steroids and/or antihistamines

STUDY DESIGN⁸

• A masked, multisite, well-controlled, 112-day study of 299 dogs conducted by 18 veterinary dermatologists in the United States evaluated the effectiveness (Owner VAS and CADESI-02 scores) and safety of APOQUEL, dosed at 0.4 to 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)

INCLUSION CRITERIA⁷

• 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 (or authorized agent/designee) 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 ≥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/dermatitis,” “severe itching/dermatitis” or “extremely severe itching/dermatitis” using a categorical scale (Current Description of Pruritus form)
• Dogs had a documented history of chronic, non-seasonal atopic dermatitis (disease present or recurrent for at least 1 year). Establishment of the diagnosis was made based upon 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 (IDT) 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
  • Chelitis and/or facial inflammation
• Dogs had 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/preventative 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 re-presented for enrollment at a later date
• Dogs previously diagnosed (prior to Day 0) as food allergic (with concurrent atopic dermatitis) that 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

STUDY DESIGN¹

• A masked, multisite, well-controlled study of 436 dogs conducted at 26 veterinary clinics in the US evaluated the effectiveness and safety of APOQUEL, dosed orally twice daily (BID) at 0.4 to 0.6 mg/kg for the control of pruritus associated with allergic dermatitis, including flea allergy, food allergy, contact allergy and atopic dermatitis
• Determination of effectiveness was based on the study phase (Days 0-7). The study phase was followed by a continuation phase that lasted up to Day 28 (±2)

STUDY DESIGN⁸

STUDY DESIGN⁵

STUDY DESIGN^6,7