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APOQUEL® delivered fast relief that began to control itch within 4 hours, comparable to steroids1,2

APOQUEL delivered fast relief that began to control itch within 4 hours, comparable to steroids Apoquel efficacy Itch - 4 hour STUDY DESIGN poquel efficacy Itch - 4 hour INCLUSION CRITERIA

APOQUEL effectively controlled itch within 24 hours in dogs with allergic dermatitis3

APOQUEL effectively controlled itch within 24 hours in dogs with allergic dermatitis Apoquel efficacy Itch - 24 hour STUDY DESIGN Apoquel efficacy Itch - 24 hour INCLUSION CRITERIA

APOQUEL exhibited faster onset of relief than Atopica® (cyclosporine capsules, USP) in the control of pruritus in dogs with atopic dermatitis4,5

APOQUEL exhibited faster onset of relief than Atopica (cyclosporine capsules, USP) in the control of pruritus in dogs with atopic dermatitis Apoquel efficacy Itch - Day 14 STUDY DESIGN Apoquel efficacy Itch - Day 14 INCLUSION CRITERIA

Dogs with atopic dermatitis treated with APOQUEL experienced a significant and long-term reduction in itch6,7

Dogs with atopic dermatitis treated with APOQUEL experienced a significant and long-term reduction in itch Apoquel efficacy Itch - Long Term STUDY DESIGN Apoquel efficacy Itch - Long Term INCLUSION CRITERIA

Indications
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Important Safety Information
Do not use APOQUEL in dogs less than 12 months of age or those with serious infections. APOQUEL may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. APOQUEL has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporine. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. APOQUEL has been used safely with many common medications including parasiticides, antibiotics and vaccines.

For more information, please see the full Prescribing Information.

References: 1. Data on file, Study Report No. A161R-AU-12-096, Zoetis LLC. 2. Gadeyne C, Little P, King VL, et al. Efficacy of oclacitinib (Apoquel®) compared with prednisolone for the control of pruritus and clinical signs associated with allergic dermatitis in client-owned dogs in Australia. Vet Dermatol. 2014;25(6):512-518. doi:10.1111/vde.12166. 3. Cosgrove SB, Wren JA, Cleaver DM, et al. Efficacy and safety of oclacitinib for the control of pruritus and associated skin lesions in dogs with canine allergic dermatitis. Vet Dermatol. 2013;24(5):479-e114. doi:10.1111/vde.12047. 4. Data on file, Study Report No. 6962R-14-10-025, Zoetis LLC. 5. Little PR, King VL, Davis KR, et al. A blinded, randomized clinical trial comparing the efficacy and safety of oclacitinib and cyclosporine for the control of atopic dermatitis in client-owned dogs. Vet Dermatol. 2015;26(1):23-30. doi:10.1111/vde.12186. 6. Cosgrove SB, Wren JA, Cleaver DM, et al. A blinded, randomized, placebo-controlled trial of the efficacy and safety of the Janus kinase inhibitor oclacitinib (Apoquel®) in client-owned dogs with atopic dermatitis. Vet Dermatol. 2013;24(6):587-597. doi:10.1111/vde.12088.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may not have marketing authorization or may have different product labeling in different countries. The animal health information contained herein is provided for educational purposes only and is not intended to replace discussions with an animal healthcare professional. All decisions regarding the care of a veterinary patient must be made with an animal healthcare professional, considering the unique characteristics of the patient.

All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted.

© 2017 Zoetis Services LLC. All rights reserved. APQ-00371

STUDY DESIGN2

  • 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 CRITERIA1

  • 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 DESIGN7

  • 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 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 CRITERIA3

  • 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 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 DESIGN4,5

  • 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:
    1. Owner-assessed pruritus VAS, and
    2. 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 3.1-6.7 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 CRITERIA4

  • 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 DESIGN7

  • 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 CRITERIA6

  • 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 Prelaud’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