United States
Print page content Print
Increase text size Decrease text size
Text Size
Apoquel Logo

Adverse Events

Allergic Dermatitis

Atopic Dermatitis

APOQUEL vs Atopica (cyclosporine capsules, USP)

Atopica is a registered trademark of Eli Lilly and Company, its subsidiaries and affiliates.

APOQUEL vs Atopica (cyclosporine capsules, USP) STUDY DESIGN

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. 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. 2. Data on file, Study Report No. A161R-AU-12-096, Zoetis LLC. 3. 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. 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. 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.

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 DESIGN1

  • A masked multisite, well-controlled study of 436 dogs conducted at 26 veterinary clinics in the United States 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 DESIGN6

  • 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, prednisone, dosed at 0.50-1.0 mg/kg SID for up to Day 6 (±1), followed by 0.50-1.0 mg/kg EOD

STUDY DESIGN3

  • 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)

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: (i) Owner-assessed pruritus VAS and (ii) Investigator-assessed CADESI-02, each incorporating a non-inferiority test at Day 28 (±2)