Head to head study of Zenrelia and Apoquel in dogs with atopic dermatitis study design3
A randomized, controlled, multi-site, blinded non-inferiority study of 338 client-owned dogs assessing the efficacy and safety of Zenrelia for the treatment of pruritus or skin lesions in dogs diagnosed with atopic dermatitis, compared to a positive control, Apoquel.
Sites: 25
Original duration: 56 days
Option to extend to 112 days (154 dogs included)
Both products were given according to directions
- Apoquel: twice daily for 14 days, then once daily through conclusion of study
- Zenrelia: once daily
Primary endpoints
- Percentage reduction from baseline in the owner-assessed PVAS on Day 28
- Percentage reduction from baseline in CADESI-4 skin lesion score on Day 28
Additional endpoints
- Proportion of dogs with 50% reduction from baseline in CADESI-4 and PVAS during study
- Owner and Investigator RTT during study
- Dogs with ≥2 unit reduction in owner-assessed PVAS (D1–7, and each visit)
- CADESI-4 scores at each visit
- Mean PVAS scores
- Proportion of dogs achieving clinical remission for pruritus (PVAS<2)
Head to head study of Zenrelia and Apoquel in dogs with atopic dermatitis inclusion criteria3
- Client-owned dogs, age ≥12 months, weight ≥3.0 kg diagnosed with atopic dermatitis, not pregnant, lactating or intended for breeding
- Exclusion of diseases resembling atopic dermatitis including food allergies, flea allergy dermatitis, primary bacterial or fungal dermatitides and/or otitis, internal/external parasitism, metabolic disease and others, as appropriate
- At least moderate pruritus (PVAS score ≥6.0)
- At least mild skin lesions (CADESI 4 score of ≥35)
- Physically healthy, free of a serious/systemic disease that would interfere with study objectives. Allowance for systemic disease if well-controlled and treated for ≥6 weeks before enrollment
- No evidence of fleas. Flea control required during study for all dogs (most recent dose at least 7 days prior to enrollment)
- A variety of other medications were allowed during the study, including antiparasitic drugs, vaccinations, shampoos or ear cleansers, canine prescription diets, nutritional products, and topical or otic products (if they did not contain a steroid)
- Must not have malignant neoplasia, demodicosis or immune suppression (e.g., hyperadrenocorticism)
- No known sensitivity to JAK inhibitors
- Prohibited concomitant medication or observed wash-out periods that could impact study (glucocorticoids, cyclosporine, etc.)
- The most frequently administered concomitant medications were: parasiticides, vaccines, antibiotics, antifungals, NSAIDs, ear cleaners, sedatives/anesthetics, and dietary supplements such as pre- and pro-biotics.
US Atopic Dermatitis Field Study Design2
A double-blind, randomized, placebo-controlled, multi-site field study to assess the efficacy and safety of Zenrelia for the treatment of pruritus or skin lesions in 268 dogs diagnosed with atopic dermatitis.
Animals that met the study inclusion criteria were randomized in a 2:1 ratio to receive daily oral doses of Zenrelia or placebo for up to 28 days, with an optional continuation phase up to 112 days.
Administration: Zenrelia was administered at a label dose (0.27–0.36 mg/lb [0.6–0.8 mg/kg], once daily) up to Day 112
Visits: Visits occurred on Days 14, 28, 56, 84, and 112
Primary endpoint
- Treatment success on Day 28, defined as: at least 50% reduction from baseline in either owner-assessed PVAS scores or investigator-assessed CADESI-4 scores
Additional endpoints
- Proportion of dogs with at least 50% reduction from baseline in CADESI-4 and PVAS during study
- Overall response to treatment, assessed by the owner as well as by the investigator
- Mean PVAS scores
- Proportion of dogs achieving clinical remission for pruritus (PVAS <2)
US Atopic Dermatitis Field Study Inclusion Criteria2
- Client-owned dogs, age ≥12 months, weight ≥3.0 kg diagnosed with atopic dermatitis, not pregnant, lactating or intended for breeding
- Exclusion of diseases resembling atopic dermatitis including food allergies, flea allergy dermatitis, primary bacterial or fungal dermatitides and/or otitis, internal/external parasitism, metabolic disease and others, as appropriate
- At least moderate pruritus (PVAS score ≥6.0)
- At least mild skin lesions (CADESI 4 score of ≥25)
- Atopic dermatitis diagnosis based on Hensel’s guidelines and dog meeting ≥6 of Favrot’s criteria
- Physically healthy, free of a serious/systemic disease that would interfere with study objectives. Allowance for systemic disease if well-controlled and treated for ≥6 weeks before enrollment
- No evidence of fleas. Flea control required during study for all dogs (and for flea endemic areas, most recent dose at least 7 days prior to enrollment)
- Must not have malignant neoplasia, demodicosis or immune suppression (e.g., hyperadrenocorticism)
- No known sensitivity to JAK inhibitors
- Prohibited concomitant medication or observed wash-out periods that could impact study (glucocorticoids, cyclosporine, etc.)
- The most frequently administered concomitant medications were: parasiticides, vaccines, antibiotics, antifungals, NSAIDs, ear cleaners, sedatives/anesthetics, and dietary supplements such as pre- and pro-biotics.
INDICATIONS
Zenrelia is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
IMPORTANT SAFETY INFORMATION
Read the entire package insert before using this drug, including the Boxed Warning.
For full prescribing information call 1-888-545-5973 or visit http://www.elancolabels.com/us/zenrelia
WARNING: VACCINE-INDUCED DISEASE AND INADEQUATE IMMUNE RESPONSE TO VACCINES. Based on results of the vaccine response study, dogs receiving Zenrelia are at risk of fatal vaccine-induced disease and inadequate immune response to vaccines. Discontinue Zenrelia for at least 28 days to 3 months prior to vaccination and withhold Zenrelia for at least 28 days after vaccination. Dogs should be up to date on vaccinations prior to starting Zenrelia. Do not use in dogs less than 12 months old or dogs with a serious infection. Monitor dogs for infections because Zenrelia may increase susceptibility to opportunistic infections. Neoplastic conditions (benign and malignant) were observed during clinical studies. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. The most common adverse reactions were vomiting, diarrhea and lethargy. Zenrelia has not been evaluated in breeding, pregnant, or lactating dogs and concurrent use with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents has not been tested. For full prescribing information see package insert.
