United States

pivotal data demonstrating efficacy and safety of apoquel® published in veterinary dermatology

APOQUEL® Rapidly Stops Itch Associated with Atopic Dermatitis in Dogs

FLORHAM PARK, N.J. – November 25, 2013 – Pivotal data recently published online in the December issue of Veterinary Dermatology demonstrates that APOQUEL® (oclacitinib tablet) provides rapid and long-term relief from pruritus and inflammation associated with atopic dermatitis in dogs, without many of the side effects commonly associated with other therapies.

APOQUEL, was approved by the U.S. Food and Drug Administration in May 2013 and is the first Janus kinase (JAK) 1 inhibitor approved for veterinary use. Its novel mode of action specifically targets and inhibits the cytokines involved in itch and inflammation with minimal activity against cytokines involved in hematopoiesis or innate immune function.

“Previously available treatments have helped manage itch in dogs with atopic dermatitis, but have either a delayed onset of action or unacceptable side effects,” said Sallie Cosgrove, M.S., D.V.M, Associate Director, Veterinary Medicine R&D at Zoetis and US Clinical Team Lead for the study. “This study shows that APOQUEL helps control itch within the first day of treatment and can be safely and effectively used over time without many of the side effects observed with other treatments.”

Canine atopic dermatitis (AD) is one of the most common allergic dermatoses diagnosed by veterinarians. The key therapeutic goal when treating atopic dermatitis is to quickly and reliably stop the itch to prevent further skin damage, and improve the quality of life for both the dog and owner. In addition, the control of inflammation and dermatitis is needed in order to see an improvement in skin condition.

About the Study

“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” was designed in support of a new drug registration to evaluate the safety and efficacy of APOQUEL. Eighteen board-certified veterinary dermatologists in the United States enrolled a total of 299 dogs 1 year of age or older to receive APOQUEL or excipient-matched placebo at a dose of 0.4-0.6 mg/kg twice-daily for 14 days, and then once-daily at the same dose for up to 112 days.

Owners assessed visual analog scale (VAS) scores of pruritus, while veterinarians assessed Canine AD Extent and Severity Index (CADESI-02) scores. For both owners and veterinary dermatologists, VAS and CADESI-02 scores were significantly better in oclacitinib-treated dogs compared to placebo-treated dogs at all time points.

The anti-itch effect was rapid and long-lasting, with owners reporting a mean 29.5% reduction in pruritus in APOQUEL-treated dogs within 24 hours compared to only a 6.5% reduction for placebo-treated dogs. By day 14, the reduction in pruritus was 67% with APOQUEL treatment compared to 3.9% in the placebo-treated dogs.  The improvement in lesion scores was similarly rapid, with a 48.4% reduction in CADESI-02 scores (compared to a 1.7% decrease in placebo-treated dogs) after only 14 days of treatment.

Treatment success for Owner Pruritus VAS was defined as at least a 2 cm reduction (using a 10 cm VAS) from baseline and veterinarian CADESI at least 50% reduction in dermatitis on Day 28 of the study. At day 28, owner VAS scores showed the majority of APOQUEL-treated dogs (66%) were considered to be a treatment success and veterinarian CADESI-02 scores showed 49% of APOQUEL-treated dogs achieved a treatment success, as compared to 4% of the placebo-treated dogs for both measures.

After day 28 and through day 112 of the study, both VAS and CADESI-02 scores continued to improve in the APOQUEL-treated dogs, while success rates remained constant.

“Adverse events such as diarrhea, vomiting, anorexia and lethargy were mild and infrequent in APOQUEL-treated dogs, and occurred with similar frequency in the placebo-treated dogs. In most cases, the adverse events spontaneously resolved and did not require that dosing be discontinued which was also similar to the placebo-treated dogs,” Cosgrove said.  Additionally, the study showed APOQUEL can be used in combination with a wide variety of concomitant medications, vaccines and flea products and no drug-drug interactions appeared to be associated with APOQUEL administration.

About APOQUEL

APOQUEL is a targeted new approach to rapidly and safely stop the cycle of itch and inflammation associated with allergic skin disease in dogs. Zoetis announced the U.S. Food and Drug Administration approval of APOQUEL on May 16, 2013. APOQUEL is the only animal health product approved for both the control of pruritus associated with allergic dermatitis and the control of atopic dermatitis in dogs over 12 months of age. APOQUEL is proven to effectively reduce itch within 24 hours and provide long-term relief with minimal side effects.

Zoetis plans to make APOQUEL available to veterinarians by the First Quarter 2014. During the coming months, Zoetis will be educating veterinarians on the new science associated with canine allergic diseases to lay the groundwork for a successful launch. For more information, please visit www.apoquel.com. As the latest addition to the company’s diverse portfolio of companion animal medicines, this approval signifies an important milestone for this leading animal health company.

Important Safety Information

APOQUEL® should not be used in dogs less than 12 months of age or in dogs with serious infections. APOQUEL may increase the susceptibility to infection and demodicosis and may exacerbate neoplastic conditions. APOQUEL has not been evaluated in combination with systemic immunosuppressive agents such as glucocorticoids or cyclosporine. APOQUEL should not be used in breeding dogs, or pregnant or lactating dogs. The most common side effects seen in dogs administered APOQUEL were vomiting and diarrhea. APOQUEL has been safely used in conjunction with other common medications including antibiotics and parasiticides and with vaccinations. For Full Prescribing Information visit http://www.apoquel.com/Apoquel_PI.

About Zoetis

Zoetis (zō-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on a 60-year history as the animal health business of Pfizer, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products and genetic tests and supported by a range of services. In 2012, the company generated annual revenues of $4.3 billion.  With approximately 9,300 employees worldwide at the beginning of 2013, Zoetis has a local presence in approximately 70 countries, including 29 manufacturing facilities in 11 countries. Its products serve veterinarians, livestock producers and people who raise and care for farm and companion animals in 120 countries. For more information on the company, visit www.zoetis.com.

Zoetis is the proud sponsor with the Smithsonian Institution Traveling Exhibition Service and the American Veterinary Medical Association of the mobile educational exhibit Animal Connections: Our Journey Together.  Families visiting the exhibit will explore the vast bonds between people and animals and learn about the important role veterinarians play in protecting animal and human health. 

FOR IMMEDIATE RELEASE 

Media Contacts:

Deron Johnson
Zoetis
973-822-7203
Deron.Johnson@zoetis.com

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