Efficacy of APOQUEL® for the Control of Otitis Externa Secondary to Allergic Skin Disease in Client-Owned Dogs

Abstract

BackgroundOtitis externa, an inflammation of the skin of the external ear canal, is a common problem in domestic dogs. Clinical signs of otitis externa include erythema, edema, pain, odor, pruritus, head shaking and excoriations [1,2]. The prevalence of otitis externa has been estimated to be between 7.3 and 10.2% of cases presenting to veterinary clinics [3][4][5][6]. Primary triggers for otitis externa in dogs include atopic dermatitis, food allergy, parasites and foreign bodies, while predisposing factors include conformation of the ear, lifestyle factors causing excessive moisture in the ear canal and inappropriate treatment [7,8]. In a retrospective study that evaluated primary causative factors for otitis externa in patients presented to a veterinary school, allergic dermatitis was the most common primary factor and was observed in 43% of the otitis externa cases evaluated [9]. A similar study found that 60% of dogs presenting with atopic dermatitis had otitis externa [10]. Bacterial infections associated with otitis externa are generally AbstractBackground: This single-arm, unmasked, single-site study was conducted to evaluate the efficacy of oclacitinib (APOQ-UEL®) administered twice daily for 14 days with a topical anti-infective, when indicated, for the control of otitis externa secondary to allergic skin disease in dogs. Thirteen (13) client-owned dogs were enrolled; three (3) dogs were withdrawn for owner non-compliance. Dogs were required to be ≥1 year old, weigh 3.0-80.0 kg, have uncomplicated otitis externa that the Investigator attributed to allergic skin disease, have an Otitis Index Score of ≥6 and been withdrawn from any systemic or topical treatments with antipruritic, anti-inflammatory or anti-infective properties that could interfere with assessments. Cytology samples were collected from each ear. Ears with otitis externa were cleaned at enrollment. Oclacitinib was administered orally twice daily; in dogs with evidence of infection, enrofloxacin/silver sulfadiazine (Baytril ® Otic) was administered topically twice daily in affected ears. Owner assessments were performed daily and Investigator assessments were performed on Days 7 and 14. Results: Seven (7) female and three (3) Conclusions:The results of this single-arm, single-site, unmasked study suggest that oral administration of oclacitinib with a topical anti-infective applied to affected ears twice daily for 14 days is effective for the management of otitis externa secondary to allergic skin disease in dogs.