Long‐term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life

Abstract

Background -Oclacitinib is safe and effective for treating dogs with pruritus associated with allergic and atopic dermatitis, based on randomized clinical trials of up to 4 months duration.Hypothesis/Objectives -This study assessed long-term safety, efficacy and quality of life of oclacitinib-treated dogs enrolled in a compassionate use programme.Animals -Two hundred and forty-seven client-owned dogs with allergic skin disease that had previously benefited from oclacitinib therapy.Methods -Dogs were enrolled in an open-label study at 26 veterinary clinics. Dogs received 0.4-0.6 mg/kg oclacitinib twice a day for 14 days, then once a day for up to 630 days. Assessments were performed at~90 day intervals. Owners completed a quality-of-life survey and assessed pruritus using a Visual Analog Scale (VAS) at each clinic visit. Veterinarians assessed dermatitis using a similar VAS. Abnormal health events, concomitant medication and clinical pathology results were summarized.Results -Visual Analog Scale scores showed improvement from baseline at all time points. The percentage of dogs showing ≥50% reduction from baseline on day 90 was 63.9% for pruritus and 66.4% for dermatitis. Owners saw a positive impact on quality of life in >91% of all dogs. Urinary tract infection/cystitis, vomiting, otitis, pyoderma and diarrhoea were the most frequently reported (>5% of dogs) abnormal clinical signs. Haematology and serum chemistry means remained within the normal reference ranges. Concomitant medications were well tolerated.Conclusions and clinical importance -Results indicated that oclacitinib was safe and efficacious for long-term use and improved the quality of life for dogs in this study.

The frequency of urinary tract infection and subclinical bacteriuria in dogs with allergic dermatitis treated with oclacitinib: a prospective study

“…An open label trial reported urinary tract infection/cystitis to occur in 28 of 247 (11.3%) oclacitinib‐treated allergic dogs . Systemic antibiotic drugs were permitted during the study.…”

“…Oclacitinib has been shown to block the effects of IL‐6, a cytokine involved in the signalling pathway emanating from toll‐like receptor 4 in bladder epithelial cells, along with IL‐8, which in theory could lead to a decreased defence against urinary pathogens . Abnormal urinary tract signs described as “cystitis” in dogs receiving oclacitinib have been reported at a frequency of 0.5–11.3% . Quantitative urine cultures, the gold standard in confirming a UTI, were not evaluated in these studies to assess bacteriuria .…”

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

“…The dose of oclacitinib (0.4 to 0.6 mg oclacitinib/kg body weight twice daily) was determined using the dosing chart on the package insert [14]. The oclacitinib dose was administered directly into the mouth or in a small amount of food.…”

“…Oclacitinib is currently approved for the control of pruritus associated with allergic dermatitis and for the control of atopic dermatitis in dogs that are at least 12 months of age [13]. Oclacitinib has been shown to be safe and effective for long-term use in dogs with atopic and allergic skin disease [14]. The present study was designed to evaluate the potential for oclacitinib to aid in the control of otitis externa in dogs with allergic skin disease.…”

Canine cancer immunotherapy studies: linking mouse and human

“…Another notable agent which has been approved for a veterinary indication without corresponding approval in humans is oclacitinib (Apoquel®), a Janus Kinase 2 inhibitor, approved for refractory allergic dermatitis in dogs. The mechanisms by which oclacitinib work in dogs is comparable to JAK inhibitors used in humans for myelodysplastic syndrome and rheumatoid arthritis (with similar side effects) [95]. …”