Veterinary dermatology · 2015
Long-term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life.
Клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Cosgrove Sallie B, Cleaver Dawn M, King Vickie L, Gilmer Amy R, Daniels Anne E, Wren Jody A, Stegemann Michael R
Аннотация
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.
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.