A Blinded, Randomized, Placebo-Controlled Trial of the Safety of Oclacitinib in Cats
Ensaio cego, randomizado e controlado por placebo sobre a segurança do oclacitinibe em gatos
Natália Lôres Lopes, Diefrey Ribeiro Campos, Marília Alves Machado, Mariana Silva Revoredo Alves,Manuela Silva Gomes de Souza, Cristiano Chaves Pessoa da Veiga, Alexandre Merlo, Fábio Barbour Scott, Julio Israel Fernandes
Background: Oclacitinib is a Janus kinase (JAK) 1 enzyme inhibitor and blocks JAK1-dependent cytokines and isused to control pruritus. Studies available in cats are very limited and as there is a potential role for oclacitinib inthe control of pruritus in this specie, the aim of this study was to evaluate the safety and clinical effects of oraloclacitinib maleate in healthy cats.
Results: Thirty mixed-breed cats weighing from 2.1 to 5.3 kg each were randomly allocated to three treatmentgroups of 10 animals each. Cats in two groups received oclacitinib at 1 mg/kg or 2 mg/kg q 12 h orally for 28 days.Cats in the third group were given placebo tablets (cornstarch) q 12 h orally for 28 days. Oclacitinib maleate waswell tolerated during the study and few adverse events were observed in treated cats. Clinical signs of toxicity werenot observed in any animals treated at 1 mg/kg. Gastrointestinal clinical signs observed in the 2 mg/kg groupincluded vomiting in two of the 10 cats and soft stools in two cats. One cat treated with placebo also exhibitedsoft stools. No significant differences were observed between the groups for hematologic analyses performedduring the study. There was a slight increase in neutrophils and monocytes and a decrease in eosinophil meancounts in treated cats. Mean renal and liver enzymes remained normal throughout the entire study. A small, butsignificant increase in fructosamine levels was observed for both treated groups compared with placebo; however,values remained within the normal reference range. There were no significant difference between treated groupsand the placebo group for urine specific gravity, pH, or urine protein to creatinine ratio mean values.
Conclusions: Oclacitinib maleate was well tolerated by cats at 1 mg/kg and 2 mg/kg and appeared to be safe forthis species when administered orally twice daily for 28 days. More studies would be needed to demonstrate ifoclacitinib maleate may be a suitable alternative to treat pruritic cats.
Cats, Clinical effects, Feline, Oclacitinib, Pruritus, Safety
Gatos, Efeitos clínicos, Felino, Prurido, Segurança