Efficacy of p62-expressing plasmid in treatment of canine ATOPIC DERMATITIS: A Pilot study IN companion dogs

Background : Canine Atopic Dermatitis (AD) is a genetically predisposed chronic inflammatory and pruritic allergic skin disease. Despite several drugs for treatment of AD, there are still unmet needs for therapies that have significant clinical response, yet minimal adverse effects. Objective : We have recently developed a plasmid DNA encoding SQSTM1/p62, which demonstrated efficacy in preclinical models of inflammatory diseases as well as in osteoarthritis pain in dogs. Here we test a hypothesis that the p62 plasmid may alleviate severity of AD symptoms associated with the chronic inflammatory nature of the disease. Animals : Twenty privately owned animals with diagnosed severe chronic AD Materials and methods : This was single arm open label study. All dogs were treated with p62 plasmid (1 mg) weekly either intramuscular or subcutaneously (10 dogs in each group) and AD severity by pVAS score was assessed weekly for 11 wks. Results : Treatment with p62 plasmid decreased pVAS score from baseline 8.05+/- 1.36 to 5.52+/- 1.8 (mean+/-SD) with a highly significant statistical difference (P=10 ^-5 ). The effect of the p62 plasmid treatment were developed over time, starting within 2 weeks and with a maximum effect after 7 weeks. Estimated average decrease in pVAS score was 0.23 per week with high statistical significance (). There were no side effects reported. Given the severity of AD, some owners were allowed to continue administration of the same AD medications (steroids or Apoquel®), which they used before. No potential interaction (positive or negative) with p62 plasmid was observed. conclusion and clinical relevance: The p62 plasmid demonstrated modest but statistically significant alleviation of AD in dogs without observed side effects. These results are encouraging to conduct further trials.