A masked, randomised clinical trial evaluating the efficacy and safety of lokivetmab compared to saline control in client‐owned dogs with allergic dermatitis
Leen Van Brussel, Hilde Moyaert, Monica Escalada, Sean P. Mahabir, Michael Stegemann
Abstract
BACKGROUND: Interleukin (IL)-31 is an important mediator in canine atopic dermatitis (cAD) and also may be dysregulated in other allergic diseases. HYPOTHESIS/OBJECTIVES: To demonstrate the efficacy and safety of lokivetmab (canine anti-IL-31 monoclonal antibody) for treatment of pruritus associated with allergic dermatitis in dogs. ANIMALS: Dogs that were at least moderately pruritic with a presumptive diagnosis of allergic dermatitis were enrolled in Portugal, Hungary, France and Germany by 12 primary care practitioners and two veterinary dermatology referral specialists. METHODS AND MATERIALS: Dogs were randomised to receive either placebo (saline) or lokivetmab (1.0-3.3 mg/kg) by subcutaneous injection on Day (D)0. Owners evaluated pruritus using a validated Visual Analog Scale (pVAS) daily until D7 and then weekly until D28. The severity of dermatitis was assessed by the investigators using a modified VAS on D0, D7, D14 and D28. RESULTS: Beginning at D1, owner-assessed pVAS least square means were significantly reduced in the treatment group versus the placebo group (57.7% versus 21.8% reduction on D28). For all time points, investigator-assessed VAS means were significantly reduced in the lokivetmab group versus the placebo group (57.1% versus 20.5% reduction on D28). Overall, the occurrence of adverse health events during the evaluation period was comparable between the two groups. CONCLUSIONS AND CLINICAL IMPORTANCE: Lokivetmab is a safe and efficacious treatment for dogs with allergic dermatitis.