A blinded, randomized clinical trial evaluating the efficacy and safety of lokivetmab compared to ciclosporin in client‐owned dogs with atopic dermatitis

Abstract

Background -Lokivetmab is an injectable anti-canine-IL-31 monoclonal antibody to treat clinical manifestations of atopic dermatitis (AD) in dogs.Hypothesis/Objectives -To characterize the efficacy and safety of lokivetmab, and to demonstrate its noninferiority to ciclosporin under field conditions. Animals -Dogs with chronic AD (n = 274) were enrolled from 40 practices in Belgium, The Netherlands, France and Germany.Methods -Animals were randomized (1:1) to oral ciclosporin (5 mg/kg/once daily) or monthly injectable lokivetmab (1-3.3 mg/kg) for three months. Eighty one animals that successfully completed the comparative phase were enrolled in a continuation phase receiving lokivetmab for an additional six months. Owners assessed pruritus on a Visual Analog Scale, skin lesions were assessed by veterinary investigators with a Canine AD Extent and Severity Index (CADESI-03) scale. Results -Lokivetmab was noninferior to ciclosporin for pruritus reduction on Day 28 (51.90% versus 43.72%).For Day 28 CADESI-03 percentage reduction, noninferiority of lokivetmab (54.17) versus ciclosporin (56.86%) was not achieved. At none of the time points were mean CADESI-03 scores significantly different between groups. Continued efficacy towards pruritus and lesions was demonstrated in the continuation phase where 76.3% of animals (n = 45) were assessed as 'normal' for pruritus at study end. No abnormal health events associated with lokivetmab were observed during the initial three month phase (142 dogs) or during the subsequent six month phase (81 dogs).Conclusions and clinical importance -Lokivetmab at a minimum monthly dose of 1 mg/kg provided quick onset (within one day) of a lasting effect in reducing pruritus and skin lesions with a good safety profile.

The influence of treatment with lokivetmab on transepidermal water loss (TEWL) in dogs with spontaneously occurring atopic dermatitis

“…Another study evaluated the effectiveness of lokivetmab administered monthly using CADESI-03 and the Pruritus Visual Analog Scale (PVAS); there was a significant reduction in the CADESI-03 (from 184 to 57) after 12 weeks of treatment. 13 The decrease was greatest after the first administration of the drug (CADESI-03 reduced from 184 to 76 after four weeks; 54% reduction). This finding is similar to our study where the largest decrease, in CADESI-04, was also recorded after four weeks (from 36.6 to 11.1; 69% reduction).…”

“…The duration of the effect on pruritus was 49 days and for CADESI‐03 it was eight weeks. Another study evaluated the effectiveness of lokivetmab administered monthly using CADESI‐03 and the Pruritus Visual Analog Scale (PVAS); there was a significant reduction in the CADESI‐03 (from 184 to 57) after 12 weeks of treatment . The decrease was greatest after the first administration of the drug (CADESI‐03 reduced from 184 to 76 after four weeks; 54% reduction).…”

“…Lokivetmab (Cytopoint, Zoetis Belgium SA; Louvain‐la‐Neuve, Belgium) is a caninized anti‐IL‐31 antibody that binds circulating IL‐31 and prevents its binding to the receptor. The subcutaneous (s.c.) administration of lokivetmab to atopic dogs has been reported to reduce pruritus for four weeks and in the improvement of skin lesions, based on the assessment of the third iteration of CADESI(‐03) …”

“…The subcutaneous (s.c.) administration of lokivetmab to atopic dogs has been reported to reduce pruritus for four weeks and in the improvement of skin lesions, based on the assessment of the third iteration of CADESI(-03). 13,14 This aim of this study was to assess TEWL in atopic dogs over the course of 12 weeks of treatment with lokivetmab and its correlation with the CADESI-04 scoring system and an evaluation of the severity of pruritus.…”

Pharmacotherapy of canine atopic dermatitis - current state and new trends

“…Based on the findings related to oclacitinib, a specific caninized antibody against the Th-2 and pruritus inducing cytokine IL-31 (Lokivetmab) was recently launched. In a comparative study with cyclosporine A, lokivetmab was not inferior in reducing itching and lesions (20). However, some dogs were "nonresponders" with regard to the lesions.…”