Masitinib decreases signs of canine atopic dermatitis: a multicentre, randomized, double‐blind, placebo‐controlled phase 3 trial

Abstract

This study investigated the efficacy and safety of masitinib, a selective tyrosine kinase inhibitor capable of downregulating mast cell functions, for treatment of canine atopic dermatitis (CAD). Dogs with confirmed CAD received masitinib at 12.5 mg/kg/day (n = 202) or control (n = 104) for 12 weeks. A reduction in CAD Extent and Severity Index (CADESI-02) score of ≥ 50% at week 12 was observed in 61% of masitinib-treated dogs versus 35% of control dogs (P < 0.001), according to the modified intent-to-treat population. For dogs resistant to ciclosporin and/or corticosteroids (60% of the study population), CADESI-02 response rates were 60 versus 31%, respectively (P = 0.004). The mean reduction in pruritus score of severely pruritic dogs was 46 versus 29%, respectively (P = 0.045). Furthermore, 65% of owners with severely pruritic dogs assessed masitinib efficacy as good/excellent versus 35% control (P = 0.05). Overall, 63% of investigators assessed masitinib efficacy as good/excellent versus 35% control (P < 0.001). Premature discontinuations from the modified intent-to-treat population (28.2% masitinib versus 26.0% control) were mainly due to adverse events (13.4 versus 4.8%, respectively) or lack of efficacy (12.4 versus 18.3%, respectively). In total, 13.2% dogs presented with severe adverse events (16.0% masitinib versus 7.7% control). Masitinib showed a risk of reversible protein loss, although regular surveillance of blood albumin and proteinuria allowed for discontinuation of treatment while the dog was still clinically asymptomatic. Masitinib proved to be an effective and mostly well-tolerated treatment of CAD, including severe and refractory cases, with medically manageable adverse effects.

Environmental and phenotype-related risk factors for owner-reported allergic/atopic skin symptoms and for canine atopic dermatitis verified by veterinarian in a Finnish dog population

“…Recently, an association between c- KIT , a gene that partakes in mast cell development, and white spots on German shepherd dogs was found [58]. Strong connections between c-KIT and CAD in dogs [59, 60], as well as psoriasis [61] and asthma in humans [62] has also been reported. White Akita-inu dogs [63] and yellow Labrador and golden retrievers [64, 65] have been reported to be homozygous for the R306ter mutation of MC1R , a gene found in melanocytes.…”

Masitinib monotherapy in canine epitheliotropic lymphoma

“…Therefore, patients may benefit from masitinib treatment by palliation of their clinical symptoms without tumour remission. Masitinib has also been proven effective in the treatment of canine atopic dermatitis . Toceranib, another TK inhibitor approved for the use in dogs, has been reported to lead to clinical benefit in tumours that are often associated with inflammatory reactions (e.g.…”

Reliability and agreement in the use of four‐ and six‐point ordinal scales for the assessment of erythema in digital images of canine skin

“…The aim of this study was to investigate the above concepts to determine the reliability and level of agreement between dermatologists when they were asked to grade the severity of erythema using either a four‐category or a six‐category scale. These were chosen because they had been most commonly used in previous studies . It was hypothesized that if veterinary clinicians could accurately discriminate six different grades of erythema, then the reliability and agreement with a six‐category scale would be equal to, or better than, a four‐category scale.…”

“…These were chosen because they had been most commonly used in previous studies. [8][9][10][11][12][13] It was hypothesized that if veterinary clinicians could accurately discriminate six different grades of erythema, then the reliability and agreement with a six-category scale would be equal to, or better than, a four-category scale.…”