Masitinib decreases signs of canine atopic dermatitis: a multicentre, randomized, double‐blind, placebo‐controlled phase 3 trial
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.
Document Type: Research Article
Affiliations: 1: Clinique vétérinaire Europa, Boulogne Billancourt, France 2: Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA 3: Clinique vétérinaire, Cesson-Sévigné, France 4: Unité de Parasitologie, Ecole Nationale Vétérinaire d’Alfort, Unité Mixte de Recherche BIPAR, UMR AFSSA-ENVA-UPEC-LERPAZ, Maisons-Alfort, France 5: Cabinet vétérinaire, Spa, Belgium 6: Clinique vétérinaire, Bruxelles, Belgium 7: Clinique vétérinaire, Choisy-Le-Roy, France 8: Facultatea de Medicina Veterinara, Bucarest, Roumania 9: University of Illinois, Urbana-Champaign, IL, USA 10: Animal Dermatology and Allergy, Sacramento, CA, USA 11: Southwest Veterinary Dermatology, Houston, TX, USA 12: Veterinary Skin and Allergy Specialists, Englewood, CO, USA 13: Clinique vétérinaire des Alizés, Abymes, France 14: AB Science, Paris, France
Publication date: December 1, 2011