title: 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.
authors.affiliation: Clinique vétérinaire Europa, Boulogne Billancourt, France. cadot.pierrej@wanadoo.fr
authors.forename: Pierre
authors.initials: P
authors.lastname: Cadot
authors.forename: Patrick
authors.initials: P
authors.lastname: Hensel
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Bensignor
authors.forename: Céline
authors.initials: C
authors.lastname: Hadjaje
authors.forename: Geneviève
authors.initials: G
authors.lastname: Marignac
authors.forename: Luc
authors.initials: L
authors.lastname: Beco
authors.forename: Jacques
authors.initials: J
authors.lastname: Fontaine
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Jamet
authors.forename: Gabriela
authors.initials: G
authors.lastname: Georgescu
authors.forename: Karen
authors.initials: K
authors.lastname: Campbell
authors.forename: Andréa
authors.initials: A
authors.lastname: Cannon
authors.forename: Sarah C
authors.initials: SC
authors.lastname: Osborn
authors.forename: Linda
authors.initials: L
authors.lastname: Messinger
authors.forename: Michel
authors.initials: M
authors.lastname: Gogny-Goubert
authors.forename: Patrice
authors.initials: P
authors.lastname: Dubreuil
authors.forename: Alain
authors.initials: A
authors.lastname: Moussy
authors.forename: Olivier
authors.initials: O
authors.lastname: Hermine
mesh_terms: D000818:Animals; D001549:Benzamides; D003876:Dermatitis, Atopic / Q000188:drug therapy / Q000662:veterinary*; D004283:Dog Diseases / Q000188:drug therapy*; D004285:Dogs; D004311:Double-Blind Method; D004334:Drug Administration Schedule / Q000662:veterinary; D005260:Female; D008297:Male; D010880:Piperidines; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011725:Pyridines; D012720:Severity of Illness Index; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D001549:Benzamides; D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011725:Pyridines; D013844:Thiazoles; C526575:masitinib