Detalle Publicación

Efficacy and Safety of Omalizumab (Xolair) for Cholinergic Urticaria in Patients Unresponsive to a Double Dose of Antihistamines: A Randomized Mixed Double-Blind and Open-Label Placebo-Controlled Clinical Trial

Autores: Gastaminza Lasarte, Gabriel; Azofra, J.; Núñez Córdoba, Jorge María; Baeza, M. L.; Echechipia, S.; Gaig, P.; Garcia, B. E.; Labrador Horrillo, M.; Sala Cunill, A.; Sabaté Brescó, Marina; Beristain, A.; Quiñones, D.; Díaz Donado, C.; Zubeldia, J. M.; Ferrer Puga, Marta (Autor de correspondencia)
ISSN: 2213-2198
Volumen: 7
Número: 5
Páginas: 1599-1609
Fecha de publicación: 2019
BACKGROUND: Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature. OBJECTIVE: To explore the safety and efficacy of omalizumab in controlling UCOL. METHODS: We conducted a multicenter randomized mixed double-blind and open-label (first 4 months blinded followed by 8 months open-label) placebo-controlled clinical trial in 22 patients suffering from UCOL who were unresponsive to a double dose of antihistamines. We performed an exercise challenge test during each visit as our main outcome variable. RESULTS: The overall rate of exercise challenge test negative at week 48 was 31.3%, with an average increase in exercise challenge test negative rate of 2.9% points (95% CI, 1.5-4.2) per visit. Statistically significant differences in the negative exercise challenge test rate between the placebo and active intervention groups were not observed during the blinded period (first 4 months of the study). However, from the fourth dose, a progressive improvement was observed. When comparing before and after treatment, statistically significant improvements in all secondary outcome measures were noted after 4 doses (UCOL score: P = .0015; visual analog scale score: P = .0108; days with symptoms: P [.0125) and after 8 doses (UCOL score: P = .0005; chronic urticaria quality of life questionnaire: P = .0105; visual analog scale score: P = .0008; and days with symptoms: P = .0144). In the followup visit after the cessation ...