Safety and clinical efficacy of bilastine in reduction of pruritus in patients with chronic spontaneous urticaria

Abstract

Objective — to evaluate the efficacy/safety of bilastine in relieving pruritus in patients with chronic spontaneous urticaria.
 Materials and methods. This prospective randomized study included 50 adult patients aged 18 to 59 years with chronic spontaneous urticaria and pruritus with an intensity of more than 4 points by the visual analog scale of pruritus assessment in the last 3 days and more than 16 points by the Urticaria activity score 7 (UAS7) which assessed chronic urticaria intensity for the last week.Patients received bilastine orally at a dose of 20 mg once a day for 8 weeks. Patients who did not respond to therapy within the first 2 weeks subsequently received bilastine at a dose of 40 mg per day (two 20 mg tablets) till the end of the study (for 6 weeks).
 Results and discussion. The mean age of patients was 39.61 years with standard deviation (SD) of 12.33 years. In the group of patients who responded positively to the initial therapy, within 8 weeks, the pruritus intensity scoring level decreased significantly to 0.46 (95 % CI: 0.14—0.78) points (p < 0.05). The patients who received a double dose of bilastine also revealed a decrease in the intensity of pruritus and on average on the 8th week of treatment had 0.48 (95 % CI: 0.26—0.70) points (p < 0.05).The study reported 14 adverse events (AE) that occurred during bilastine treatment in 10 (23.8 %) patients. All of them were classified as mild and the most common was headache, registered in 12 (85.7 %) cases. No moderate or severe AEs were reported during the study.
 Conclusions. 8 week treatment with bilastine has demonstrated proven clinical efficacy both in reducing the urticaria activity index according to UAS7 and in reducing the intensity of pruritus in the absence of moderate and severe AEs. Patients who did not respond to starting therapy after doubling the bilastine dose also significantly decreased the urticaria activity index according to UAS7 and reduced the intensity of pruritus. At the same time, increasing the dose of the drug did not lead to an increase in the frequency of AEs.