Efficacy and safety of bilastine in reducing pruritus in patients with chronic spontaneous urticaria and other skin diseases: an exploratory study

Abstract

Purpose: To evaluate the efficacy/safety of bilastine in pruritus relief in patients with chronic spontaneous urticaria (CSU) or other pruritic skin diseases.

Methods: In this multicenter, open-label, exploratory study (EudraCT No.: 2016-001505-17), 115 adults with CSU (n = 34), eczema/dermatitis (n = 30), prurigo (n = 25) or cutaneous pruritus (n = 26), received bilastine 20 mg once daily for 8 weeks, or in non-responder patients (<30% improvement in pruritus score at week 2), 40 mg/day from week 2.

Results: The mean change in weekly pruritus severity score from baseline to week 8 (primary endpoint) was reduced with bilastine (overall and by disease group); overall, percentage and absolute reductions were 71.16% and 1.63 points, respectively (p < .001). Updosed non-responders (n = 31) had improved weekly pruritus severity scores from baseline to week 8; percentage and absolute reductions were 49.08% and 1.13 points, respectively (p < .001). Bilastine improved the Dermatology Life Quality Index at weeks 4 and 8 (p < .001) in all disease groups, and the 7-day Urticaria Activity Score in CSU patients (p < .001). Bilastine was well tolerated.

Conclusions: Bilastine relieved pruritus associated with urticaria and other skin diseases, with a very good safety profile.

Keywords:

• Bilastine
• chronic spontaneous urticaria
• pruritus
• skin diseases
• updosing

Acknowledgments

The authors thank Robert A. Furlong PhD and David P. Figgitt PhD, ISMPP CMPP™, Content Ed Net, for providing medical writing and editorial assistance, with funding from FAES FARMA S. A., Spain.

Disclosure statement

Bernadetta Majorek-Olechowska and Esther Serra-Baldrich have not declared any conflict of interest. Zoltan Novak has been a member of the advisory boards of different pharmaceutical companies: AstraZeneca, GlaxoSmithKline, Berlin-Chemie and also usually gives lectures for the same companies. Cristina Campo, Aintzane García-Bea, and Luis Labeaga are full-time employees of FAES FARMA S. A.

Additional information

Funding

The study was supported by FAES FARMA S. A., Spain.