Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo in the treatment of perennial allergic rhinitis

Abstract

Objective:

Bilastine is a non-sedating second-generation H₁ antihistamine with proven efficacy and safety in the treatment of patients with seasonal allergic rhinitis and urticaria. The objective of this study was to demonstrate the efficacy and safety of bilastine in patients with perennial allergic rhinitis (PAR).

Methods:

In a multicenter, randomized, placebo-controlled, double-blind, parallel-group study, patients with symptomatic PAR (n = 650) from Argentina, Europe, and South Africa received bilastine 20 mg, cetirizine 10 mg, or placebo once daily for 4 weeks. The primary efficacy outcome was the mean area under the curve (AUC) of reflective total 6-symptom scores (rT6SS) from baseline visit to day 28 (D28). Secondary outcome measures included mean AUC of instantaneous total 6-symptom scores (iT6SS), and mean AUCs of reflective and instantaneous total 4-nasal symptom scores (T4NSS) and total 2-ocular symptom scores (T2OSS) from baseline to D28. An open-label extension phase evaluated the safety of bilastine 20 mg administered to patients (n = 513) for one year.

Results:

In the overall population no significant differences in efficacy outcomes were found between active treatments and placebo. On account of the high placebo response in South Africa, a post-hoc analysis was conducted. This analysis demonstrated that statistically significant differences existed between active treatments and placebo in the mean AUC of rT6SS (p < 0.05) and T4NSS (p < 0.02), respectively, from baseline to D28 visit for the intent-to-treat population in patients from Europe and Argentina, whereas the difference was not statistically significant in South Africa. Whether this is related to differences in the demographic or clinical characteristics of South African patients (they had PAR for longer and reported more severe symptoms) and/or the disease management process compared with their European and Argentinean counterparts warrants further investigation.

Conclusions:

A post-hoc analysis indicated that bilastine and cetirizine were similarly effective and more effective than placebo during a 4-week treatment period in patients with PAR. In addition, bilastine was shown to be safe and well-tolerated over a 1-year treatment period.

Clinical trial registry number:

NCT01127620.

Keywords::

• Bilastine
• Cetirizine
• H₁ antihistamine
• PAR
• Perennial allergic rhinitis

Transparency

Declaration of funding

This study was supported by Faes Farma SA, Bilbao, Spain.

Declaration of financial/other relationships

J.S. reports having served as a consultant to Phadia, Schering-Plough, Faes Farma, and GSK, has been paid lecture fees by Novartis, GSK, Stallergenes, UCB, and has received grant support from Phadia, GSK, and ALK-Abello. A.V. reports having served as a consultant to MSD, Stallergenes, Uriach Pharma, Esteve and Faes Farma, has been paid lecture fees by Novartis, GSK, Stallergenes, MSD, Uriach Pharma and AstraZeneca, and has received grant support from Phadia and Uriach Pharma. J.M. has been a member of national and international scientific advisory boards, and has received fees for lectures and grants for research projects from Boheringer-Ingelheim, Esteve, Faes, Hartington Pharmaceuticals, MSD, Novartis, Schering Plough, UCB, Uriach SA, Zambon, GSK. R.V. is an employee at Faes Farma.

Acknowledgments

Bilastine Study Group: Dr Roque Gustavo Arnolt, Dr Rene Bailleau, Dr Carlos Crisci, Dr Alicia de Falco, Dr Alfredo Gandur, Dr Maximiliano Gómez, Dr Edgardo Jares, Dr Juan C Ivancevich, Dr Miguel Lisanti, Dr Iris Medina, Dr Gustavo Rojido, Dr Pedro Vucovich, Dr Anahi Yáñez, Dr Hugo Neffen, Dr Germán Ramón, Dr Teresa Adamek-Guzik, Dr Radoslaw Janiak, Dr Piotr Kuna, Dr Stanislaw Mazur, Dr Bernard Panaszek, Dr Donata Rys, Dr Wojciech Skucha, Dr Roxana Bumbacea, Dr Silvia Samuilla, Dr Camelia Berghea, Dr Adriana Iacomi, Dr Paula Ivan, Dr Cristian Radu Popescu, Dr Raluca Dragusin, Dr Viorel Zainea, Dr Mihaela Negrila, Dr Gloria Davis, Dr L Myers, Dr Marcelle Groenewald, Dr LM Hofmayr, Dr LA Jacobsz, Dr Andrew Jacovides, Dr GH Gabriel, Dr JZ Moolman, Dr WA van der Walt, Dr Emlyn L Janari, Dr Peta L Jearey, Dr D Clarke, Dr GJW Datziel Dr Deepak R Lakha, Dr Andrew H MacLeod, Dr Hemant A Makan, Dr UG Desai, Dr Winifred E Mans, Dr AM Nel, Dr Somasundram Pillay, Dr Paul C Potter, Dr SA Emanuel, Dr ZFA Hawarden, Dr Jacob D Smit, Dr PR Nel, Dr Jacques R Snyman, Dr R Cuyler, Dr NG Mareledwane, Dr JP Meeding, Dr NP Ratau, Dr Zubar FA Vawda, Dr Adie Viljoen, Dr Monserrat de Molina, Dr Ester Pinto, Dr Antonio Basomba, Dr Inmaculada GVillamanzo, Dr Ana Giner, Dr Ramón Almero, Dr Miguel Baltasar, Dr Carmen Vidal, Dr Virginia Vázquez, Dr José Luis Justicia, Dr Maria J Barasona, Dr Carlos Blanco, Dr Javier Figueroa.

Editorial Advisory Committee: Dr I Dávila, Dr I Jáuregui Dr J Bartra, Dr M Ferrer, Dr A del Cuvillo, Dr J Montoro.

Editorial assistance: The authors thank Content Ed Net for editorial assistance.