Establishing the place in therapy of bilastine in the treatment of allergic rhinitis according to ARIA: evidence review

Abstract

Background:

The ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines development group examined the properties of oral H₁-antihistamines and made proposals about an ‘optimal’ drug. Several criteria should be met by oral H₁-antihistamines in terms of their pharmacological, and clinical efficacy and safety profiles.

Objective:

Bilastine, a new H₁-antihistamine, has been approved in 28 European countries for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria in adults and children older than 12 years. To determine its potential place in therapy in the treatment of allergic rhinitis, this manuscript examines whether bilastine meets the criteria defined in the European Academy of Allergy and Clinical Immunology (EAACI)/ARIA proposals for oral H₁-antihistamines.

Methods:

The optimal properties of oral H₁-antihistamines and current ARIA recommendations for their use in allergic rhinitis are presented, as well as relevant pharmacological and clinical data for bilastine obtained from the published literature that specifically address the defined criteria.

Results:

Bilastine is a potent inhibitor of the histamine H₁ receptor. Data from preclinical studies have confirmed its selectivity for the histamine H₁ receptor over other receptors, and demonstrated antihistaminic properties in vitro and in vivo. Bilastine does not interfere with the cytochrome P450 system and is devoid of cardiac side effects. Studies in healthy volunteers and patients have shown that bilastine does not affect driving ability, cardiac conduction or alertness. In large pivotal randomized, placebo-controlled trials (RCTs), bilastine had a favourable safety profile. Bilastine 20 mg once daily improved all nasal and ocular symptoms of allergic rhinitis with greater efficacy than placebo and comparable to that of cetirizine and desloratadine. Moreover, bilastine was shown to improve quality of life, an important outcome of RCTs in allergic diseases. There were no significant changes in laboratory tests, electrocardiograms or vital signs. A potential limitation of this assessment of bilastine is that it is a literature-based review and the findings are dependent upon the quality of the published evidence.

Conclusions:

Bilastine meets current EAACI/ARIA criteria for medications used in the treatment of allergic rhinitis.

Key words::

• Allergic rhinitis
• ARIA
• Bilastine
• Efficacy
• Guidelines
• Non-sedating antihistamine
• Safety

Transparency

Declaration of funding

This review was supported by FAES Farma, Bilbao, Spain.

Declaration of financial/other relationships

J.B. is a member of the FAES Farma Advisory Board and reports having served as a consultant/advisor to Actelion, Almirall, AstraZeneca, Chiesi, GSK, Merck, OM Pharma, Sanofi, Teva, Uriach, Meda and Novartis.

I.A. is a member of the FAES Farma Advisory Board, and reports having served as a consultant/advisor to Bial-Aristegui, FAES Farma, Sanofi and Johnson & Johnson, and having served on the speakers’ bureaux of Bial-Aristegui, FAES Farma, AstraZeneca.

W.C. is a member of the FAES Farma Advisory Board, and reports having served as a consultant/advisor to Boehringer Ingelheim, Novartis and ALK-Abello, and has received grant support from Chiesi, ALK-Abello, AstraZeneca, Lallemand and Stallergenes.

T.Z. is a member of the FAES Farma Advisory Board and reports having served as a consultant/advisor or having received grant support and/or honoraria from Ansell, Bayer, Schering, DST, Fujisawa, HAL, Henkel, Kryiolan, Leti, MSD, Novartis, Procter and Gamble, Sanofi Aventis, Schering Plough, Stallergenes and UDB.

C.B. reports having served as a consultant/advisor to Procter and Gamble, Stallergenes, FAES Farma and Uriach, and having served on the speakers’ bureaux of UCB, GSK, MSD and Allergan.

M.M. has received grant support from FAES Farma, GSK, MSD and Pfizer.

J.M. reports having been a member of national and international scientific advisory boards, has received fees for lectures and grants for research projects from Boehringer-Ingelheim, Esteve, FAES Farma, Hartington Pharmaceuticals, MSD, Novartis, Schering Plough, UCB, Uriach, Zambon and GSK.

D.P.R. reports having served as a consultant/advisor or having received grant support and/or honoraria from Astra Zeneca, MSD, Orion Health, Novartis, GSK, ALK-Abello, Boehringer, Chiesi and Uriach.

M.S. has served on the speakers’ bureau of FAES Farma.

R.V. is an employee of FAES Farma.

M.K.C is a member of the FAES Farma Advisory Board and has served on the speakers’ bureau of UCB.

C.E.B. reports having served as a consultant/advisor or having received grant support and/or honoraria from Phoenix Argentina, Sanofi, Lofarma and FAES Farma.

The rest of the authors have no conflicts of interest to declare.

All authors, except R.V. are members of ARIA (Allergic Rhinitis and Its Impact on Asthma) initiative.

Acknowledgements

The authors thank Content Ed Net for editorial assistance.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.