Perspective

Allergy Department, Hospital Infantil Niño Jesús, Madrid, 28009, Spain

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Fernando Rodríguez Fernández

Allergy Service, Hospital Universitario Marqués de Valdecilla, Santander, 39008, Spain

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Esther Ballester Asensio

Pediatric Pulmonology & Allergy Unit, Dr Peset University Hospital, Valencia, 46017, Spain

Department of Pediatrics, Obstetrics & Gynecology, University of Valencia, Valencia, 46101, Spain

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Miguel Tortajada-Girbés

*Author for correspondence:

E-mail Address: tortajadamig@gmail.com

Pediatric Pulmonology & Allergy Unit, Dr Peset University Hospital, Valencia, 46017, Spain

Department of Pediatrics, Obstetrics & Gynecology, University of Valencia, Valencia, 46101, Spain

IVI Foundation, Valencia, 46026, Spain

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Published Online:1 Dec 2021https://doi.org/10.2217/imt-2021-0251

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Abstract

Management guidelines for allergic rhinitis and urticaria recommend oral second-generation antihistamines as first-line treatment. The efficacy and safety of bilastine, the newest nonsedating second-generation antihistamine, are well established in adolescents/adults with these allergic conditions. The bilastine development program for pediatric use (2–<12 years) followed EMA-authorized processes. Pharmacokinetic/pharmacodynamic simulation and modeling and a pharmacokinetic study were conducted to identify and confirm the pediatric dose (10 mg/day). A Phase III, multicenter, double-blind, randomized, placebo-controlled, parallel-group study was performed to confirm the safety of bilastine 10 mg/day in children. In this article, evidence is reviewed for use of bilastine in children with allergic rhinoconjunctivitis or urticaria. Several cases are presented which demonstrate its role in routine clinical practice.

Keywords:

Papers of special note have been highlighted as: • of interest

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Vol. 14, No. 1

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History

Received 13 September 2021

Accepted 4 November 2021

Published online 1 December 2021

Published in print January 2022

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Keywords

Financial & competing interests disclosure

P Rodríguez del Rio has received lectures fees and advisory board fees from Faes Farma. His institution has received compensation for participating in bilastine clinical trials. F Rodríguez Fernández declares that his institution has received compensation for participating in bilastine clinical trials. E Ballester Asensio declares that her institution has received compensation for participating in bilastine clinical trials. M Tortajada-Girbés declares that his institution has received compensation for participating in bilastine clinical trials. The manuscript elaboration has been funded by Faes Farma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing and editorial assistance for preparation of this article was provided by DP Figgitt, ISMPP CMPP™ and Kerry Dechant, ISMPP CMPP™, on behalf of Content Ed Net, under the direction of the authors; this assistance was funded by Faes Farma.

Patient consent

As all patient data presented in this article were extracted from retrospective analyses of medical records and de-identified, patient consent was not required.

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How bilastine is used to treat allergic rhinitis and urticaria in children

Abstract

References