The Safety and Tolerability Profile of Bilastine for Chronic Urticaria in Children

Overview

Journal Clin Transl Allergy

Publisher Wiley

Specialty Allergy & Immunology

Date 2019 Oct 30

PMID 31660121

Citations 3

Authors

Nikolaos G Papadopoulos

Torsten Zuberbier

Affiliations

Soon will be listed here.

Abstract

Background: Urticaria is a condition defined by the development of wheals, angioedema or both. It is classified based on its duration as acute (≤ 6 weeks) or chronic (> 6 weeks). Chronic urticaria is less frequent than acute one in children, but it represents a debilitating condition, always needing treatment. Symptoms affect child's daily activities and disturb sleeping patterns, causing emotional distress and negatively influencing learning and cognition. Therefore, the management of chronic urticaria must point to a complete control of symptoms, taking into account tolerability and the patient quality of life.

Review Of Literature: The recently revised version of EAACI/GALEN/EDF/WAO guideline on the management of urticaria, in addition to recommending the use of second-generation H antihistamines as the treatment of choice, gives particular attention to their use in the paediatric population. Bilastine has been studied in children; at the dose of 10 mg/once daily, it is licenced for the symptomatic relief of urticaria in children ≥ 6 to 11 years, in the European Union, in appropriate formulation, as oral solution or orodispersible tablet.

Conclusions: In line with the recent guideline recommendation for the use of second generation H antihistamines in children we have reviewed the safety and tolerability profile of bilastine in children with chronic urticaria.

Citing Articles

Development and Evaluation of Cannabidiol Orodispersible Tablets Using a 2-Factorial Design.

Vlad R, Antonoaea P, Todoran N, Redai E, Birsan M, Muntean D Pharmaceutics. 2022; 14(7).

PMID: 35890362 PMC: 9324952. DOI: 10.3390/pharmaceutics14071467.

Bilastine 10 and 20 mg in paediatric and adult patients: an updated practical approach to treatment decisions.

Leceta A, Garcia A, Sologuren A, Campo C Drugs Context. 2021; 10.

PMID: 34457015 PMC: 8366504. DOI: 10.7573/dic.2021-5-1.

Highlights and recent developments in allergic diseases in EAACI journals (2019).

Bousquet J, Grattan C, Akdis C, Eigenmann P, Hoffmann-Sommergruber K, Agache I Clin Transl Allergy. 2020; 10(1):56.

PMID: 33292572 PMC: 7712618. DOI: 10.1186/s13601-020-00366-3.

References

Vozmediano V, Sologuren A, Lukas J, Leal N, Rodriguez M . Model Informed Pediatric Development Applied to Bilastine: Ontogenic PK Model Development, Dose Selection for First Time in Children and PK Study Design. Pharm Res. 2017; 34(12):2720-2734. DOI: 10.1007/s11095-017-2248-6. View

Krishna R, Krishnaswami S, Kittner B, Sankoh A, Jensen B . The utility of mixed-effects covariate analysis in rapid selection of doses in pediatric subjects: a case study with fexofenadine hydrochloride. Biopharm Drug Dispos. 2004; 25(9):373-87. DOI: 10.1002/bdd.425. View

Pampura A, Papadopoulos N, Spicak V, Kurzawa R . Evidence for clinical safety, efficacy, and parent and physician perceptions of levocetirizine for the treatment of children with allergic disease. Int Arch Allergy Immunol. 2011; 155(4):367-78. DOI: 10.1159/000321181. View

Maurer M, Zuberbier T, Siebenhaar F, Krause K . Chronic urticaria - What does the new guideline tell us?. J Dtsch Dermatol Ges. 2018; 16(5):584-593. DOI: 10.1111/ddg.13531. View

Yagami A, Furue M, Togawa M, Saito A, Hide M . One-year safety and efficacy study of bilastine treatment in Japanese patients with chronic spontaneous urticaria or pruritus associated with skin diseases. J Dermatol. 2016; 44(4):375-385. PMC: 5412823. DOI: 10.1111/1346-8138.13644. View

Berger W . The safety and efficacy of desloratadine for the management of allergic disease. Drug Saf. 2005; 28(12):1101-18. DOI: 10.2165/00002018-200528120-00005. View

Zuberbier T, Balke M, Worm M, Edenharter G, Maurer M . Epidemiology of urticaria: a representative cross-sectional population survey. Clin Exp Dermatol. 2010; 35(8):869-73. DOI: 10.1111/j.1365-2230.2010.03840.x. View

Sologuren A, Vinas R, Cordon E, Riesgo S, Del Mar Fores M, Senan M . Open-label safety assessment of bilastine in elderly patients with allergic rhinoconjunctivitis and/or urticaria. Allergy Asthma Proc. 2018; 39(4):299-304. DOI: 10.2500/aap.2018.39.4136. View

Remenyi A, Grosz A, Szabo S, Totka Z, Molnar D, Helfferich F . Comparative study of the effect of bilastine and cetirizine on cognitive functions at ground level and at an altitude of 4,000 m simulated in hypobaric chamber: a randomized, double-blind, placebo-controlled, cross-over study. Expert Opin Drug Saf. 2018; 17(9):859-868. DOI: 10.1080/14740338.2018.1502268. View

10.

Tang N, Mao M, Zhai R, Chen X, Zhang J, Zhu W . [Clinical characteristics of urticaria in children versus adults]. Zhongguo Dang Dai Er Ke Za Zhi. 2017; 19(7):790-795. PMC: 7389927. View

11.

Potter P, Mitha E, Barkai L, Mezei G, Santamaria E, Izquierdo I . Rupatadine is effective in the treatment of chronic spontaneous urticaria in children aged 2-11 years. Pediatr Allergy Immunol. 2015; 27(1):55-61. DOI: 10.1111/pai.12460. View

12.

Conen S, Theunissen E, Van Oers A, Valiente R, Ramaekers J . Acute and subchronic effects of bilastine (20 and 40 mg) and hydroxyzine (50 mg) on actual driving performance in healthy volunteers. J Psychopharmacol. 2010; 25(11):1517-23. DOI: 10.1177/0269881110382467. View

13.

Vozmediano V, Lukas J, Encinas E, Schmidt S, Sologuren A, Valiente R . Model-informed pediatric development applied to bilastine: Analysis of the clinical PK data and confirmation of the dose selected for the target population. Eur J Pharm Sci. 2018; 128:180-192. DOI: 10.1016/j.ejps.2018.11.016. View

14.

Yanai K, Yoshikawa T, Yanai A, Nakamura T, Iida T, Leurs R . The clinical pharmacology of non-sedating antihistamines. Pharmacol Ther. 2017; 178:148-156. DOI: 10.1016/j.pharmthera.2017.04.004. View

15.

Hide M, Yagami A, Togawa M, Saito A, Furue M . Efficacy and safety of bilastine in Japanese patients with chronic spontaneous urticaria: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II/III study. Allergol Int. 2016; 66(2):317-325. DOI: 10.1016/j.alit.2016.08.004. View

16.

Weller K, Ardelean E, Scholz E, Martus P, Zuberbier T, Maurer M . Can on-demand non-sedating antihistamines improve urticaria symptoms? A double-blind, randomized, single-dose study. Acta Derm Venereol. 2012; 93(2):168-74. DOI: 10.2340/00015555-1434. View

17.

Bosma R, van den Bor J, Vischer H, Labeaga L, Leurs R . The long duration of action of the second generation antihistamine bilastine coincides with its long residence time at the histamine H receptor. Eur J Pharmacol. 2018; 838:107-111. DOI: 10.1016/j.ejphar.2018.09.011. View

18.

Tyl B, Kabbaj M, Azzam S, Sologuren A, Valiente R, Reinbolt E . Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol. 2011; 52(6):893-903. DOI: 10.1177/0091270011407191. View

19.

Salmun L, Herron J, Banfield C, Padhi D, Lorber R, Affrime M . The pharmacokinetics, electrocardiographic effects, and tolerability of loratadine syrup in children aged 2 to 5 years. Clin Ther. 2000; 22(5):613-21. DOI: 10.1016/S0149-2918(00)80048-X. View

20.

Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P . Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy. 2009; 65(4):516-28. DOI: 10.1111/j.1398-9995.2009.02217.x. View