Safety and Tolerability of Bilastine in the Treatment of Chronic Urticaria in Children
Chronic urticaria is less common in pediatric patients compared to the acute form, but it always requires therapy due to bothersome chronic symptoms that reduce quality of life and disrupt daily activities of affected children. According to recent guidelines, the first-line treatment is non-sedating second-generation antihistamines, among which bilastine is included.
Introduction
In early 2018, recommendations for the diagnosis and treatment of urticaria were updated under the auspices of the European Academy of Allergy and Clinical Immunology (EAACI) and several other professional societies. According to current guidelines, it is recommended to distinguish urticaria by duration as acute (≤ 6 weeks) and chronic (> 6 weeks). In pediatric patients, chronic urticaria is less common compared to the acute form, but due to bothersome chronic symptoms, it always requires therapy.
The therapy of chronic urticaria should be continuous. Second-generation antihistamines are recommended in the first line of treatment due to their good safety profile, long-lasting effect, and minimal adverse effects on cognitive functions. Nevertheless, many physicians still use first-generation antihistamines as the first choice, assuming their safety profile is better known.
Therefore, the review paper assessed the safety and tolerability of the second-generation antihistamine bilastine in the treatment of chronic urticaria in children based on current data.
Safety and Tolerability of Bilastine
Bilastine exhibits a strong and highly selective affinity for H1 histamine receptors. After oral administration, it is rapidly absorbed, with a quick onset of action. Antonijoan et al. demonstrated in their study the onset of bilastine's effect within 1 hour of administration, showing better efficacy in alleviating itching symptoms compared to desloratadine (p < 0.05) and rupatadine (p < 0.01). In pediatric patients, the most common dosage is 10 mg once daily, which has been shown to be equivalent to 20 mg once daily in adults for children aged 2–12 years.
It is not necessary to reduce the dose of bilastine in cases of renal or liver impairment of any severity. The drug does not undergo significant metabolism in the human body, with minimal interactions via the cytochrome P450 (CYP) system. Positron emission tomography has shown almost no occupancy of H1 receptors in the brain, making bilastine an antihistamine that does not penetrate the blood-brain barrier.
The administration of bilastine could therefore be suitable for children where it is essential to minimize the potential impact on cognitive functions. Its tolerability and safety have been confirmed by various clinical studies. For example, Church evaluated the administration of bilastine in more than 3000 patients with urticaria or allergic conjunctivitis. The results showed that long-term administration of the product is safe and well-tolerated, with no sedative effect or cardiotoxicity of bilastine, while its efficacy was comparable to first-generation antihistamines.
The minimum age for bilastine administration varies according to local health authorities and ranges from 6 months to 12 years. In the Czech Republic, it is indicated for children aged 6 years and older with a body weight of at least 20 kilograms.
Conclusion
Bilastine is a second-generation antihistamine indicated for the treatment of chronic urticaria in both children and adults. Long-term administration of the product is associated with a good safety profile and high tolerability. Hence, according to updated guidelines for the treatment of chronic urticaria, bilastine is included in the first line of therapy.
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Sources:
1. Papadopoulos N. G., Zuberbier T. The safety and tolerability profile of bilastine for chronic urticaria in children. Clin Transl Allergy 2019; 9: 55, doi: 10.1186/s13601-019-0294-3.
2. Antonijoan R., Coimbra J., García-Gea C. et al. Comparative efficacy of bilastine, desloratadine and rupatadine in the suppression of wheal and flare response induced by intradermal histamine in healthy volunteers. Cur Med Res Opin 2017; 33 (1): 129–136, doi: 10.1080/03007995.2016.1240665.
3. Church M. K. Safety and efficacy of bilastine: a new H1-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Safe 2011; 10 (5): 779–793, doi: 10.1517/14740338.2011.604029.
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