Bilastine and its role in the treatment of allergic rhinoconjunctivitis and urticaria in children
The prevalence of allergic rhinitis (AR) in the pediatric population is estimated worldwide at 10-20%. The efficacy and safety of bilastine (a second-generation antihistamine) in adult patients and adolescents have already been proven in clinical studies. Below we summarize experiences with its use in children under 12 years of age.
Second-generation antihistamines as first-line drugs in the treatment of AR
Second-generation antihistamines (cetirizine, desloratadine, ebastine, fexofenadine, levocetirizine, loratadine, rupatadine, and the latest bilastine) are among the first-line drugs in the therapy of allergic rhinoconjunctivitis and urticaria.
Bilastine has been shown to have a high affinity for H1 receptors. Its rapid onset (1-1.5 hours) and long-lasting effect (at least 24 hours) are advantageous. Unlike first-generation antihistamines, it does not penetrate the blood-brain barrier and therefore does not have sedative effects. Dose adjustment is not necessary for patients with renal and liver impairment, and it also has minimal drug interactions.
Efficacy and safety of bilastine in children in clinical studies
It has been shown that exposure to bilastine at a dose of 10 mg in children aged 6 to 11 years with a body weight of at least 20 kg is equivalent to exposure to 20 mg of bilastine in adults. Currently, bilastine is approved in Europe for the treatment of patients aged 6 years and older.
Efficacy and safety were confirmed in a phase III clinical study. This was a multicenter double-blind randomized placebo-controlled study, including a total of 509 children aged 2-11 years with allergic rhinitis (94.1% of participants) or chronic urticaria (5.9% of participants). They were given either 10 mg of bilastine (n = 260) or placebo (n = 249) daily for 3 months. Children were randomized by age into 3 groups: 2 to < 6 years (20%), 6 to < 9 years (40%), and 9 to < 12 years (40%). No significant difference was found in the incidence of adverse events between the bilastine and placebo groups. The most common adverse events were headache, cough, allergic conjunctivitis, (naso)pharyngitis, or pyrexia.
Drug forms and administration
Bilastine is available in 20mg and 10mg orally dispersible tablets. This allows choosing an appropriate dosage form according to the patient's age and preferences.
It is advisable to take bilastine on an empty stomach, i.e., 1 hour before or 2 hours after a meal. Its rapid absorption has been demonstrated on an empty stomach, while co-administration with food reduces the bioavailability of oro-dispersible tablets by up to 20%.
Case reports from real practice
An 8-year-old boy suffered from allergic rhinitis caused by a house dust mite allergy. Lifestyle measures were insufficient. Therefore, he used an antihistamine other than bilastine but felt sleepy at the standard dosing. After consulting a neurologist, the therapy was changed to nasal corticosteroids, which the patient could not tolerate due to his age. Symptom improvement occurred after 1 month of taking bilastine at a dose of 10 mg once daily.
A 10-year-old girl was diagnosed with cold urticaria. During the cold winter months, she was tormented by itching, which significantly limited her daily life. She felt tired when taking another antihistamine, so she was recommended to take bilastine at a dose of 10 mg in the form of orally dispersible tablets. This treatment relieved her itching and improved her quality of life without adverse effects, including sleepiness.
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Sources:
1. Rodríguez del Río P., Rodríguez Fernández F., Ballester Asensio E., Tortajada-Girbés M. How bilastine is used to treat allergic rhinitis and urticaria in children. Immunotherapy 2022; 14 (1): 77-89, doi: 10.2217/imt-2021-0251.
2. SPC Xados. Available at: www.sukl.cz/modules/medication/detail.php?code=0132113&tab=texts
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