Pharmacokinetics and Safety Profile of Bilastine in Patients Aged 6–11 Years – Findings from Post-hoc Analysis of Studies
The second-generation antihistamine bilastine is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in children over 6 years old. Post-hoc analyses of two clinical studies focused on its safety profile and pharmacokinetics in the pediatric population.
Analyzed Studies
Bilastine is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults and children aged ≥ 6 years with a body weight of ≥ 20 kg. The European Journal of Pediatrics published the results of a post-hoc analysis of bilastine's pharmacokinetic properties, based on an international multicenter study where bilastine was orally administered at a dose of 10 mg/day to children aged 4−11 years with allergic rhinoconjunctivitis and urticaria. The post-hoc safety profile analysis was derived from a phase III randomized double-blind placebo-controlled study involving children aged 2–11 years with similar diagnoses, taking either bilastine 10 mg/day or placebo for 12 weeks.
Pharmacokinetic Properties
Available data allowed for the analysis of absorption, distribution, and elimination of bilastine in the pediatric population. Maximum plasma concentration (Cmax) values for 10 mg bilastine daily were similar to those in adult subjects taking 20 mg bilastine daily. The median Cmax in the pediatric population was 212.0 ng/ml, compared to 232.5 ng/ml in the adult population. For the AUC0−24 (area under the concentration-time curve from 0 to 24 hours), values of 1045 ng × hr/ml and 1121 ng × hr/ml were observed.
Safety Profile
The primary aim of the analyzed study was to evaluate the number of children with no observed adverse effects during 3 months of treatment and 1 month of follow-up. In the bilastine group (n = 202, average age 8.5 years, 98% with allergic rhinoconjunctivitis, and 2% with urticaria), 137 adverse events were recorded in 67.8% of the children. In the placebo control group (n = 191, average age 8.5 years, 93.7% with allergic rhinoconjunctivitis, and 6.3% with urticaria), there were 129 cases in 67.5% of the children (p = 0.952).
The most frequent adverse event with a frequency ≥ 5% was headache in both groups (13.4% in the bilastine group and 12.6% in the control group). This was followed by allergic conjunctivitis (9.9% vs. 9.4%), cough (8.9% vs. 7.9%), and further included nasopharyngitis, pharyngitis, allergic rhinitis, fever, and viral infections.
No significant differences in adverse event occurrence between the groups were observed. The results of the analysis confirm that bilastine at a dose of 10 mg has a similar tolerability and safety profile as placebo in children.
Conclusion
The analysis of bilastine's pharmacokinetics and safety indicates that this medication at a dose of 10 mg is suitable for the age group 6–11 years and that its good safety profile similar to placebo, and favorable pharmacokinetic properties, support its use in pediatric patients with allergic rhinoconjunctivitis and urticaria.
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Source: Rodríguez M., Vozmediano V., García-Bea A. et al. Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria. Eur J Pediatr 2020 Jan 9, doi: 10.1007/s00431-019-03559-6 [Epub ahead of print].
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