Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases

Abstract

Background Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10‐mg dose of bilastine in children aged 2 to <12 years provided an equivalent systemic exposure as 20 mg in adults. The current study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria. Methods In this phase III, multicentre, double‐blind study, children were randomized to once‐daily treatment with bilastine 10‐mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks. Safety evaluations included treatment‐emergent adverse events (TEAEs), laboratory tests, cardiac safety (ECG recordings) and somnolence/sedation using the Pediatric Sleep Questionnaire (PSQ). Results The primary hypothesis of non‐inferiority between bilastine 10 mg and placebo was demonstrated on the basis of a near‐equivalent proportion of children in each treatment arm without TEAEs during 12 weeks' treatment (31.5 vs. 32.5%). No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for TEAEs or related TEAEs, ECG parameters and PSQ scores. The majority of TEAEs were mild or moderate in intensity. TEAEs led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo. Conclusions Bilastine 10 mg had a safety and tolerability profile similar to that of placebo in children aged 2 to <12 years with allergic rhinoconjunctivitis or chronic urticaria.

The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria

“…Only medications with proven efficacy and safety in the paediatric population should be used. Cetirizine, desloratadine, fexofenadine, levocetirizine, rupatadine, bilastine and loratadine have been well studied in children, and their long‐term safety has been well established in the paediatric population. In addition, the choice of the modern 2 nd ‐generation H 1 ‐antihistamines in children depends on the age and availability as not all are available as syrup or fast dissolving tablet suitable for children.…”

The role and choice criteria of antihistamines in allergy management – expert opinion

“…None of the conducted clinical trials showed any influence of bilastine on the morphology of the ECG signal and QTc interval. Thus, it could be stated that the cardiovascular safety of bilastine is very high, and the influence of the drug on morphology of the ECG signal and cardiac muscle repolarization is the same as that of placebo [10, 15, 32–44]. …”

The role and choice criteria of antihistamines in allergy management – Expert opinion

“…The first trial showed that bilastine in the dose of 10 mg used in children aged 2-12 gave the same (equivalent) exposure as the dose of 20 mg in adults [77]. The second study, in children aged below 12 with allergic rhinoconjunctivitis or with chronic urticaria, indicated safety and tolerability (similar to placebo) of bilastine in the dose of 10 mg used for 12 weeks [44].…”

“…None of the conducted clinical trials showed any influence of bilastine on the morphology of the ECG signal and QTc interval. Thus, it could be stated that the cardiovascular safety of bilastine is very high, and the influence of the drug on morphology of the ECG signal and cardiac muscle repolarization is the same as that of placebo [10,15,[32][33][34][35][36][37][38][39][40][41][42][43][44].…”