Introduction

Allergic rhinoconjunctivitis and chronic urticaria are common conditions in young children (<12 years) and carry a large burden of disease. Bilastine is a second-generation oral H1 antihistamine approved for use at a once-daily dose for symptomatic treatment of allergic rhinoconjunctivitis and urticaria.

Aim

To assess the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria

Patient Profile

• 509 children aged 2–11 years with a documented history of allergic rhinoconjunctivitis or chronic urticaria and with clinical symptoms at study entry

Method

Study Design

• Phase III, multicentre, double-blind randomized, placebo-controlled, parallel-group study
• Children received bilastine 10 mg oral dispersible tablet once-daily or placebo for 12 weeks
• Occasional rescue medication was allowed in the form of short-term topical decongestants, corticosteroids or antihistamines for rhinoconjunctivitis, or short-term topical corticosteroids for urticaria

Endpoints

• Primary analysis: proportion of children in each treatment group without treatment-emergent adverse events (TEAEs)
• Secondary analysis: proportion of children with related TEAEs, incidence of TEAEs, laboratory blood tests, assessment of cardiac safety by electrocardiogram (ECG), and assessment of somnolence/sedation with the Pediatric Sleep Questionnaire (PSQ)

Results

Safety 

• Bilastine 10 mg was non-inferior to placebo 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%, Figure 1)
• No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for TEAEs or related TEAEs in the population overall or by age subgroup
• Most of the related TEAEs were mild to moderate in intensity (92% for bilastine 10 mg and 86% for placebo)
• The most commonly reported TEAEs (frequency ≥5% in any treatment group) were headache, cough, pharyngitis, allergic conjunctivitis, nasopharyngitis and pyrexia
• TEAEs led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo
• No clinically and/or statistically relevant differences were seen between bilastine 10 mg and placebo for vital signs, clinical laboratory values, ECG parameters or physical examination
• PSQ scores for somnolence/sedation decreased slightly from baseline to week 12 in both the bilastine 10 mg and placebo groups; between-group differences were not significant for the total score or for scores in the individual domains

Figure 1: Comparison of the effect of bilastine and placebo on the primary analysis variable

Conclusion

Bilastine 10 mg exhibited safety and tolerability profile similar to that of placebo in children aged 2 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Pediatr Allergy Immunol 2016: 27: 493–498