Papadopoulos NG, Zuberbier T.

Clin Transl Allergy. 2019 Oct 23;9:55. doi: 10.1186/s13601-019-0294-3. eCollection 2019. Review.

Urticaria is characterized by the development of pruritic wheals, angioedema or both. Guidelines from early 2018 recommend that urticaria is classified based on its duration as acute (< 6 weeks) or chronic (> 6 weeks). In addition, they also classify chronic urticaria as spontaneous or inducible. Chronic urticaria is less frequent than acute in children, but is a condition that requires treatment, as it affects children’s daily activities, disturbs sleep, causes emotional distress and influences negatively learning and cognition.

Bilastine is a H1-antihistamine that has been studied in children at the dose of 10mg/daily and is licensed for the symptomatic relief of urticaria symptoms in children > 6 to 11 years.

Investigation in paediatric population included bilastine and rupatadine among the second-generation antihistamines. A phase III, doubleblind, randomized, placebo-controlled, parallel-group clinical trial was carried out to assess the safety and tolerability of bilastine 10 mg once daily for 12 weeks in 509 children aged 2–11 years with allergic rhinitis or chronic urticaria. The primary endpoint was the proportion of children in each treatment group without treatment-emergent adverse events (TEAEs). Secondary endpoints included the assessment of somnolence/sedation with the Pediatric Sleep Questionnaire (PSQ). No statistically significant differences were found between treatment groups for incidences of TEAEs or related TEAEs in the population overall or by age subgroup. The majority of related TEAEs were mild to moderate in intensity. PSQ scores for somnolence/sedation decreased slightly from baseline to week 12 in both the bilastine 10 mg and placebo groups.

In conclusion, bilastine is a suitable for treatment of urticaria in children, due to its efficacy and good tolerability profile that were proven in well-controlled studies. Specifically, lack of potential to induce sedation allows prolonged administration without impairment of performance and learning abilities.

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