Pages: 01-16
Date of Publication: 30-Nov--0001
Asian Experiences in Treating School-Age Children with Bilastine 10 mg Orodispersible Tablets: Cases from Clinical Practice
Author: Marysia Tiongco Recto, Hiroshi Chantaphakul, Kent Woo, Mongkol Lao-Araya, Wong Hoi Ling, Rommel C. M. Lobo, Dinesh Nagrale, Cuc Thi Kim Nguyen, Duy Le Pham, Danilo Poblete, Nuntigar Sonsuwan
Category: Medical Case Reports
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Abstract:
Allergic rhinitis (AR) and chronic urticaria (CU) are prevalent conditions in children worldwide, including in the Asia-Pacific (APAC) region. These conditions are associated with a substantial impact on health-related quality of life (HRQoL), affecting many aspects of children’s daily functioning. Bilastine 10 mg orodispersible tablet (ODT) is a non-sedating second-generation H1-antihistamine indicated in Asia for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria in children aged 6–11 years with a body weight of ?20 kg. Real-world evidence on the use of second-generation H1-antihistamines, particularly bilastine 10 mg ODT, in paediatric populations in APAC remains limited. We present thirteen clinical-practice cases from experienced allergologists, dermatologists, ENT specialists, and paediatricians from APAC, discussed at the STAR NETWORK Expert Panel meeting. The cases illustrate the clinical use, efficacy, and safety of bilastine 10 mg ODT once daily in children aged 6–11 years with AR or CU, across a diverse range of clinical aetiologies and symptoms. Once-daily bilastine 10 mg ODT was found to be effective and well-tolerated in managing AR and CU in school-going children, improving symptom control compared with other antihistamines, without any sedative effects or other adverse events.
Keywords: Asia-Pacific, Bilastine, Chronic Urticaria, Allergic Rhinitis, Orodispersible Tablet
Full Text:
Background
Both allergic rhinitis (AR) and chronic urticaria (CU) are prevalent in children, globally and in the Asia-Pacific (APAC) region (Caffarelli et al., 2020, Schuler Iv and Montejo, 2021). In different epidemiological studies across APAC, the prevalence of AR among children and adolescents was found to range from 9.8% in China to as high as 50% in Taiwan (Chong and Chew, 2018). Most individuals with AR develop symptoms before the age of 20 years, with nearly half of patients becoming symptomatic by the age of 6 years (Meltzer et al., 2009). CU is more prevalent in Asia (1.4%) than Europe (0.5%) and North America (0.1%) (Fricke et al., 2020). In Korea, a nationwide population-based study estimated the prevalence of CU to be 3,253.6 per 100,000 person-years for children aged <10 years (Lee et al., 2017). In some countries, CU primarily affects younger children (Saini et al., 2020, Gon__ampersandsignccedil;alo et al., 2021); in a Thai study of 142 children with CU aged 12 years or younger, 72.6% were below the age of 6 years (Tuchinda et al., 1986).
Both AR and CU are associated with a negative impact on health-related quality of life (HRQoL), affecting many aspects of daily life for children (Gon__ampersandsignccedil;alo et al., 2021, Bosnic-Anticevich et al., 2020). In particular, CU in adults has been shown to have a similar or greater impact on HRQoL than epilepsy, diabetes, moderate-to-severe psoriasis, atopic dermatitis, asthma, and severe coronary artery disease requiring bypass grafting (Gon__ampersandsignccedil;alo et al., 2021, T__ampersandsignouml;ndury et al., 2011). Both AR and CU can disrupt sleep due to nasal congestion, pruritus, and other symptoms, leading to daytime sleepiness and fatigue (Mir et al., 2012, Wasim et al., 2025). Sleep problems in children can impact body weight, memory, attention and performance, as well as behaviour (Liu et al., 2024). Consequently, AR and CU can also have a substantial impact on school performance through increased school absenteeism and distraction during class hours (Mir et al., 2012, Kim et al., 2022, Gon__ampersandsignccedil;alo et al., 2021). In a survey in APAC, nearly half (46%) of patients reported that AR interferes with their ability to perform well at school, leading to a productivity reduction of >20% during periods of peak symptom severity (Katelaris et al., 2011). Similarly, children with CU have a significantly lower school performance than those with other allergic diseases (p=0.029) (Ferrer, 2009). As demonstrated in an Australian study, treatment that leads to good symptom control, leads to considerable improvement in both sleep parameters and school performance (Bosnic-Anticevich et al., 2020).
In addition to symptomatic management, that may include saline sprays or topical lotions, H1-antihistamines are the most commonly prescribed medications for the treatment of AR and urticaria (Simons and Simons, 2011). For more severe cases, intranasal (for AR) and systemic corticosteroids can be added to antihistamine therapy to help manage exacerbations in the short term (Abdullah et al., 2022, Kayiran and Akdeniz, 2019). Second-generation H1-antihistamines are preferred in the management of allergic conditions in children due to their reduced sedative effects compared with first-generation antihistamines (Church and Church, 2011, Parisi et al., 2020). The sedative effects of first-generation drugs can compound the negative effects of AR or CU on children’s school performance, which is not the case with second generation agents (Church et al., 2010). Taste and formulation are important factors in promoting medication adherence among children (Gardiner and Dvorkin, 2006). Paediatric oral dosage forms such as tablets, capsules, solutions, and suspensions can pose several challenges for children, including choking hazards and poor palatability, resulting in low adherence and non-compliance (Kean and Adeleke, 2023). Orodispersible tablet (ODT) formulations disintegrate rapidly in the buccal cavity without the need for water (Kean and Adeleke, 2023). In a study that evaluated dosage form preferences in children and young adults (aged 6–18 years), ODTs were the preferred oral dosage form (58%) (Alyami et al., 2017). By catering for children’s preferences, being easy to use anywhere, without the need for water, and avoiding swallowing issues, ODTs have the potential to promote adherence and thus improve patient outcomes.
Bilastine is a non-sedating second-generation H1-antihistamine, that has shown good efficacy against the symptoms of AR and CU, including improvements in quality of life, as well as a safety profile similar to that of placebo (Ridolo et al., 2015, Leceta et al., 2021). In regions of Asia where paediatric use is approved, bilastine 10 mg ODT is indicated for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria in children aged 6–11 years with a body weight of ?20 kg.
There is currently limited real-word evidence on the use of second-generation H1-antihistamines in general and bilastine in particular in paediatric populations in APAC. Here we have collated case studies to illustrate the real-world clinical use, efficacy and safety of bilastine 10 mg ODT once daily in children (aged 6–11 years) with AR or CU. These cases represent experienced clinicians__ampersandsign#39; perspectives on bilastine application in diverse Asian clinical settings, providing practical insights to complement existing clinical trial evidence.
Methods
The authors of this article are members of the STAR NETWORK Expert Panel, consisting of allergologists (n=5), dermatologists (n=1), ear, nose and throat (ENT) specialists (n=3), and paediatricians (n=2) from the Asia-Pacific region, all of whom routinely manage paediatric patients with AR and CU in clinical practice. The panellists have experience with the management of patients prescribed second-generation H1-antihistamines, including bilastine.
This manuscript presents 13 paediatric case studies from the APAC region that were presented and discussed at the STAR NETWORK Expert Panel meeting, held on 27th June 2025 in Manila, Philippines. The panellists contributed real-world case studies, which were recorded in a predefined template. Inclusion criteria comprised paediatric (aged 6–11 years) case studies involving AR or CU, in which patients were treated with bilastine 10 mg ODT once daily, as per the approved indication. Parental/guardian consent was obtained by the experts for presenting the anonymised case studies. No identity disclosure was made in these cases. This manuscript was collaboratively developed and reviewed by all panellists.
Results
In the presented real-world case studies, paediatric patients were prescribed bilastine 10 mg ODT once daily for the symptom management of AR or CU, as per the label. Patients were aged between 6 and 11 years and 62% were male. Eight of the included patients were diagnosed with AR (Table 1) and five with CU (Table 2).
The primary reason for switching to bilastine 10 mg ODT once daily was an insufficient clinical response to their previous treatment (generally a second-generation antihistamine, in some cases with supportive nasal decongestants or saline sprays, or topical treatments) in seven cases, five AR cases (Case 1, 2, 4, 5, and 8) (Table 1) and two CU cases (Case 10 and 11) (Table 2). In Case 1 (AR), the patient suffered from continued nasal obstruction, which caused daytime somnolence, as well as rhinorrhoea, despite being treated with cetirizine syrup. Four weeks after initiating bilastine 10 mg ODT once daily, the patient reported no sleep disturbances, minimal rhinorrhoea, and no daytime somnolence during school hours or while doing homework. The paediatric patient in Case 2 (AR) was treated with desloratadine, but faced frequent epistaxis, which caused disruption of school attendance. Switching to bilastine 10 mg ODT once daily reduced symptoms so as to be no longer bothersome, allowing the patient to remain focused and active in school. Another child (Case 4, AR) experienced worsening conjunctivitis, despite treatment with desloratadine, which resulted in him not attending school. After initiation of bilastine 10 mg ODT once daily, their symptoms gradually decreased, from a VAS score of 9/10 to 0–1/10 after three months. In Case 5 (AR), the paediatric patient suffered from chronic nasal obstruction, snoring, and poor weight gain while under treatment with cetirizine syrup. Two months after switching to bilastine 10 mg ODT once daily, there was no observable nasal obstruction, and the patient slept quietly. Similarly, despite cetirizine treatment, nasal congestion, rhinorrhoea, and snoring, affecting both sleep and daily activities, continued for Case 8 (AR). Bilastine 10 mg ODT once daily led to marked relief from bothersome symptoms, improved sleep quality and daytime performance, and allowed dose reduction of supporting medications (intranasal steroids). While cetirizine provided some relief of intensely itching lesions for Case 10 (CU), there was no complete clearance, which was also not achieved after switch to desloratadine with supporting treatments (calamine lotion and topical corticosteroids). A switch to bilastine 10 mg ODT once daily was therefore initiated. After two months, the patient reported only minimal hives remaining, and considerable improvements in sleep and itch, with symptoms not being bothersome anymore, allowing full participation in school. The hives and itchy lesions of Case 11 (CU) initially resolved with chlorpheniramine (a first-generation antihistamine) but returned after treatment was stopped. The patient was started on bilastine 10 mg ODT once daily, which resulted in sustained improvements at three months.
Cases 12 and 13 (CU) reported both partial response and daytime sleepiness while on cetirizine. In Case 12, two weeks after changing treatments to bilastine 10 mg ODT once daily, the sedative symptoms had completely resolved, allowing the patient to return to a normal school routine. CU symptom resolution was achieved after six weeks. Similarly, in Case 13, the patient achieved CU symptom improvement within two months of initiating bilastine 10 mg ODT once daily, with no reported side effects.
Case 3 (AR) experienced mild drowsiness on levocetirizine and cetirizine that negatively impacted their school performance. Bilastine 10 mg ODT once daily was therefore initiated and demonstrated improved symptom control.
In Case 6 (overweight patient with AR and adenotonsillar hypertrophy), cetirizine was avoided due to its known association with increased appetite and potential weight gain (Ratliff et al., 2010). Instead, treatment was initiated with bilastine 10 mg ODT once daily, an intranasal corticosteroid, and montelukast. After 6 weeks, the patient’s snoring had markedly decreased, sleep apnoea symptoms had resolved, and a 5% reduction in body weight was achieved.
In Case 7 (AR), the patient had previously struggled with treatment adherence due to the bitter taste of the desloratadine formulation they had been prescribed. Before initiating bilastine 10 mg ODT once daily, the taste was tested in the clinic, and the patient confirmed that they liked it. Since then, adherence to bilastine 10 mg ODT once daily treatment was consistent, and the patient has shown considerable symptom improvement.
The favourable safety profile and absence of immunosuppressive effects of bilastine 10 mg ODT once daily were considered in the treatment choice in Case 1. In Case 6 (AR) and Case 9 (CU), bilastine 10 mg ODT once daily was prescribed as first-line treatment and provided rapid symptom relief, as well as a notable absence of sedation or cognitive side effects.
The most important safety concern raised by patients’ caregivers was drowsiness, affecting the child’s performance at school and participation in activities (Cases 3, 12, and 13). Inconvenience and potential long-term effects of cetirizine syrup were considered by parents in Case 8, contributing to the choice of bilastine 10 mg ODT once daily. Safety concerns were also raised by carers about supportive treatments, some of which could be discontinued or their dose reduced, upon initiation of bilastine (Case 3). Loteprednol could be discontinued in Case 4.
Table 1: Cases of AR treated with bilastine 10 mg ODT OD.
Abbreviations: AR, allergic rhinitis; BID, twice daily; CBC, complete blood count; ENT, ear nose and throat; IgE. Immunoglobulin E; OD, once daily; ODT, orodispersible tablet; OTC, over-the-counter; PT, prothrombin time; PTT, partial thromboplastin time; VAS, visual analogue scale.
Table 2: Cases of CU treated with bilastine 10 mg ODT OD.
Abbreviations: AR, allergic rhinitis; BID, twice daily; CU, chronic urticaria; GP, general practitioner; HSS7, Hives Severity Score over 7 days; ISS7, Itch Severity Score over 7 days; OD, once daily; ODT, orodispersible tablet; UAS, Urticaria Activity Score; UAS7, Urticaria Activity Score over 7 days; UCT, Urticaria Control Test.
Discussion
The presented collection of real-world case studies demonstrates that treatment with bilastine 10 mg ODT in Asia, administered once daily as per the label in children aged 6–11 years, for the symptomatic treatment of AR and CU, was effective and well tolerated. The main reason for selecting bilastine in these diverse case studies was insufficient clinical response to other, mostly second generation, antihistamines. In all these cases, a switch to bilastine 10 mg ODT once daily resulted in marked improvement or resolution of symptoms. Other reasons for switching to or using bilastine included concerns about sedative effects of other antihistamines (including other second-generation antihistamines), which were effectively avoided through the use of bilastine 10 mg ODT once daily. The pleasant taste of the bilastine 10 mg ODT once daily formulation, as well as its ease of use, were a key deciding factor in one case. In all cases, both patients and carers expressed their satisfaction with bilastine 10 mg ODT once daily, based on symptom improvement, resolution of side effects of other medications, reduction of the need for concomitant medications, as well as taste and convenience. Parents/carers in this case series expressed their safety concerns about medications for children, particularly regarding immunosuppressive and sedating effects. Based on results from multiple research groups, bilastine is categorised as a ‘non-sedating antihistamine’ and classified as a ‘non-brain penetrating antihistamine’, which is in line with our findings. Across the 13 case studies presented here, there were no reports of sedation associated with bilastine. Patients were able to maintain or return to their regular daily activities, including attending school. The safety observations we made here are also in keeping with the results of a large Phase 3 randomised clinical trial involving children aged 2–11 years with allergic rhinoconjunctivitis or CU, in which the primary hypothesis, that there was non-inferiority between bilastine 10 mg ODT once daily and placebo with regard to safety and tolerability (Nov__ampersandsignaacute;k et al., 2016). A previous case study from the Original Real-world cases of Bilastine in Treatment (ORBIT) study, reported that bilastine 10 mg once daily was effective and well-tolerated in a 10-year-old male patient with chronic spontaneous urticaria and recurrent hives (Cheong et al., 2022).
Medication taste is a key barrier to treatment adherence, especially for paediatric patients, as children are often more sensitive to bitter tastes than adults (Mennella et al., 2013). In one of the presented cases, the child failed to adhere to a previous treatment due to its bitter taste. A taste test showed that the child liked the taste of bilastine 10 mg ODT, and there were no further adherence issues. Furthermore, the taste of bilastine was not a reported as a concern in any of the case studies, suggesting that all patients found the taste pleasant or acceptable.
Some children may struggle to take common oral dosage forms at home, such as tablets or capsules, due to choking hazards or fear (Kean and Adeleke, 2023). While syrups are widely available, they have some drawbacks; they are more difficult to carry, there is a risk of spillage during administration, they can be less stable than tablets, and the wrong dose may be administered, and susceptible to dosing errors. The ODT formulation of bilastine 10 mg allows children to easily self-administer the treatment. The water-free administration also enables use on the go, which may further support treatment adherence. This was reflected in Case 3, where the 8-year-old patient identified ease of administration as a key benefit of switching to bilastine 10 mg ODT once daily. Furthermore, the fixed dosage of bilastine 10 mg ODT allows for more precise dosing, reducing the risk of dosing errors.
In our cases, bilastine 10 mg ODT once daily improved patients__ampersandsign#39; quality of life across multiple domains: physical wellbeing through resolution of sleep problems (Cases 1, 5, 6, 8, 10) and bothersome symptoms; mental/cognitive wellbeing through elimination of daytime somnolence and drowsiness (Cases 1, 3, 12, 13); and social wellbeing through restored school attendance/performance (Cases 1, 2, 10) and participation in daily activities (Case 2).
We present a small number of retrospectively collected data from cases from real-world clinical practice, which are based on individual clinical experiences. They were not part of a clinical trial or case series and may not be generalizable to the broader patient population. The reported outcomes may be influenced by patient-specific factors, clinician judgment, and contextual variables and should be interpreted with caution.
Conclusion
Our findings from a diverse range of case studies in AR and CU, involving school-going children with different clinical aetiologies and symptoms, demonstrate that bilastine 10 mg ODT once daily is both effective and well tolerated in managing these conditions in children aged 6–11 years, improving symptom control compared with other antihistamines, without any sedative effects or other adverse events. The palatability and ease of administration of the ODT formulation may support treatment compliance in paediatric patients.
Acknowledgements
The face-to-face STAR NETWORK expert meeting and development of this manuscript were sponsored by Menarini Asia Pacific Pte Ltd. The authors received honoraria and support from Menarini Asia Pacific Pte Ltd for transportation and accommodation for the STAR NETWORK expert meeting. Menarini also provided support staff at the meeting and funded medical writing support from Clarivate for the development of the manuscript.
Authors’ Contribution Statement
Conceptualization: Marysia Tiongco Recto, Hiroshi Chantaphakul, Kent Woo, and Dinesh Nagrale
Investigation (Contributed Case Study Presentations): Mongkol Lao-Araya, Wong Hoi Ling, Rommel C. M. Lobo, Cuc Thi Kim Nguyen, Duy Le Pham, Danilo Poblete, and Nuntigar Sonsuwan
Writing – Original Draft Preparation: Clarivate
Writing – Review and Editing: Marysia Tiongco Recto, Hiroshi Chantaphakul, Kent Woo, Mongkol Lao-Araya, Wong Hoi Ling, Rommel C. M. Lobo, Dinesh Nagrale, Cuc Thi Kim Nguyen, Duy Le Pham, Danilo Poblete, and Nuntigar Sonsuwan.
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