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New FDC therapy enhances AR symptoms and QoL in paediatric patients

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AR is a chronic inflammatory disorder, characterised by an immunoglobulin E-mediated (IgE) inflammatory response triggered by allergen exposure in sensitised individuals. AR affects the nasal mucosa, causing episodes of repeated sneezing, rhinorrhoea and nasal congestion, often accompanied by itching of the eyes, nose and palate. AR is classified as seasonal or perennial, intermittent, or persistent based on symptom duration and frequency.2,3,4 

Photograph of two children holding nasal spray
Viatris' introduction of the FDC azelastine/fluticasone nasal spray marks a significant milestone in the management of paediatric AR in South Africa. [Source: Shutterstock]

According to McDonald and De Waal, AR is often misdiagnosed as viral rhinosinusitis or upper respiratory tract infections (URTIs) in paediatric patients. Untreated AR can lead to serious complications in this patient population including otitis media, recurrent sinusitis and sleep apnoea. In children living with comorbid asthma, AR can lead to poorly controlled symptoms and unnecessary prescriptions for antibiotics and oral CS.4,5  

Allergen triggers can be identified using skin-prick testing and serum IgE-measurement – but this should be performed early. However, noted McDonald and De Waal, in certain emerging AR phenotypes such as local AR, these procedures may have negative results and a nasal allergen challenge should be performed.4 

Impact of AR on paediatric patients 

According to McDonald and De Waal, the prevalence of AR in young paediatric patients is unknown. However, AR symptoms can present in children from as young as 24-months, and as mentioned, are often misdiagnosed. Some experts, do however, report an increase in AR prevalence of around 2% per year of age.5  

AR has a profound impact on the quality of life (QoL) of paediatric patients as well as their caregivers.  A study by Blaiss et al showed that AR negatively impacts several aspects on day-to-day living such as functioning, sleep, absenteeism, school productivity and academic performance.6  

Meltzer et al found that adolescents living with AR have high rates of somatisation, anxiety and depression, less resistance to stressful situations, and exhibit more hostility, impulsivity and rapid changes in interest. Parental assessment of the impact of AR on the day-to-day lives of paediatric patients living with AR indicates that AR makes their child unhappy, upset, angry and embarrassed.7 

A more recent study by Bosnic-Anticevich et al showed that paediatric patients living with AR have a worse overall health status, fewer days being happy, more days of poor physical and emotional health compared with their counterparts not affected by the disease. AR negatively impacts schoolwork, sleep and other activities. Children accomplished less than they would usually have done at school or in other activities, and a reduced level of care is noticeable when performing schoolwork or other activities.3  

AR is also associated with an increased risk of comorbidities.  A recent study showed that allergic conjunctivitis (71.7%) is the most common comorbidity in paediatric patients with severe AR, followed by adenotonsillar hypertrophy (54.1%), sinusitis (49.2%), asthma (46.7%), otitis media (40.8%), atopic dermatitis (20%), chronic tonsillitis (9%), and obstructive sleep apnoea syndrome (4.5%).3,8   

Four pillars of effective management 

Bosnic-Anticevich et al, the outcomes demonstrated in their study, were significantly worse in paediatric patients living with inadequate symptom control. Effective AR treatment comprises four important pillars: 4,5  

  1. Patient education 
  2. Practical allergen-avoidance strategies 
  3. Pharmacotherapy  
  4. Allergen immunotherapy.   

 

In terms of pillar 4, intranasal CS (INCS) are recommended as first-line treatment for paediatric patients living with AR, effectively managing both intermittent and persistent symptoms such as nasal congestion, runny nose, and sneezing.5   

INCS are more effective than first-generation antihistamines (AH) and leukotriene receptor antagonists, particularly in moderate-to-severe AR cases. INCS options such as fluticasone propionate and fluticasone furoate have the lowest systemic bioavailability.5   

For children >6-years with difficult-to-control symptoms, a combination of AH and INCS is recommended. First-generation AH are not recommended due to their side effects. Second-generation AH can be used as add-on therapy to INCS, especially when itching, sneezing, and runny nose predominate.5 

Nasal decongestants should be used cautiously due to the risk of rhinitis medicamentosa. The use of oral CS is discouraged, and over-the-counter formulations should be avoided.5 

How safe and effective are combination therapy? 

Li et al conducted a study to assess the efficacy and safety of monotherapy versus combination therapy for AR, aimed at providing evidence-based guidance for pharmacotherapy.9  

Their meta-analysis revealed that the combination therapy group exhibited a percentage improvement of 95.2% compared to the monotherapy group, suggesting a greater efficacy in reducing total nasal symptom scores (TNSS) in patients living with AR.9 

Furthermore, individual nasal symptom scores were significantly reduced in the combination therapy group compared to the monotherapy group. Importantly, there were no significant differences in the incidence of adverse events, such as headache, dysgeusia, and epistaxis, between the two groups.9 

The authors concluded that combination therapy significantly improves nasal symptoms in patients living with AR compared to monotherapy, with similar incidence of adverse events between the two groups. The team therefore recommends combination therapy as a preferable option for treating AR.9 

Various studies have examined the safety and effectiveness of combination azelastine/fluticasone nasal spray in different scenarios. Ratner et al demonstrated that this combination significantly improved TNSS by 37.9%. Similarly, Hampel et al found that it enhanced TNSS, improving nasal congestion, runny nose, itchy nose, and sneezing, by 28.4%.10,11 

In a recent systematic review and meta-analysis by Debbaneh et al, the combination azelastine/fluticasone nasal spray was found to outperform placebo in reducing TNSS by 60%. The authors of this study concluded that the existing evidence strongly supports the efficacy and superiority of combination azelastine/fluticasone in alleviating symptom scores reported by patients with allergic rhinitis (AR). Consequently, they advocate for considering combination nasal spray as a second-line therapy for patients whose AR symptoms are not adequately managed with monotherapy.12 

Conclusion 

Viatris' introduction of the FDC azelastine/fluticasone nasal spray marks a significant milestone in the management of paediatric AR in South Africa. Research findings demonstrate an impressive 95.2% improvement in TNNS scores compared to monotherapy. As AR profoundly impacts paediatric patients' and their caregivers' QoL, combination therapy offers hope for substantial relief.  

References 

  1. Professional information.  Dymista Nasal Spray. 2024. [Internet]. Available at: https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2024/03/pil_dymista_approved_oct2023.pdf 
  2. Wise SK, Lin SY, Toskala E, et al. International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis. Int Forum Allergy Rhinol, 2018. 
  3. Bosnic-Anticevich S, Smith P, Abramson M, et al. Impact of allergic rhinitis on the day-to-day lives of children: insights from an Australian cross-sectional study. BMJ Open, 2020. 
  4. Dykewicz MS, Wallace DV, Amrol DJ, et al. Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol, 2020 
  5. McDonald M, de Waal PJ. Allergic Rhinitis in Children: Comparing South African Recommendations and European Guidelines. Current Allergy & Clinical Immunology, 2022.  
  6. Blaiss MS, Hammerby E, Robinson S, et al. The burden of allergic rhinitis and allergic rhinoconjunctivitis on adolescents: a literature review. Ann Allergy Asthma Immunol, 2018. 
  7.  Meltzer EO, Gross GN, Katial R, et al. Allergic rhinitis substantially impacts patient quality of life: findings from the nasal allergy survey assessing limitations. J Fam Pract, 2012. 
  8. Kaya Akca Ü, Maslak İC, Uygun D, Bingöl A. The Asthma Risk Is Increased in Children with Severe Allergic Rhinitis. Turk Arch Pediatr, 2022. 
  9. Li J, Shen Y, Zou QY. Efficacy and safety of monotherapy versus combination therapy in treatment of allergic rhinitis: a meta-analysis. Journal of Clinical Otorhinolaryngology, Head, and Neck Surgery, 2019. 
  10. Ratner PH, Hampel F, Van Bavel J, et al. Combination therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol, 2008. 
  11. Hampel FC, Ratner PH, Van Bavel J, et al. Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol, 2010.  
  12. Debbaneh PM, Bareiss AK, Wise SK, et al. Intranasal Azelastine and Fluticasone as Combination Therapy for Allergic Rhinitis: Systematic Review and Meta-analysis. Otolaryngology-Head and Neck Surgery, 2019. 

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