ALK-Abelló Inc.

Sublingual allergen immunotherapy (SLIT) is an effective disease-modifying treatment for moderate to severe allergic rhinitis, but long-term benefit depends on patients completing the recommended three-year treatment course. Real-world evidence on treatment persistence in primary care remains limited. In this prospective, non-interventional, observational study conducted in 17 Norwegian general practices included 204 patients between 6 to 65 years of age. We evaluated one-year persistence, adherence, symptom control, medication use, patient satisfaction and safety among patients treated with the grass and birch pollen SLIT-tablets Grazax and Itulazax. Overall, 78% of patients remained on treatment after one year, exceeding the predefined persistence target of 70%, while self-reported daily adherence remained above 90% throughout the follow-up. Patients reported clinically meaningful improvements in nasal, ocular, bronchial and general allergy symptoms, accompanied by reduced use of symptomatic medication and high treatment satisfaction. Adverse events were common but were predominantly mild or moderate, with no serious treatment-related safety concerns. These findings indicate that SLIT-tablet treatment can be effectively initiated and monitored in routine general practice. Persistence was comparable to that reported from specialist settings, supporting an expanding role for primary care in delivering disease-modifying treatment for allergic rhinitis. Structured follow-up within general practice may contribute to sustained treatment persistence and improve the real-world effectiveness of allergen immunotherapy.

There is a well-documented gap between the prescription of adrenaline auto-injectors (AAIs) and their real-world use during anaphylaxis. Although several aspects of AAI underuse have been investigated, the potential role of shelf life in influencing patient adherence has not been quantified. This study assessed the real-world remaining shelf life of AAIs available at pharmacies in Denmark, Finland, Sweden, and Norway, using pharmacy-level stock data and pharmacy employee-reported perceptions. Across Denmark, Finland, and Sweden, the average remaining shelf life was 9.6 months, and in Norway it was 10.5 months at the point of dispensing. In Denmark, Finland and Sweden, 100%, 91%, and 94% of employees, respectively, considered shelf life an important or very important factor when dispensing AAIs to patients. Our findings suggest that patients and caregivers filling prescriptions for AAIs frequently receive devices with limited remaining shelf life, which may necessitate multiple renewals per year. This has potential implications in terms of adherence to clinical guidelines, dependence of expired devices during emergencies, patient cost, caregiver burden, and overall societal expenditure. These results highlight an unmet need for emergency treatment options with longer shelf life to better support continuous access to life-saving medicine during anaphylaxis.

Although patients in Canada at risk of anaphylaxis are recommended to maintain access to two in-date epinephrine auto-injectors (EAIs) at all times, underuse during emergencies remains common. Multiple factors contribute to this gap, but the impact of real-world shelf life has been understudied. This study examines the remaining in-pharmacy shelf life of EAIs in Canada and considers its potential implications for patient burden, renewal frequency, and anaphylaxis preparedness. In this cross-sectional study, 50 licensed Canadian pharmacists from chain, independent, grocery/mass merchandise, and hospital pharmacies completed an online questionnaire and assessed EAI stock. Participating pharmacists verified all EAI stock on site, including batch numbers and expiry dates, and reported patient disposal practices. Of the 50 participating pharmacists, 49 reported 411 EAI devices across 98 batches. The mean in-pharmacy shelf life at dispensing was 12.8 months, with 47.4% of devices having 12 months or less remaining shelf life. Disposal practices varied and expiry was the most cited reason for disposal. Shortened in-pharmacy shelf life may increase renewal frequency, cost, waste, and the risk that patients carry expired devices or no device during anaphylaxis. Longer-shelf-life epinephrine treatment options or improved distribution chain practices may help reduce patient burden and enhance anaphylaxis preparedness in Canada.

Background Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child's quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children. Methods Phase III, randomised, double-blind, placebo-controlled trial in younger children (5-11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for similar to 1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (similar to 1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22. Findings A total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p < 0.0001) corresponding to a relative reduction of 22.0% (95% CI: 12.0, 31.1). Key secondary outcomes (DSS, DMS, TCS, PRQLQ) showed statistically significant reductions in symptoms and medication use, and improved disease-related quality of life for SQ HDM SLIT-tablet versus placebo. Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo. The SQ HDM SLIT-tablet showed a higher event rate for treatment-related adverse events (AEs) than placebo. Most events were of mild or moderate severity and few subjects discontinued due to AEs (2.5%). Interpretation The trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5-11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children.

BACKGROUND:Respiratory allergies often begin in childhood and can progress over time, leading to increased disease burden. Allergen immunotherapy (AIT) is the only causal treatment for allergic respiratory diseases with disease-modifying potential. While randomised trials support its efficacy in controlling allergic rhinitis (AR) and asthma symptoms, long-term real-world data in children remain limited. METHODS:This paediatric study (n = 11,036) was conducted within the pre-defined framework of the REACT study, based on protocol-specified objectives. Children (< 18 years) with physician-diagnosed AR, with or without pre-existing asthma, were included. AIT-treated patients were matched 1:1 to non-AIT controls. Effectiveness was assessed over 9 years by comparing AR and asthma medication prescriptions, using a public database covering all reimbursable AIT products. Relative differences were calculated across the full observation period. RESULTS:AIT-treated children (mean age 11.4 years; 62.1% male) exhibited greater reductions in AR medication use than controls (additional 9% reduction beyond 61% in controls). In children with asthma, AIT was associated with additional reductions in asthma medication use (-21% beyond -48% in controls), severe exacerbations (-21% beyond -36%), and new oral corticosteroid prescriptions (-33% beyond -41%). Age stratification revealed more pronounced AR medication reductions in younger children (0-11 years) than in adolescents (12-17 years). CONCLUSION:This large-scale, real-world study supports the long-term effectiveness of AIT in children with AR, with or without asthma. The findings reflect improved disease control and suggest a disease-modifying effect of AIT. Early intervention, particularly in younger children, may help mitigate the progression of allergic disease.