Shortened up-dosing with sublingual immunotherapy drops containing tree allergens is well tolerated and elicits dose-dependent clinical effects during the first pollen season

Abstract

Background: This study compared a rapid home-based up-dosing schedule for sublingual immunotherapy (SLIT) drops containing tree pollen allergens with two previously established schedules. Furthermore, the clinical effect of the SLIT was investigated with respect to patients' first pollen season under treatment. Methods: In this open-label, prospective, patient-preference, non-interventional study, local and systemic reactions were compared between three up-dosing groups using a SLIT formulation containing birch, alder, and hazel pollen extracts (ORALVAC ® Compact B€ aume). Clinical improvement after patients' first season under treatment was analysed using symptom scores, ARIA classification, symptom control, and the use of symptomatic medication and was compared with data from the previous, pre-treatment pollen season. As the real-life study design allowed no placebo group, the late-treated patients (co-seasonal) served as a control, and crowd-sourced symptom data from persons with hay fever were used from a free web-based online diary. Results: In 33 study centres in Germany and Austria, 164 patients were included. The treatment was well tolerated, without difference between the groups during the up-dosing phase. At the end of the assessment, 96.1% rated the tolerability of the treatment as good or very good. Local reactions were mostly mild in severity and no serious adverse events occurred. Symptom scores decreased from the 2016 pollen season to the 2017 pollen season. As for the ARIA classification, 79.0% of patients had persistent, moderate-to-severe rhinitis before treatment, but only 18.6% had the same classification after treatment. In all, 62.4% of patients achieved symptom control, and 34.3% of patients required no symptomatic medication after treatment. The rhinoconjunctivitis score was 34.4% lower for pre-seasonal treatment initiation than for the control group. Crowd-sourced symptom load indices showed that the 2016 season caused slightly more symptoms; however, it is assumed that this difference of 0.3-0.5 (score range 0-10) was of less clinical relevance.

Nondaily dosing schedule of allergen-specific sublingual immunotherapy: efficacy and safety

“…Various researchers have examined rush up-dosing schedules and have reached differing conclusions, with a few researchers finding such schedules poorer [ 23 24 ] while other experiments declare them to be non-inferior [ 25 26 ] to traditional up-dosing schedules. Mösges et al [ 1 ] compared three up-dosing schedules to examine whether the shortened up-dosing schedule might be established with similar tolerability as the previously known schedules. Mösges et al [ 1 ] found that the therapy given by using the rapid home-based up-dosing schedule was safe and well tolerated.…”

“…Mösges et al [ 1 ] compared three up-dosing schedules to examine whether the shortened up-dosing schedule might be established with similar tolerability as the previously known schedules. Mösges et al [ 1 ] found that the therapy given by using the rapid home-based up-dosing schedule was safe and well tolerated.…”

“…It offers long-term alleviation of symptoms. In addition, it may inhibit new sensitizations as well as the development of BA after AR [ 1 ].…”