Guideline on allergen immunotherapy in IgE-mediated allergic diseases

Self Cite

Introduction Allergic rhinitis (AR) is a widespread disease with increasing prevalence in developed countries. The only treatment that tackles the underlying causes is allergen immunotherapy (AIT). This treatment is performed through two application routes, the subcutaneous immunotherapy (SCIT) or the sublingual immunotherapy (SLIT). However, persistence during the long course of treatment over 3 years is key for the efficacy of this treatment option. The impaired adherence significantly impacts public health resources. The aim of this study was to assess the persistence of AIT for both application routes. Methods IQVIA TM LRx was used to identify patients starting AIT between 2009 and 2018 with grass pollen (GP), early flowering tree pollen (EFTP) and house dust mite (HDM) allergens. Patients were classified within each allergen category by AIT groups (subcutaneous depigmented polymerised allergen AIT [dSCIT], other subcutaneous AIT [oSCIT] and SLIT) and age (5‐11 years, 12‐17 years, 18+ years). Furthermore, they were followed up for up to 3 years until the cessation of treatment. Patients, who were still on treatment after 3 years were deemed to be censored. Kaplan‐Meier curves of persistence were generated and compared by log‐rank tests. Results The number of patients included in the three allergen categories was 38,717 GP, 23,183 EFTP, and 41,728 HDM AIT. In all allergen categories and for any product group, patient persistence decreased with increasing age class with the difference between 5‐11 years and 12‐17 years greater than between the latter and 18+ years. The percentage of patients completing the first year of AIT was low, particularly for SLIT where 22.2%–27.1% of patients remained persistent after 12 months. The equivalent figures for dSCIT were 52.0%–64.1% and for oSCIT 38.3%–50.3%. Conclusion Persistence in AIT in AR was low in this retrospective prescription‐based database and was clearly linked to patient age and application route.

Section: Discussionmentioning

confidence: 70%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…It is generally accepted that an early introduction to AIT is desirable for this to provide a complete and long‐lasting improvement. 6 …”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Persistence in allergen immunotherapy: A longitudinal, prescription data‐based real‐world analysis

Pfaar

Richter²,

Sager

et al. 2023

Self Cite

Barrier‐forming, drug‐free nasal spray reduces allergic symptoms induced by house dust mite allergen

Couroux

Grosse²,

Salapatek

et al. 2023

Self Cite

Background House Dust Mite (HDM) is the most common indoor allergen triggering allergic symptoms. First‐line pharmacotherapy treatment is recommended in international guidelines, while the avoidance of allergens represents a still unmet guideline principle. AM‐301 is a new non‐pharmacological nasal spray that creates a protective gel‐like barrier on the nasal mucosa, preventing the contact with the allergens. Methods This randomized, open‐label, 3‐period crossover study assessed the efficacy and safety of AM‐301. The objective was to determine whether AM‐301 reduces allergic rhinitis (AR) symptoms in patients exposed to HDM allergens. Adults with confirmed Perennial Allergic Rhinitis (PAR; n = 37) were exposed to HDM allergen in a controlled Allergen Exposure Chamber before and during a treatment course of AM‐301 (in six different sequences) within 3 weeks (A: One spray AM‐301 per nostril/B: Two sprays AM‐301 per nostril/C: no treatment). For the primary efficacy analysis, data from the total nasal symptom score (TNSS) were pooled from treatment A + B (D) and analyzed with Analysis of Covariance Model. As secondary endpoints, single time points, visits and symptoms were analyzed. Results The primary endpoint (overall change in TNSS from baseline over all three visits) showed significant results (p = 0.0085). A comparable alleviation of all four symptoms (itchy nose, nasal congestion, runny nose, sneezing) by the protective layer started to emerge after 40 min and lasted up to 180 min (end of challenge). AM‐301 resulted to be safe and well‐tolerated. Conclusion AM‐301 significantly reduced HDM‐related allergic symptoms in a standardized allergen challenge. Protection was observed to last up to 180 min.

A high‐dose, depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy has a favourable efficacy/safety ratio

Pfaar,

Sager,

Mösges

et al. 2023

Self Cite

BackgroundSubcutaneous allergen immunotherapy (SCIT) with depigmented, polymerized (DPP) birch pollen extract has been marketed at doses of up to 1000 DPP units/mL since 2001. We sought to determine the dose‐dependent efficacy of a DPP birch pollen extract formulation in patients suffering from birch‐pollen‐induced allergic rhinitis or rhinoconjunctivitis with or without intermittent asthma.MethodsA titrated conjunctival provocation test (CPT) was applied as a surrogate marker. This Phase II randomized, double‐blind, parallel‐group, dose‐ranging clinical trial was performed at 39 centres in Germany, Lithuania and Poland. After randomization to four dose‐level groups (100, 1000, 5000 and 10,000 DPP units/mL) and up‐dosing, participants received maintenance SCIT with five monthly subcutaneous injections. The primary endpoint was the proportion of patients in whom a higher concentration of birch pollen (vs. baseline) was needed to elicit a positive CPT.ResultsThree hundred forty‐three patients were included (mean (range) age: 42.6 (19–70)). The highest CPT responder rates were seen in the higher dose‐level groups. In the intention‐to‐treat analysis, the difference between the 100 and 10,000 groups was statistically significant (p = 0.0118). Although the proportion of patients with ≥1 treatment‐emergent adverse events increased with the dose, almost all these events were mild (65.6%) or moderate (18.5%).ConclusionJudging by the results of a CPT, the efficacy/safety ratio in SCIT appears to be favourable for a high‐dose‐level preparation of a DPP birch pollen extract.