Real‐world evidence for the long‐term effect of allergen immunotherapy: Current status on database‐derived European studies

Abstract

Randomized controlled trials (RCTs) are the gold‐standard for benefit–risk assessments during drug approval processes. Real‐word data (RWD) and the resulting real‐world evidence (RWE) are becoming increasingly important for assessing the effectiveness of drug products after marketing authorization showing how RCT results are transferred into real life care. The effectiveness of allergen immunotherapy (AIT) has been assessed in several RWE studies based on large prescription databases. We performed a literature search for retrospective cohort assessments of prescription databases in Europe to provide an overview on the methodology, long‐term effectiveness outcomes, and adherence to AIT. Thirteen respective publications were selected. AIT was more effective in reducing the progression of allergic rhinitis (AR) compared to a non‐AIT control group receiving only symptomatic treatment for AR for up to 6 years. The development and progression of asthma were hampered for most endpoints in patients treated with most preparations compared to the non‐AIT group, receiving only anti‐asthmatic medication. The results for “time to onset” of asthma were inconsistent. Adherence to AIT decreased during the recommended 3‐year treatment period, however, in most studies higher adherence to subcutaneous than to sublingual AIT was shown. The analysis of long‐term effectiveness outcomes of the RWE studies based on prescription databases confirms the long‐term efficacy of AIT demonstrated in RCTs. Progression of rhinitis and asthma symptoms as well as delayed onset of asthma triggered by different allergens, real life adherence to the treatment shows differences in particular application routes.

Oral Azvudine for hospitalised patients with COVID-19 and pre-existing conditions: a retrospective cohort study

“…Real-world research evidence is increasingly important for evaluating post-marketing effectiveness of drugs, which is the practice of translating the results of randomised controlled trials into real-world clinical applications. 23 Patients enrolled in randomised controlled trials are highly selected with a variety of demanding conditions, for which are not comparable to more heterogeneous populations in clinical practice. 24 Our real-world research included a number of patients with variable treatment patterns and various alternative interventions in practice, which could better reflect the real efficacy of Azvudine for the management of hospitalised patients with COVID-19 and pre-existing conditions.…”

Hot topics in allergen immunotherapy, 2023: Current status and future perspective

“…RCTs have shown that AIT is effective in reducing allergy symptoms, and RWD-based studies have provided evidence that these benefits can extend to the long term and in diverse patient groups. [105][106][107][108] Additionally, in patients with concurrent asthma, AIT was associated with a reduced likelihood of asthma exacerbations and pneumonia. 109 RWD of persistence and adherence rates showed for SCIT and SLIT significant variability depending on the study methodology and duration of follow-up.…”

Immunomodulatory properties of mesenchymal stem cells: A potential therapeutic strategy for allergic rhinitis

“…[63][64][65] SCIT and SLIT have been proven to effectively reduce symptoms and medication use and modify disease pathology, leading to a long-term curative effect after stopping treatment. [66][67][68] AIT relies on the modifying effect on innate and adaptive immune responses associated with type 2 inflammation. 69,70 The effects of AIT on innate responses include reducing the local infiltration of mast cells, basophils, and eosinophils; decreasing circulating frequencies of ILC2; elevating complement C1Q-expressing regulatory DCs; and restoring epithelial cell integrity.…”

“…AIT can be applied subcutaneously (SCIT) or sublingually (SLIT) and is suitable for children and adults for a variety of allergens, including pollen, cat, dog, house dust mite, and venom 63–65 . SCIT and SLIT have been proven to effectively reduce symptoms and medication use and modify disease pathology, leading to a long‐term curative effect after stopping treatment 66–68 . AIT relies on the modifying effect on innate and adaptive immune responses associated with type 2 inflammation 69,70 .…”