Allergy | 2021
Effects of allergen immunotherapy in the MASK‐air study: a proof‐of‐concept analysis
Abstract
To the Editor, Allergen immunotherapy (AIT) is effective in allergic rhinitis (AR) and/or asthma. Randomized controlled trials (RCTs) have demonstrated the efficacy and safety of both subcutaneous (SCIT) and sublingual (SLIT) immunotherapy in patients allergic to pollen and house dust mites.1 RCTs are mandatory for market authorization of AIT products but they lack realworld data (RWD). Many AIT guidelines have been formulated but they have not imputed RWD. Observational studies with RWD complement RCTs and provide novel information on AIT in real life. The European Academy of Allergy and Clinical Immunology (EAACI) emphasized the value of RWD data in AIT.2 This proofofconcept (POC) study aimed to assess the effects of AIT in AR using RWD obtained with a validated app (MASKair®), a Good Practice of DG Santé.3,4 All MASKair® data from 21 May 2015 to 6 December 2020 in 25 countries have been analysed. MASKair® comprises a daily questionnaire in which users are asked to answer six questions assessing AR symptoms visual analogue scales (VASs) and provide information on AIT and medication. Days of participants using AIT use were compared to days from nonAIT participants using (i) daily global symptoms VAS (how much allergy symptoms were bothering the user) and ii) work VAS (impact of allergic symptoms on work). Separate analyses were performed for (i) days when no medication, (ii) days with monotherapy (single drug formulation), and (iii) days with comedication (more than one drug formulation) were used. Sensitivity analyses were performed with the AIT group comprising data from users under AIT irrespective of the days when AIT was effectively done. Continuous variables are presented as medians (with 95% confidence intervals [CI]) and interquartile ranges (IQR). Median VAS values were compared using the MannWhitney U test. 317,176 days of MASKair® (17,870 users) were analysed, of which 138,304 (43.6%) involved the reporting of medication(s) and 36,229 (11.4%) of AIT. We observed a global symptoms median VAS of 9 (95%CI=[9– 9]) for days of users treated by AIT versus 12 (95%CI=[12– 12], p<0.001) for days of nonAIT users (Table 1). The AIT median global symptoms VASs were lower when considering (i) days under no medication (7