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Review
. 2022 Dec;77(12):3584-3592.
doi: 10.1111/all.15506. Epub 2022 Sep 19.

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

Christian Vogelberg  1 , Ludger Klimek  2 , Bernd Brüggenjürgen  3 , Marek Jutel  4   5
Affiliations
Review

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

Christian Vogelberg et al. Allergy. 2022 Dec.

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.

Keywords: allergen immunotherapy; allergic asthma; allergic rhinitis; long-term efficacy; real-world evidence.

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Conflict of interest statement

Christian Vogelberg reports consulting fees and/or payment or honoraria for lectures, presentations, or speakers bureaus from Allergy Therapeutics, Bencard Allergie, Allergopharma, HAL Allergy, Stallergenes Greer, Novartis Pharma, LETI Pharma, DBV Technology, Aimmune, Sanofi Aventis, ALK‐Abelló, Memberships: AeDA, GPA, APPA, DGAKI, EAACI. Ludger Klimek reports grants, institutional fees, and/or institutional payment for expert testimony from Allergopharma, Viatris, Stallergenes Greer, GSK, Sanofi, Leti Pharma, HAL Allergy, ALK‐Abelló, Quintiles, ASIT biotech, Lofarma, AstraZeneca, Inmunotek, Allergy Therapeutics, Cassella med, Novartis, Regeneron Pharmaceuticals, Roxall Medizin GmbH; Memberships: AeDA, DGHNO, Deutsche Akademie für Allergologie and klinische Immunologie, HNO‐BV, GPA, EAACI. Bernd Brüggenjürgen reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Allergopharma and IQVIA, outside the submitted work. Marek Jutel reports consulting fees and/or payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Allergopharma, Stallergenes Greer, ALK Abelló, Chiesi, HAL Allergy, GSK; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: EAACI, Fundacja Centrum Walki z Alergia.

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