Allergen-specific immunotherapy and real-world evidence

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Abstract

Allergen immunotherapy is the most common method of treating IgE-dependent allergic disorders in clinical practice. Despite the enormous amount of data from randomized placebo-controlled trials on allergen immunotherapy efficacy, a lot of questions regarding the efficacy of allergen immunotherapy in practice remain unanswered. These questions can be answered using real-world evidence.

In conducting real-world evidence investigations of allergen immunotherapy, it is necessary to follow a strict methodology and perform a multivariate analysis of the available data. The use of statistical methods reduces the risk of bias. The REACT study, which included more than 90,000 patients with allergic rhinitis from Germany, is currently the largest and the most comprehensive real-world evidence study of allergen immunotherapy. To ensure comparable groups and representative data, a propensity score match statistical adjustment procedure was applied. The REACT study provided results of fundamental clinical and public health significance: the allergen immunotherapy leads to a sustained and long-term reduction in drug prescription in patients with allergic rhinitis and asthma, improved control of asthma, and also prevents the development of exacerbations and respiratory infections in asthma patients.

The REACT study is a good quality real-world evidence study with strict methodology and representative results.

Further high-quality standard studies of real-world data may not only confirm the randomized trial evidence but also may become a source of new evidence of the efficacy and safety of allergen immunotherapy in clinical practice.

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About the authors

Daria O. Timoshenko

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia

Author for correspondence.
Email: d.o.timoshenko@gmail.com
ORCID iD: 0000-0002-7585-1390
SPIN-code: 2714-0906

MD

Russian Federation, 24, Kashirskoe shosse, Moscow, 115522

Ksenia S. Pavlova

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia

Email: ksenimedical@gmail.com
ORCID iD: 0000-0002-4164-4094
SPIN-code: 7593-0838
Scopus Author ID: 7004658159
ResearcherId: P-9255-2017

MD, Cand. Sci. (Med.)

Russian Federation, 24, Kashirskoe shosse, Moscow, 115522

Oksana M. Kurbacheva

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia

Email: kurbacheva@gmail.com
ORCID iD: 0000-0003-3250-0694
SPIN-code: 5698-6436

MD, Dr. Sci. (Med.), Professor

Russian Federation, 24, Kashirskoe shosse, Moscow, 115522

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Supplementary files

Supplementary Files
Action
1. JATS XML
2. Fig. 1. REACT study patient selection scheme. Note: ААР ― allergic rhinitis; БА ― bronchial asthma; АСИТ ― allergen-specific immunotherapy; СПП ― comparison of predisposition indicators.

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3. Fig. 2. REACT: сhanges in the avarage prescribing/patient score over the years of follow-up relative to the pre-index year in patients with allergic rhinitis (adapted from B. Fritzsching et al. [16]). Note: АСИТ ― allergen-specific immunotherapy.

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4. Fig. 3. REACT: оdds ratio and 95% confidence interval of stepping down in asthma treatment step compared to pre-index year over follow-up years (adapted from B. Fritzsching et al. [16]). Note: АСИТ ― allergen-specific immunotherapy.

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5. Fig. 4. REACT: оdds ratio and 95% confidence interval of severe asthma exacerbation over follow-up years (adapted from B. Fritzsching et al. [16]). Note: АСИТ ― allergen-specific immunotherapy.

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6. Fig. 5. REACT: odds ratio and 95% confidence interval of pneumonia diagnosis in patients with pre-existing asthma over follow-up years (а); of inpatient hospitalizations in patients with pre-existing asthma over follow-up years (b) (adapted from B. Fritzsching et al. [16]). Note: АСИТ ― allergen-specific immunotherapy.

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