Positive results from the real-world EfficAPSI study confirm the significant benefits of sublingual liquid AIT treatment on the onset and worsening of asthma in patients with allergic rhinitis

BAAR, Switzerland–(BUSINESS WIRE)–Stallergenes Greer, a global healthcare company specializing in allergen immunotherapy (AIT), today announced positive data from its EfficAPSI real-world study. Presented at the 2022 European Academy of Allergy and Clinical Immunology (EAACI) Congress in Prague, Czech Republic, the real-world study confirmed the significant benefit of sublingual liquid allergen immunotherapy (AIT) treatment on onset and worsening of asthma in patients with allergies. rhinitis.

The retrospective longitudinal pharmacoepidemiological study in real-life situations included more than 430,000 patients: more than 100,000 patients with allergic rhinitis with or without asthma treated with sublingual liquid immunotherapy and symptomatic medications; compared to more than 330,000 patients with allergic rhinitis with or without asthma treated only with symptomatic medications.

The primary objective of the study was to assess the impact of sublingual liquid AIT on the onset and worsening of asthma in patients with allergic rhinitis. Study results were consistent across all age groups (patients over 5 years of age), allergens, and endpoints, and showed:

  • a reduction in the risk of onset of asthma of more than 20% observed in patients under treatment with sublingual liquid AIT and symptomatic medications versus patients treated with symptomatic medications alone;

  • a reduction in the risk of aggravation of asthma by 28% and reaching 37% for severe forms.

The results of the real-world EfficAPSI study confirm and extend the results of randomized clinical trials and reinforce the body of evidence of the positive impact of sublingual liquid AIT on onset and worsening of allergic asthma in patients with allergic rhinitis. They highlight the relevance of etiological treatment while further demonstrating the efficacy of AIT on allergic patientssaid Professor Pascal Demoly, MD, PhD, HDR, head of the pulmonology, allergology and thoracic oncology department, Montpellier University Hospital (France) and member of the study’s scientific committee.

“Large, robust, real-world data sets, which allow us to evaluate additional aspects of AIT treatment, are essential to improving the care of allergy patients. Stallergenes Greer initiated and contributed to the development of concrete evidence in the field of allergy; this data allows us to deepen our knowledge and understanding of real-life patient outcomes, while providing substantial insight into increasingly common allergens. This landmark study demonstrates once again the positive impact of Stallergenes Greer’s sublingual allergen immunotherapy treatments on public health. said Michele Antonelli, Managing Director of Stallergenes Greer.

The analysis of the results concerning the secondary objective of the EfficAPSI study is in progress.

ABOUT EfficAPSI

EfficAPSI is the largest real-world retrospective longitudinal cohort study of sublingual liquid allergen immunotherapy treatment. Its objective is to assess the real-life impact of sublingual liquid allergen immunotherapy on the onset and worsening of asthma in patients with allergic rhinitis. This study included more than 100,000 patients in France with allergic rhinitis with or without asthma treated with sublingual liquid AIT and symptomatic medications and more than 330,000 patients with allergic rhinitis with or without asthma treated only with symptomatic medications.

EfficAPSI is the first study in the field of AIT in which the database of the French national system (SNDS), covering 99% of the French population, was used to understand the therapeutic benefits in real practice by matching their data with the data of a healthcare company.

New onset or worsening of asthma was defined as the first occurrence of a specific pharmaceutical dispensation, hospital discharge summaries, or long-term illness or asthma in the primary analysis; pharmaceutical dispensing has been omitted for a more precise secondary definition, focusing on severe forms of asthma. Analyzes were stratified by pre-existing mild or moderate asthma to differentiate between onset and worsening asthma.

A total of 101,345 exposed patients (sublingual liquid AIT) and 333,082 unexposed patients (control) were included.

Asthma onset data: In patients with allergic rhinitis without pre-existing asthma, sublingual liquid AIT was associated with a significantly lower risk of onset of asthma compared to the control group (symptomatic medications only), according to primary (HR: 0.78, 95% CI 0.77-0.79) and secondary definition (HR: 0.80, 95% CI 0.73-0.87).

Worsening asthma data: In allergic rhinitis patients with pre-existing asthma, sublingual liquid AIT was associated with a significantly lower risk of worsening asthma compared to the control group (symptomatic medications only) , according to primary (HR: 0.72, 95% CI 0.71-0.73) and secondary definition (HR: 0.63, 95% CI 0.59-0.66).

The EfficAPSI study covers a wide range of allergens, including dust mites, grass, birch, ragweed and cat pollens. Results are positive and consistent across all allergens and age groups.

The study was designed with a scientific committee made up of Pr Pascal Demoly, MD, PhD, HDR, Head of the Department of Pneumology, Allergology and Thoracic Oncology, Montpellier University Hospital (France); Prof. Philippe Devillier, Foch Hospital, Paris (France); Dr Jean François Bergman, Head of Internal Medicine, Lariboisière Hospital, Paris, Professor of Therapeutics, Paris-Diderot University (France). Dr Bertrand Delaisi, Paris (France), and Dr Mathieu Molimard, Bordeaux (France).

ABOUT ALLERGIC RHINITIS

Allergic rhinitis is a global disease that affects more than 500 million people, who are at a higher risk of developing an exacerbation of rhinitis and asthma than the general population. Allergic rhinitis can include symptoms such as sneezing, runny or itchy nose, nasal congestion, and watery or itchy eyes, among othersI, ii. Symptoms can be severe and can worsen over time and have a significant impact on quality of life1, iii, iv, v, vi.

ABOUT STALLERGENES GREER INTERNATIONAL AG

Based in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (headquartered in the United States) and Stallergenes SAS (headquartered in France). For more information, visit www.stallergenesgreer.com.

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I Demoly P, Corren J, Creticos P, et al. A 300 IR sublingual tablet is an effective and safe treatment for house dust mite-induced allergic rhinitis: a randomized, double-blind, placebo-controlled international phase III clinical trial. J Allergy Clin Immunol. 2021

ii Bousquet J, Khaltaev N, Cruz A, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160.

iii Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, et al. Guidelines on allergic rhinitis and its impact on asthma (ARIA) – 2016 revision. J Allergy Clin Immunol. 2017;140(4):950–8

iv Linneberg A, Henrik Nielsen N, Frolund L, et al. The link between allergic rhinitis and allergic asthma: a prospective population-based study. The Copenhagen Allergy Study. Allergy. 2002 Nov;57(11):1048-1052.

v Shin JW, Sue JH, Song TW, et al. Atopy and dust mite sensitization as risk factors for asthma in children. Yonsei Med J.2005;46:629-634.

vi Hankin CS, Cox L, Lang D, et al. Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale retrospective matched cohort study. Ann Allergy Asthma Immunol. 2010 Jan;104(1):79-85

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