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Positive Results of EfficAPSI Real-World Study Confirm Significant Benefit of Sublingual Liquid AIT Treatment on the Onset and Worsening of Asthma in Patients With Allergic Rhinitis


Stallergenes Greer, a global healthcare company specialising 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 significant benefit of sublingual liquid allergen immunotherapy treatment (AIT) on the onset and worsening of asthma in patients with allergic rhinitis.

The retrospective longitudinal pharmaco-epidemiological real-world study included over 430,000 patients: more than 100,000 patients with allergic rhinitis with or without asthma treated with sublingual liquid immunotherapy and symptomatic drugs; compared to more than 330,000 patients with allergic rhinitis with or without asthma treated with symptomatic drugs only.

The primary objective of the study was the evaluation of 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 above age of 5), allergens and endpoints, and showed:

"The results of the EfficAPSI real-world study confirm and broaden the findings of randomised clinical trials and strengthen the body of evidence of the positive impact of sublingual liquid AIT on the 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 patients with allergies," said 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 datasets, which allow us to assess additional aspects of AIT treatment, are critical to improving care for patients with allergies. Stallergenes Greer initiated and contributed to the development of real-world evidence in the field of allergy; these data allow us to deepen our knowledge and understanding of patient outcomes in real life, while providing substantial information on increasingly common allergens. This landmark study further demonstrates the positive impact of Stallergenes Greer's sublingual allergen immunotherapy treatments on public health," declared Michele Antonelli, Chief Executive Officer, Stallergenes Greer.

Analysis of the results regarding the secondary objective of the EfficAPSI study is underway.

ABOUT EfficAPSI

EfficAPSI is the largest retrospective real-world, longitudinal cohort study regarding sublingual liquid allergen immunotherapy treatment. Its objective is to evaluate 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 drugs and more than 330,000 patients with allergic rhinitis with or without asthma treated with symptomatic drugs only.

EfficAPSI is the first study in the AIT field in which the French national system database (SNDS), covering 99% of the French population, has been used to gain insight on therapeutic benefits in real life practice by pairing their data with the data of a healthcare company.

Onset or worsening of asthma were defined as the first occurrence of a specific pharmacy dispensation, hospital discharge summaries or long-term diseases or asthma in the main analysis; pharmacy dispensation was omitted for a more specific, secondary definition, focusing on severe forms of asthma. Analyses were stratified on pre-existing mild or moderate asthma to differentiate between the onset and worsening of asthma.

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

Onset of asthma data: among allergic rhinitis patients without pre-existing asthma, sublingual liquid AIT was associated with a significantly lower risk of occurrence of asthma when compared to control group (symptomatic drugs only), according to main (HR: 0.78, 95% CI 0.77-0.79) and secondary definition (HR: 0.80, 95% CI 0.73-0.87).

Worsening of asthma data: among allergic rhinitis patients with pre-existing asthma, sublingual liquid AIT was associated with a significantly lower risk of worsening of asthma when compared to control group (symptomatic drugs only), according to main (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 house dust mites, grass, birch, ragweed pollens, and cat. Results are positive and consistent for all allergens and all age groups.

The study was designed with a scientific committee composed by Prof. Pascal Demoly, MD, PhD, HDR, Head of the Pulmonology, Allergology and Thoracic Oncology Department, Montpellier University Hospital (France); Prof. Philippe Devillier, Hôpital Foch, Paris (France); Dr. Jean François Bergman, Head of Internal Medicine, Hôpital Lariboisière, 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 worldwide disease affecting more than 500 million people, who are at higher risk of developing rhinitis exacerbation and asthma than the general population. Allergic rhinitis can include symptoms such as sneezing, a runny or itchy nose, nasal congestion and watery or itchy eyes, among othersi, ii. Symptoms may 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

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

_________________________
i Demoly P, Corren J, Creticos P, et al. A 300 IR sublingual tablet is an effective, safe treatment for house dust mite?induced allergic rhinitis: An international, double-blind, placebo- controlled, randomized 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. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines? 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 J-W, Sue J-H, Song T-W, et al. Atopy and house dust mite sensitization as risk factors for asthma in children. Yonsei Med J.2005;46: 629- 634.
vi Hankin C. S., 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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