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

BAAR, Switzerland –



Stallergenes Greer, a global healthcare company specializing in allergen immunotherapy (AIT), today announced positive real-world data from its EfficAPSI study. The real-world study presented at the 2022 Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Prague (Czech Republic) confirmed a significant benefit of sublingual liquid allergen immunotherapy (AIT) in relation to the development and worsening of asthma in patients with allergic rhinitis.

The retrospective longitudinal pharmacoepidemiological study included more than 430,000 patients: we compared more than 100,000 patients with allergic rhinitis with or without asthma treated with sublingual liquid immunotherapy and symptomatic drugs and with more than 330,000 patients with allergic rhinitis with or without asthma treated only with symptomatic medications.

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

  • a greater than 20% reduction in the risk of developing asthma in patients treated with liquid sublingual AIT and symptomatic medications compared to patients treated with symptomatic medications alone;

  • a 28% reduction in the risk of worsening asthma and up to 37% in severe forms.

“The results of the EfficAPSI study in the real world confirm and complement the results of randomized clinical trials and reinforce the evidence of the positive effects of the sublingual. liquid AIT on the development and worsening of allergic asthma in patients with allergic rhinitis. They show the relevance of etiological treatment and support the efficacy of AIT in patients with allergies. “says Professor Dr. Pascal Demoly, MD, PhD, HDR, Director of the Department of Pulmonology, Allergology and Thoracic Oncology at the University Hospital of Montpellier (France) and member of the scientific committee of the study.

“Large and robust real-world datasets that allow us to evaluate additional aspects of AIT treatment are critical to improving the care of patients with allergies. Stallergenes Greer initiated and supported the development of real-world trials in the field of allergies. These findings help us deepen our knowledge and understanding of patient outcomes in the field, while providing substantial data on increasingly common allergens. This landmark study further demonstrates the positive impact of Stallergenes Greer’s sublingual allergen immunotherapy on healthcare. “explains Michele Antonelli, managing director of Stallergenes Greer.

The analysis of the results with respect to the secondary objective of the EfficAPSI study is in progress.

ON EfficAPSI

EfficAPSI is the largest retrospective, practice-oriented, longitudinal cohort study of liquid allergen sublingual immunotherapy. The aim of the study is to investigate the effects of liquid allergen sublingual immunotherapy on the development 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 exclusively with symptomatic medications.

EfficAPSI is the first AIT study to use the French National System Database (SNDS), containing data covering 99% of the French population, to generate insights into therapeutic benefits by practically merging this data with data from a healthcare company become.

The onset and worsening of asthma were defined in the main analysis as first administration of a particular drug, hospital discharge reports, or long-term illness or asthma. For a more specific and secondary definition focused on severe forms of asthma, the administration of drugs was excluded. Analyzes were stratified by pre-existing mild or moderate asthma to differentiate between onset and worsening of asthma.

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

Developmental asthma data: In patients with allergic rhinitis without pre-existing asthma, liquid sublingual AIT was associated with a significantly lower risk of developing asthma than in the control group (symptomatic drugs only), depending on the principal ( HR: 0.78, 95% CI 0.77-0.79) and secondary definition (HR: 0.80, 95% CI 0.73-0.87).

Data on worsening of asthma: In patients with allergic rhinitis and pre-existing asthma, sublingual liquid AIT was associated with a significantly lower risk of worsening asthma than in the control group (symptomatic drugs only), depending on the principal (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 broad spectrum of allergens, including house dust mites, grass, birch and ragweed pollen, and cats. The results are positive and consistent for all allergens and all age groups.

The study was designed by a scientific committee which included the following members: Prof. Dr. Pascal Demoly, MD, PhD, HDR, Director of the Department of Pneumology, Allergology and Thoracic Oncology at the University Hospital of Montpellier (France), Prof . Philippe Devillier, Hôpital Foch, Paris (France), Dr. Jean François Bergman, Director of Internal Medicine, Hôpital Lariboisière, Paris, Professor of Therapy, University Paris-Diderot (France), Dr. Bertrand Delaisi, Paris (France), and Dr. Mathieu Molimard, Bordeaux (France).

ON ALLERGIC RHINITIS

More than 500 million people worldwide suffer from allergic rhinitis. They are at a higher risk than the general population of developing exacerbation of rhinitis and asthma. Symptoms of allergic rhinitis can include sneezing, runny or itchy nose, nasal congestion, and watery or itchy eyes. I, ii. Symptoms can be severe, worsen over time, and significantly affect quality of life1, iii, iv, v, vi.

ABOUT STALLERGENES GREER INTERNATIONAL AG

Stallergenes Greer International AG, based in Baar (Switzerland), is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and marketing 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). Visit www.stallergenesgreer.com for more information.

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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: an international, double-blind, randomized, phase III, placebo-controlled clinical trial. J Allergy Clin Immunol. 2021

ii Bousquet J, Khaltaev N, Cruz A, et al. Allergic rhinitis and its impact on asthma (ARIA) Update 2008 (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 for allergic rhinitis and its impact on asthma (ARIA): 2016 review. 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 study. The Copenhagen Allergy Study. Allergy. 2002 Nov; 57 (11): 1048-1052.

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

you Hankin CS, Cox L., Lang D., et al. Allergen immunotherapy and health 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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Those: Business Wire

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