Stallergenes Greer Publishes in the Lancet Regional Health-Europe Landmark EfficAPSI Real-world Study Confirming Significant Benefit of Its Liquid Sublingual AIT on the Onset and Progression of Allergic Asthma

Stallergenes Greer, a global healthcare company specialising in allergen immunotherapy (AIT), today announced that results of its EfficAPSI real-world study evaluating the impact of Stallergenes Greer liquid sublingual AIT (SLIT-liquid) on asthma onset and evolution in patients with allergic rhinitis have been published in the Lancet Regional Health-Europe. The publication is available online (https://doi.org/10.1016/j.lanepe.2024.100915) and will be available in print at a later date.

This retrospective longitudinal pharmaco-epidemiological real-world study, which evaluated data over a 9-year period, included over 440,000 patients: more than 110,000 patients with allergic rhinitis, with or without asthma, treated with Stallergenes Greer SLIT-liquid 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 real-world impact of Stallergenes Greer SLIT-liquid on the prevention of asthma onset or worsening in patients with allergic rhinitis. Study results were consistent across all age groups (patients above the age of 5), allergens and endpoints.

In patients undergoing treatment with Stallergenes Greer SLIT-liquid and symptomatic drugs versus patients treated with symptomatic drugs only, the study showed:

• a 36% reduction in the risk of new asthma events in the overall cohort*;
• a 38% reduction in the risk of asthma onset in patients without pre-existing asthma;
• a one-third reduction in Global Initiative for Asthma (GINA) treatment stepping-up, in patients with pre-existing asthma demonstrating the impact of SLIT-liquid to prevent asthma worsening.

“I am pleased that the publication of this extensive, large real-world EfficAPSI study in the Lancet Regional Health-Europe is now available for the medical community. The study confirms the role of SLIT- liquid in reshaping asthma management. The findings deliver important insights on the relevance of SLIT liquid as etiological medication which offers the advantage of a personalised treatment tailored to each patient's unique needs for improved outcomes,” said Professor Pascal Demoly, MD, PhD, Head of the Pulmonology, Allergology and Thoracic Oncology Department, Montpellier University Hospital (France), President of the French Society of Allergology, and member of the study’s scientific committee.

“ Exploring the impact of allergen immunotherapy on asthma onset and progression is crucial, and we're committed to filling those gaps. Through this real-world EfficAPSI study, Stallergenes Greer is honoured to contribute valuable scientific evidence and insights to allergy treatment. We remain focused on advancing disease-modifying solutions, fuelled by strong clinical data, to redefine respiratory care, and dedicated to improving quality of life for people with allergies” declared Dr Elena Rizova, Chief Medical Officer, Stallergenes Greer.

By demonstrating the benefit on the onset and worsening of asthma, Stallergenes Greer SLIT-liquid treatments confirm their impact in terms of public health. Stallergenes Greer intends to increasingly use a real-world approach to bolster the evidence supporting the beneficial effects of SLIT. Additional endpoints are currently under evaluation and will be published subsequently.

ABOUT EfficAPSI ¹

EfficAPSI is to date the largest retrospective real-world, longitudinal cohort study regarding liquid sublingual AIT. Its main objective was to evaluate the real-life impact of SLIT-liquid on the prevention of asthma onset and worsening in patients with allergic rhinitis. This study included more than 110,000 patients in France with allergic rhinitis, with or without asthma, treated with Stallergenes Greer SLIT-liquid and symptomatic drugs and more than 330,000 patients with allergic rhinitis, with or without asthma, treated with symptomatic drugs only. The EfficAPSI study, evaluated data from January 1, 2010 to December 31, 2018.

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, hospitalisation or long-term disease (LTD) for asthma in the sensitive analysis; pharmacy dispensation was omitted for a more specific, secondary definition, focusing on severe forms of asthma. A combined definition, both sensitive and specific, was also used considering specific pharmacy dispensation of major medications (omalizumab or three inhaled corticosteroids associated or not with long-acting beta agonists), hospitalisation or LTD for severe asthma. Analyses were stratified on pre-existing mild or moderate asthma to differentiate between the onset and worsening of asthma.

A total of 112,492 exposed (SLIT-liquid) and 333,082 unexposed patients (control) were included.

Findings on new asthma events: in allergic rhinitis patients, Stallergenes Greer SLIT-Liquid exposure was associated with a significantly lower risk of new asthma events, when compared to control group (symptomatic drugs only), according to all definitions (sensitive, HR: 0.76, 95% CI 0.75-0.76; specific, HR: 0.66, 95% CI 0.63-0.69; combined, HR: 0.64, 95% CI 0.63-0.65).

Findings on onset of asthma: in allergic rhinitis patients without pre-existing asthma, Stallergenes Greer SLIT-liquid exposure was associated with a significantly lower risk of asthma onset when compared to control group (symptomatic drugs only), according to all definitions (sensitive, HR: 0.77, 95% CI 0.76-0.78; specific, HR: 0.67, 95% CI 0.61-0.72; combined, HR: 0.62, 95% CI 0.60-0.63).

Findings on worsening of asthma: in allergic rhinitis patients with pre-existing asthma, Stallergenes Greer SLIT-liquid exposure was associated with a significantly lower risk of asthma events when compared to control group (symptomatic drugs only), according to all definitions (sensitive, HR: 0.71, 95% CI 0.70-0.72; specific, HR: 0.62, 95% CI 0.59-0.65; combined, HR: 0.62, 95% CI 0.61-0.63). In addition, a one-third reduction in GINA treatment stepping-up was observed regardless of patients’ GINA treatment step at baseline (HR: 0.72, 95% CI 0.69-0.75 for baseline step 1; HR: 0.73, 95% CI 0.68-0.79 for baseline step 2; HR; 0.71, 95% CI 0·65-0·78 for baseline step 3/4).

The EfficAPSI study covers a wide range of allergens including house dust mites, grass, birch and ragweed pollens, and cat dander. Results were positive and consistent for all analysable allergens and all age groups (above the age of 5).

The study was designed with a scientific committee composed of Prof. Pascal Demoly, MD, PhD, HDR, Head of the Pulmonology, Allergology and Thoracic Oncology Department, Montpellier University Hospital (France); Prof. Philippe Devillier, Hôpital Foch, Suresnes (France); Prof. Jean François Bergmann, Head of Internal Medicine, Hôpital Lariboisière, Paris, Professor of Therapeutics, Paris-Diderot University (France); Dr. Bertrand Delaisi, Boulogne-Billancourt (France), and Prof. Mathieu Molimard, Head of the Pharmacology Department, Bordeaux University Hospital (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 others.^2,3 Symptoms may be severe and can worsen over time and have a significant impact on quality of life.^2,4,5,6,7

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 respiratory, food and venom 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.

*combined score

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1} Demoly P, Molimard M, Bergmann JF, et al. Impact of liquid sublingual immunotherapy on asthma onset and progression in patients with allergic rhinitis: a nationwide population-based study (EfficAPSI study). Lancet Reg Health Eur. 2024. https://doi.org/10.1016/j.lanepe.2024.100915
² 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;147(3):1020-1030.e10
³ 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.
⁴ 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
⁵ 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.
⁶ 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.
⁷ 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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Catherine Kress
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Email: catherine.kress@stallergenesgreer.com