Stallergenes Greer plc: Two New Real-World Evidence Studies Show Long-Term Benefits of Sublingual Allergy Immunotherapy
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, announced positive results from two real-world evidence studies regarding the use of allergy immunotherapy (AIT) compared to the use of only symptomatic treatments to treat patients with respiratory allergies. These studies were retrospective longitudinal analyses of French and German prescription databases and further substantiated the long-term benefits of AIT to significantly reduce the need for allergic rhinitis and asthma medication in patients suffering from grass pollen- and birch tree pollen-induced allergies. These studies are part of the BREATH real-world evidence program, which is designed to understand the real-world benefits of allergy immunotherapy outside of a clinical trial setting.
“As a global leader in allergy immunotherapy, we are pleased to be able to provide further evidence into the real-world effectiveness of allergy immunotherapy for patients across Europe,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “The BREATH program has allowed us to deepen our knowledge and understanding of real-life patient outcomes. We look forward to bringing these outcomes to international forums to provide further evidence on the benefits that AIT can offer to a broader range of patients suffering from respiratory allergies. Today, less than 1% of patients are treated with allergy immunotherapy.1”
Grass pollen tablets demonstrate effectiveness in reducing allergic rhinitis and asthma medication intake for allergic rhinitis patients in France 6,7,8
This retrospective analysis is based on four years’ worth of prescription data from 28,574 patients in France and demonstrated the statistically significant long-term benefit of grass pollen AIT sublingual tablets, including Stallergenes Greer’s Oralair®, on grass pollen-induced allergic rhinitis compared to only symptomatic treatments. The study included 1,099 patients treated with AIT sublingual tablets as well as symptomatic medications, and a non-AIT control group of 27,475 patients receiving only symptomatic medications. Study results showed that the number of symptomatic medication prescriptions per patient per year decreased by 50 percent in the post-treatment follow-up in the AIT group, compared to an increase of prescriptions (30 percent) for patients in the non-AIT group who were using only symptomatic treatments. In addition, the risk of new asthma medication onset in the AIT group during the follow-up period was 63 percent lower when compared to the non-AIT group (p=0.0025). Among patients who were already taking asthma medications at the onset of the study, AIT was associated with a 40 percent decrease in asthma medication prescriptions during post-treatment follow-up versus baseline, compared to a 20 percent increase of asthma medication prescriptions among the non-AIT group.
“The results from this study are significant and further demonstrate the positive impact allergy immunotherapy can bring to allergic patients,” said Professor Pascal Demoly, from Montpellier University’s Pneumology and Addiction Department and a member of the study’s scientific committee. “First, there is a clear benefit to AIT, showing that AIT reduced symptomatic medication prescriptions where patients who received only symptomatic treatments saw their need for medication increase. Second, these results are consistent with those obtained in Germany, confirming the scientific solidity of the methodology and suggesting transferability to other countries.”
Birch tree AIT demonstrates effectiveness in reducing allergic rhinitis and asthma medication intake for allergic patients in Germany 9,10,11
The retrospective analysis based on eight years’ worth of prescription data from 54,006 patients in Germany demonstrated the statistically significant long-term benefit of birch tree pollen AIT treatments, including Stallergenes Greer’s Staloral® sublingual drops, on birch tree-induced allergic rhinitis and asthma compared to only symptomatic treatments. The study included 9,001 patients treated with AIT (administered as either a sublingual or subcutaneous formulation) as well as symptomatic treatments, and a non-AIT control group of 45,005 patients receiving only symptomatic treatments. During the follow-up period, significantly more patients in the AIT group (65 percent) were free of allergic rhinitis symptomatic medications compared to the non-AIT group (47 percent). In addition, during the follow-up period, 49 percent of AIT patients using asthma therapy at baseline were asthma medication free compared to 35 percent of non-AIT patients. Finally, during treatment, new onset of asthma medication was significantly reduced in the AIT group compared to the non-AIT group (p=0.001)
“This data provides new insight on allergy immunotherapy benefits for asthmatic patients,” said Professor Ulrich Wahn, Department for Pediatric Pneumology and Immunology, Charité Medical University, Berlin and a member of the study’s scientific committee. “This study builds upon our understanding of AIT and will help health care providers around the globe to make more informed decisions about how to treat patients suffering from respiratory allergies.”
Data from both studies were presented this week at the annual European Academy of Allergy and Clinical Immunology (EAACI) Congress, held in Munich, Germany. The studies are part of the BREATH real-world evidence program. The first BREATH study to be released, Zielen, et. al12, followed a similar study design and analyzed prescription data from patients with grass pollen-induced allergic rhinitis in Germany. The study was published in the peer-reviewed journal Allergy in May 2017 and its results were consistent with those released today. The three studies, funded by Stallergenes Greer, were conducted in collaboration with IQVIA (formerly Quintiles IMS), a 3rd party clinical research organization, and designed by independent scientific committees.
ABOUT BREATH
The BREATH (Bringing Real-World Evidence to Allergy Treatment for Health) real-world evidence program, sponsored by Stallergenes Greer, is designed to gather real-world data about the benefits of allergy immunotherapy (AIT). Allergy Immunotherapy is a disease-modifying treatment that treats the underlying cause of allergy and can provide long-lasting improvements of allergy symptoms. AIT can be administered sublingually (oral drop, tablet) or as an injectable formulation.
Real world data has the potential to supplement randomized controlled trial data by providing additional information about how AIT performs in routine medical practice, nevertheless, they have several limitations and cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment.
The BREATH studies reviewed prescription data for a variety of AIT products, including Stallergenes Greer’s Oralair and Staloral. Oralair is a sublingual allergy immunotherapy tablet with a mix of five grass allergen extracts (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) currently authorized in more than 30 countries around the world, including most European countries, the United States, Canada, Australia, and Russia for the treatment of grass pollen allergic rhinitis. Staloral is a sublingual immunotherapy oral drop, currently available in more than 40 countries, including most European countries for the treatment of allergy involving rhinitis, conjunctivitis, rhino-conjunctivitis or asthma (mild to moderate) of a seasonal or perennial nature, in adults and children (from the age of 5 year). Staloral is not approved in the U.S.
ABOUT STALLERGENES GREER
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).
TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market
Additional information is available at http://www.stallergenesgreer.com.
This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2017 annual report published on 30 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.
REFERENCES
1. Ozdoganoglu T, Songu M. The burden of allergic rhinitis and asthma. Ther Adv Respir Dis. 2012;6(1):11-23.
2. Simons FE. Allergic rhinobronchitis: the asthma-allergic rhinitis link. J Allergy Clin Immunol. 1999;104(3 Pt 1):534-40.
3. Greiner AN, Hellings PW, Rotiroti G, Scadding GK. Allergic rhinitis. Lancet. 2011;378:2112-22.
4. Van Bever HP, Samuel ST, Lee BW. Halting the allergic march. World Allergy Organ J. 2008;1:57-62.
5. Shaker M. New insights into the allergic march. Curr Opin Pediatr. 2014;26:516-20.
6. Devillier P., Demoly P., Ansolabehere X., Coulombel N., Molimard M., Impact of grass pollen sublingual immunotherapy tablets on allergic rhinitis and asthma: methodological aspects of a real-life, retrospective database analysis performed in France, EAACI 2018
7. Demoly P., Devillier P., Ansolabehere X., Molimard M., A real-life, long-term, retrospective analysis evidencing slower progression of grass pollen allergic rhinitis in patients treated with sublingual immunotherapy tablets, EAACI 2018
8. Demoly P., Molimard M., Ansolabehere X., Maurel F., Devillier P., A real-life, retrospective analysis evidencing slower long-term progression of asthma in grass pollen allergy patients treated with sublingual immunotherapy tablets, EAACi 2018
9. Ulrich Wahn, Claus Bachert, Joachim Heinrich, Hartmut Richter and Stefan Zielen, AIT has long-term benefits for patients with allergic rhinitis and/or asthma induced by birch family pollen: refinement of real-world study methodology designed to increase robustness of findings, EAACI 2018
10. Claus Bachert, Ulrich Wahn, Joachim Heinrich, Hartmut Richter and Stefan Zielen, Allergy immunotherapy provides long-term relief of birch family pollen-associated allergic rhinitis up to 6 years following treatment cessation: a real-world dataset analysis, EAACI 2018
11. Stefan Zielen Ulrich Wahn, Claus Bachert, Hartmut Richter and Joachim Heinrich, AIT is associated with reduced risk of asthma medication initiation and evolution up to 6 years after stopping AIT in patients with birch family pollen-induced allergic rhinitis and/or asthma, EAACI 2018
12. Zielen, S., Devillier, P., Heinrich, J., Richter, H. and Wahn, U. Sublingual immunotherapy provides long-term relief in allergic rhinitis and reduces the risk of asthma: a retrospective, real-world database analysis. Allergy. May 2017. doi:10.1111/all.13213