The Lancet Regional Health - Europe publishes 'real-world evidence' from ALK-sponsored study confirming long-term benefits of allergy immunotherapy in allergic rhinitis and asthma

- Results from ALK-sponsored REACT (REAl-world effeCTtiveness of allergy immunotherapy) study have been published in The Lancet Regional Health – Europe

- REACT demonstrated the real-world effectiveness of allergy immunotherapy (AIT) – including ALK products – in allergic rhinitis and asthma, including reduced medication use, fewer asthma exacerbations, and improved asthma control

- The study included patients treated with AIT for the three major allergens: house dust mites, grass pollen and tree pollen

- The benefits were sustained for up to nine years and further substantiate existing evidence from randomised, controlled trials (RCTs), while offering new information about the effects of AIT beyond the usual RCT follow-up period

COPENHAGEN, Denmark, Dec. 1, 2021 /PRNewswire/ -- ALK (ALKB: DC) (OMX: ALK B) (OMX: AKABY) (OMX: AKBLF) today announced that results from the REACT study, a large retrospective real-world study comprising more than 92,000 patients with respiratory allergies, have been published in the research journal, The Lancet Regional Health – Europe (https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(21)00261-1/fulltext) – a regionally-focused journal from the publisher of the world's leading medical research journal, The Lancet. The study was authored by leading experts in the field of allergy immunotherapy and real-world evidence.

The study, which is the first of this type and scale within allergy immunotherapy (AIT), was initiated by ALK in 2019 to evaluate the long-term effects of AIT treatment in allergic rhinitis patients with, or without asthma. ALK worked closely with the scientific community to ensure the robustness of the study and the highest possible quality of the data generated, with the aim of informing the right treatment decisions by providing healthcare professionals with best in both clinical and real-world evidence.  

The primary objective of the study was to assess the impact of AIT on the use of symptomatic treatments by people with allergic rhinitis (AR), with or without asthma.

Sustained long-term effect in real world

In the study, 46,024 patients with AR, with or without asthma, and treated with AIT, were compared to an equal number of similar patients with AR not treated with AIT. AIT treatment was associated with long-term sustained reductions in the use of AR and asthma medication for up to nine years after treatment initiation. Patients with pre-existing asthma treated with AIT were more likely to step down their asthma treatment regimens, with a reduced likelihood of stepping up again. Furthermore, AIT was associated with a preventative effect on severe asthma exacerbations and receiving a pneumonia diagnosis over the nine years. In addition, patients treated with AIT had fewer in-patient stays and shorter stays if admitted to hospital. A low frequency of anaphylaxis cases around AIT initiation was recorded.

REACT complements the findings from RCTs

The disease-modifying effects of AIT had previously been confirmed by ALK in a series of RCTs over the past 10 years. Each of these spanned a five-year period comprising three years of treatment with once-daily SQ grass SLIT-tablets, followed by two years of follow-up. In the REACT study, the real-world effectiveness of AIT was confirmed with a trend lasting more than nine years from treatment initiation, extending the evidence from RCTs over a longer period.

To date, two large RCTs with SQ house dust mite SLIT-tablets have confirmed the efficacy of AIT in the treatment of allergic asthma. The REACT study confirms that these benefits of AIT are also seen in the real world, and that the benefits can be sustained for up to nine years.

REACT has also added knowledge to the existing evidence base from RCTs around potential new benefits of AIT treatment, such as a decreased risk of pneumonia and hospitalisation.

Henrik Jacobi, ALK's Executive Vice President of Research and Development, said: "The core value proposition of AIT is its disease-modifying potential and, in particular, its ability to have a long-lasting effect, even after treatment ends. Long-term data as provided by the REACT study are therefore of fundamental importance."

Henrik Jacobi added: "These results build on ALK's long-standing commitment to conduct RCTs for our AIT products, documenting their benefits for both adults and children. The results also illustrate the advantages of monitoring the effectiveness of AIT products over the longer term, so that the full benefits can be documented and clearly demonstrated to prescribers, payers and patients around the world."

Benedikt Fritzsching, lead author of the REACT study said: "While the efficacy and safety of AIT administered – for example as SLIT-tablets – for the most common respiratory allergies have been demonstrated in RCTs, uncertainty around how AIT works in clinical practice has remained. The findings of the REACT study emphasised AIT as an effective and well-tolerated treatment option for patients with respiratory allergies and demonstrated some interesting new benefits. For healthcare practitioners, these findings provide important complementary evidence that will help inform treatment decisions for the benefit of patients with respiratory allergies."

REACT is part of ALK's new REWEAL programme, which has been initiated to supplement the current evidence base for AIT by collating "real-world" patient data on the use of AIT from independent sources in multiple countries. For more information on REWEAL, visit www.reweal.net.

About ALK

ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,600 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.

About The Lancet Regional Health – Europe

The Lancet Regional Health – Europe is an open access journal, part of The Lancet's global initiative to advocate for health-care quality and access in all regions of the world. The journal fosters the advance of clinical practice and health policy in the European region, with the ultimate goal of improving health outcomes. It aspires to increase the quality of regional and national health research.

The journal publishes high-quality original research that advocates change in, or illuminates, clinical practice and health policy in the European region. It also considers relevant reviews, commentaries, and opinion pieces. The journal invites submissions that are pertaining to regional health topics, including but not limited to prevention and management of infections and non-communicable diseases, improvement of healthy ageing, mental health, and reduction of health inequalities.

The journal can be found at www.thelancet.com/journals/lanepe/home.

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