New, large, ‘real-world evidence’ study by ALK of AIT’s long-term effects on allergy and asthma presented at EAACI Congress

• Leading allergy researchers present data from a new, large, ‘real-world evidence’ study of allergy immunotherapy at EAACI Annual Congress in Krakow, Poland

• Study assessed long-term outcomes in allergic rhinitis and asthma following treatment with AIT

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the world’s leading allergy experts have been presented with data from its recent long-term, ‘real-world evidence’ study, ‘REAl world effeCtiveness of allergy immunoTherapy (REACT), at one of the world’s most important annual allergy congresses.

The study was initiated by ALK to evaluate the long-term effects of allergy immunotherapy (AIT) treatment in patients suffering from allergic rhinitis with or without concomitant asthma. It included more than 90,000 patients, equally split between those receiving AIT treatment and a control group, and aimed to address unanswered questions in the study of AIT use. For example: Can results from randomised, controlled trials be generalised to broader patient populations in real-life clinical practice? Are the benefits of AIT treatment sustained in the long-term, beyond what we know from clinical studies? Can AIT lead to improved asthma control in the long-term? And, are there novel findings, such as a reduced risk of respiratory tract infections following AIT treatment?

ALK worked closely with the scientific allergy 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.

Real patients, real questions, answered
‘Real-world data’ are information gathered from patients in a real-life setting during normal clinical practice. This allowed the REACT study to collate a wider range of data, covering a larger group of patients, for a longer period of time, and spanning a wider range of outcomes, than are typically possible for registration trials. Data gathered included the number of prescriptions issued, confirmed disease diagnoses, as well as hospitalisations and costs to the healthcare system.

The primary objective of the study was to assess the impact of AIT on the use of symptomatic treatments by people with allergic rhinitis with, or without, asthma. The hypothesis was that AIT is associated with long-term, sustained reductions in the use of such medicines.

Long-term outcomes
The findings were presented for the first time at an ALK-sponsored symposium on the impact of respiratory allergies on patients and society and the potential benefits of treating patients with AIT, which was held as part of the Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI), in Krakow, Poland. Titled ‘Best in both worlds: Demonstrating long-term effectiveness of AIT in the real world’, the ALK symposium reviewed the evidence-gathering journey of AIT, and discussed how real-world evidence can now be used to complement evidence generated by randomised, controlled, clinical trials.

In his presentation during the symposium, ‘The big REWEAL: Real patients. Real questions. Answered’, Dr. Benedikt Fritzsching, MD, registered allergist and apl. Professor of the University of Heidelberg said: “This study gives us a ‘whole population’ view of allergy patients spanning almost a decade. Such a dataset is unprecedented in the study of allergic disease, and it gives us a much clearer picture of how this disease responds to treatment with AIT.”

Unfolding the value proposition of AIT
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. The REACT study looks to answer questions that, due to their design, are not posed during registration trials, so that we can expand our understanding of the full benefits of AIT treatment and duration of those effects in the real world.”

REACT is part of ALK’s extensive 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

ALK-Abelló A/S

For further information please contact:

Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525

Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014

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 2,500 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.

About the European Academy of Allergy and Clinical Immunology (EAACI) Congress
The EAACI Annual Congress is the foremost event of its kind, drawing allergy experts, policy makers and science media from all over the world. Its scientific programme and industry-sponsored sessions provide an important update on the latest research, trends and product launches in allergy treatment. Find more information at https://www.eaaci.org/eaaci-congresses/eaaci-2021

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• REACT_EAACI21 - press release 10072021