ALK: EAACI Annual Congress in Barcelona: Analysis of the International Guidelines for House Dust Mite Respiratory Allergy and the Need to Take an Integrated Approach.

HØRSHOLM, Denmark--()--A symposium sponsored by ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) at the European Academy of Allergy and Clinical Immunology (EAACI) annual congress in Barcelona today has signalled the need for consensus in International Guidelines to take a more integrated approach to allergy immunotherapy treatment in respiratory allergy caused by house dust mites (HDM).

The review of International Guidelines on the integrated management of HDM respiratory allergy – both for allergic rhinitis and allergic asthma – was presented by global allergy and clinical immunology specialist Prof Moisés A Calderón.

Prof Calderón explained that asthma and allergic rhinitis are often seen as co-morbid diseases, so there is an identified need for an integrated approach to treating the conditions. Figures show that up to 40 percent of patients with allergic rhinitis are reported to have concomitant allergic asthma. Furthermore, up to 90 percent of patients with asthma are reported to have concomitant allergic rhinitis.

Yet the analysis highlighted that current evidenced-based guidelines are imbalanced. On one hand they support allergy immunotherapy treatment as an option for selected patients with allergic rhinitis caused by HDM. But on the other hand, for patients suffering from HDM-induced allergic asthma that is not well controlled by medium-to-high doses of inhaled corticosteroids, there is insufficient evidence from which to have developed widely supportive guidelines.

Prof Calderón commented: “The review of current published literature shows that only immunotherapy for HDM-induced allergic rhinitis has widespread support from clinical guidelines, with little guidance for allergic asthma. Yet we know HDM-induced allergic rhinitis and allergic asthma are connected and we must therefore become much more coordinated in this area.

To help improve our response more research is needed to strengthen the guidelines so that they better reflect the clinical situation our patients are facing. A joined-up response is so important because at the moment we are failing the people suffering from these difficult conditions.”

ALK is leading the way to gather this evidence by performing the MITRA and MERIT trials for sublingual immunotherapy (SLIT) tablets in patients with HDM-induced allergic asthma and allergic rhinitis. An update on this development program was also presented at the symposium during EAACI by global allergy and clinical immunology specialist Dr Jörg Kleine-Tebbe.

Dr Jörg Kleine-Tebbe added that the SQ-HDM SLIT-tablet was efficacious in both HDM-induced allergic rhinitis and asthma, and also when both manifestations were present simultaneously. The combined evidence showed the highest benefit was in patients not well controlled by pharmacotherapy and that the treatment was well tolerated within the listed safety precautions.

Prof Calderón concluded: “ALK has shown the way forward to developing a more coordinated clinical approach to treating HDM-induced allergic asthma and rhinitis. Now we need a strong push and commitment from the medical community to translate these new data into clinical practice so that patients will directly benefit. Establishing solid, integrated, evidence-based guidelines is a crucial prerequisite to achieving this goal.”

ENDS

About ALK

ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is the world leader in allergy immunotherapy – a unique treatment of the underlying cause of allergy. The company has approximately 1,800 employees with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Merck and Torii to commercialise sublingual allergy immunotherapy tablets in North America and Japan, respectively. The company is headquartered in Hørsholm, Denmark, and listed on NASDAQ OMX Copenhagen. Find more information at www.alk.net.

About the MITRA trial

The trial was a randomised, placebo-controlled, double-blind, multi-national, multi-centre trial involving 834 patients from 13 European countries. Patients were divided into three treatment arms. Patients from the first two groups received two different doses of the tablet, while patients in the third group received placebo. Patients were dosed once daily for up to 18 months. Additionally, all patients received treatment with ICS until the last part of the trial, when ICS usage was reduced by 50% for three months, and then completely withdrawn for another three months. The trial design and success criteria were discussed with the European Medicines Agency (EMA) as scientific advice prior to trial initiation.

About the MERIT trial

The trial was a randomised, placebo-controlled, double-blind, multi-national, multi-centre trial involving 992 patients from 12 European countries. Patients were divided into three treatment arms of equal size. Patients in the first two groups received two different doses of the tablet, while patients in the third group received placebo but had unrestricted access to symptom-relieving medication. The patients received treatment once daily for one year.

About house dust mite allergy

House dust mites (HDM) are the most common cause of allergy in the world. HDM-induced allergy is estimated to affect around 90 million people in Europe, North America and Japan, and more than 100 million in China. It is estimated that up to 13% of patients with HDM-induced allergic rhinitis are poorly controlled with current standard therapies. The condition appears early in life, is present all year round and patients face an elevated risk of developing asthma and other allergies.

Contacts

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

Release Summary

A symposium sponsored by ALK at EAACI signals the need for International Guidelines to take an integrated approach to allergy immunotherapy treatment in respiratory allergy caused by house dust mites.

Contacts

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