First sublingual allergy immunotherapy for tree pollen allergy sufferers

For people who are allergic to pollen from birch & co, a new sustainable therapy option will soon be available. Desensitization treats the cause of the allergy and improves the quality of life of allergy sufferers. The ideal start of therapy is after the end of the pollen season of the early bloomers, i.e. in summer or fall.

(red) ^Itulazax® [1] will be available in Switzerland from September 2020. It is the world’s first approved tablet for allergen-specific immunotherapy (AIT) for early blossom allergy. For allergy sufferers against other inhalative allergies (grasses and house dust mites), a corresponding treatment option has existed for some time. Both Swissmedic and the European Medicines Agency EMA have approved ^Itulazax® [1] in patients 12 years of age and older for the indication of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from trees of the birch homologous group (birch, alder, hornbeam, hazel, oak, chestnut, beech). In Europe, several million people suffer from allergies to early blossom tree pollen. Sublingual AIT is used for desensitization, treats the cause of the allergy and thus can improve the quality of life of allergy sufferers.

Well-tolerated therapy option with sustained efficacy

Efficacy and safety of ^Itulazax® were investigated in two randomized, double-blind placebo-controlled multinational studies [2]: A significant reduction in the combined total score of 40% during the birch pollen season compared to placebo was demonstrated. In this study, the clinical relevance level defined by the World Allergy Organization (WAO) [3] (20% efficacy vs. placebo) was clearly exceeded. In addition, there was a significant reduction in the combined total score of 37% vs. placebo throughout the early blooming season [2]. This makes ^Itulazax® the first compound to demonstrate efficacy throughout the early bloomer season, with evidence-based benefits of significant improvement in disease control, increased quality of life, and reduced need for allergy medications.

Simple and patient-friendly handling

^Itulazax® [1] is an uncomplicated treatment option without the need for up-dosing. The good safety profile makes ^Itulazax® suitable for use at home after monitoring of initial administration in the office. Like the sublingual AITs against grass pollen and house dust mites (^Grazax® and ^Acarizax®) [1], ^Itulazax® is also manufactured using Zydis technology and dissolves under the tongue within seconds without leaving any residue. There are no special storage conditions and ingestion is possible at any time and flexibly, as no water is required. When prescribing ^Itulazax® it is advisable, as with subcutaneous therapy, to arrange regular short appointments with the patients in order to maintain regular contact with the patient and thus to be able to assess the course of the therapy and to remind the patient of the importance of regular, once-daily administration for the success of the therapy. It is important to educate the patient about the treatment and possible immune system reactions, as local allergic reactions (such as a tingling sensation in the mouth) may occur with sublingual immunotherapy in the first few weeks after starting the therapy. These usually appear shortly after ingestion and do not reappear within a few days. To prevent these possible side effects, the following measures may be helpful: drink water before ingestion, take an antihistamine after consulting with your doctor before ingestion, place a small piece of ice under your tongue starting 5 minutes after ingestion, eat and/or drink something.

Source: ALK

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