Immunotherapy is the only treatment for
allergy that alters the natural course of this disease. Sublingual immunotherapy has been developed to make
immunotherapy more suitable for allergic patients. In the largest clinical program ever conducted with grass
allergen-specific
immunotherapy, over 2000 adults and more than 500 children have been exposed to
Grazax(®) (ALK-Abello A/S, Hoersholm, Denmark).
Grazax is an oral lyophilisate
tablet (
allergy immunotherapy tablet [AIT]) for
sublingual administration, containing 75,000 standardized quality
tablet units of
allergen extract of grass pollen (Phleum pratense).
Grazax is indicated for treatment of grass pollen-induced
rhinitis and
conjunctivitis in adult and pediatric patients. Results from the GT-08 trial (first, second and third treatment years) showed a reduction of 31, 36 and 29%, respectively, in symptom scores and a reduction of 38, 45 and 40% of medication scores, respectively, compared with placebo. Subjects treated with
Grazax also had an increased number of well days and a relevant improvement in quality of life. More subjects experienced excellent and complete rhinoconjunctivitis control in comparison with patients treated with symptomatic medications only.
Grazax treatment is also associated with a sustained and relevant increase of specific
IgG4. This increase is also observed after stopping AIT treatment. The most common adverse events related to
Grazax treatment are local reactions, such as oral itch,
edema of the mouth, ear
pruritus, throat irritation and
sneezing. Clinical efficacy of
Grazax is observed also after 1 and 2 years of follow-up after stopping the AIT treatment.
Grazax is efficacious and safe for treatment of grass-pollen rhinoconjunctivitis in both adults and children.
Grazax is the first AIT showing a disease-modifying effect on grass pollen-induced allergic rhinoconjuctivitis.