Evidence for SQ allergy immunotherapy

Moving from experience-based to evidence-based medicine in allergy immunotherapy

Over recent decades, AIT has moved from experience-based practice towards more evidence-based medicine. SQ AIT sublingual immunotherapy (SLIT), administered as a once-daily tablet, has consistently demonstrated reductions in both symptoms and the use of symptom-relieving medications such as antihistamines and intranasal corticosteroids (INCS). The efficacy has been evaluated in patients diagnosed with allergic rhinitis, whose symptoms were not well-controlled by symptom-relieving medications alone. Based on the evidence from comprehensive clinical development programmes, SQ SLIT-tablets are indicated for allergic rhinitis (AR) in patients who have been diagnosed with grass, tree or HDM allergy. Please find the specific indications for each SQ SLIT-tablet below.

In addition to being able to reduce symptoms and the use of symptom-relieving medications, the SQ grass SLIT-tablet is also indicated as a disease-modifying treatment based on data from long-term (5 year) randomised, controlled trials (read more here) and the SQ HDM SLIT-tablet is indicated for both AR and allergic asthma that are not well controlled by inhaled corticosteroids (ICS) (read more here).

Today, the efficacy of SQ SLIT-tablets has been evaluated across multiple clinical development programmes enrolling more than 22,000 patients. In large, randomised, placebo-controlled trials, the efficacy was typically assessed via a total combined score, calculated from daily symptom and medication scores, i.e., use of symptom-relieving medications such as antihistamines or INCS. Across both perennial allergies, such as HDM, and seasonal pollen allergies, such as grass and tree, significant reductions in both symptom and medication scores were demonstrated versus placebo. In addition, similar efficacy for the treatment of allergic rhinitis has been confirmed for SQ grass SLIT-tablets in children (≥5-17 years) and for SQ HDM SLIT-tablet in adolescents (≥12-17 years) as was seen in adults.

Please note SQ HDM SLIT-tablet and SQ grass SLIT-tablet is based on medians, while SQ tree SLIT-tablet is adjusted means.

A similar safety profile has been reported for the three SQ SLIT-tablets, with local side effects being an anticipated reaction of the immune system to the allergen released under the tongue from the SQ SLIT-tablets. These are mostly mild-to-moderate in severity and transient in nature. The most common side effects include oral pruritis, tongue pruritis, ear pruritis, throat irritation and mouth oedema.

For more details, please click relevant product:  SQ HDM SLIT-tablet SQ grass SLIT-tablet SQ tree SLIT-tablet