The TAPAS study (“Tyrosine Allergoid Paediatric and Adult Study”) is a large, prospective, multicenter, long-term cohort study designed to evaluate the safety, tolerability, and efficacy of subcutaneous allergen immunotherapy (SCIT) with microcrystalline tyrosine-adsorbed allergoids (MATA) in children, adolescents and adults suffering from seasonal allergic rhinitis due to grass or tree pollen.
Background and Rationale
Allergen-specific immunotherapy (AIT) is the only treatment capable of modifying the underlying course of IgE-mediated allergic diseases, such as allergic rhinitis and asthma. Despite its proven benefits, AIT remains underused in pediatric populations, even though children may benefit most-both by reducing symptoms and by preventing the progression from rhinitis to asthma or from single to multiple allergies. Existing guidelines, such as those from the European Academy of Allergy and Clinical Immunology (EAACI), recommend SCIT for moderate to severe allergic rhinitis in both children and adults, but robust, long-term comparative data, especially in children, have been lacking Allergen-specific immunotherapy (AIT) is the only treatment capable of modifying the underlying course of IgE-mediated allergic diseases, such as allergic rhinitis and asthma. Despite its proven benefits, AIT remains underused in pediatric populations, even though children may benefit most-both by reducing symptoms and by preventing the progression from rhinitis to asthma or from single to multiple allergies. Existing guidelines, such as those from the European Academy of Allergy and Clinical Immunology (EAACI), recommend SCIT for moderate to severe allergic rhinitis in both children and adults, but robust, long-term comparative data, especially in children, have been lacking.
Study Design
- Participants: 320 patients (129 aged 5–17 years; 191 adults 18+ years) with allergic rhinitis (with or without mild to moderate asthma) due to grass or tree pollen.
- Intervention: All received SCIT with MATA products (TA top Gräser or TA top Bäume) as part of routine care.
- Duration: Three years of active treatment followed by two years of observation (five years total).
- Endpoints: The primary endpoint was the Combined Symptom and Medication Score (CSMS) during the pollen season, collected via a smartphone app. Secondary endpoints included quality of life (RQLQ), asthma and rhinitis control, and safety (adverse drug reactions).
First-Year Results
- Efficacy: After one year, there was no significant difference in the CSMS between children/adolescents and adults. Both groups experienced a strong and significant reduction in rhinoconjunctivitis and asthma symptoms, with a mean reduction of 29% in rhinitis score and up to 76% in asthma score for children.
- Quality of Life: Both age groups showed improved quality of life during the treatment season.
- Safety: Over 80% of all patients reported no adverse drug reactions. Most side effects were mild and local (e.g., injection site reactions); systemic reactions were rare and occurred at similar rates in both age groups. No fatalities or severe complications were reported.
Implications and Outlook
The interim analysis of the TAPAS study confirms that SCIT with MATA is equally effective and well-tolerated in children, adolescents, and adults. These early results support the broader use of allergen immunotherapy in pediatric patients, potentially closing a significant evidence gap and encouraging greater acceptance of this disease-modifying treatment in younger populations.
The full five-year results will provide further insight into the long-term and disease-modifying effects of this therapy, especially regarding the prevention of new allergies and asthma development in children.
Funding: This study is funded by an unrestricted research grant from Bencard Allergie GmbH, Munich, Germany.
