Sublingual Immunotherapy with a Five-Grass Pollen Tablet in Adult Patients with Allergic Rhinitis: An Open, Prospective, Noninterventional, Multicenter Study.
BACKGROUND
Although the safety and efficacy of sublingual immunotherapy (SLIT) with a five-grass pollen tablet have been demonstrated in randomized clinical trials (RCTs), these outcomes must always be evaluated in real-life medical practice.


METHODS
In a prospective, open-label, noninterventional, "real-life" study in Germany, we evaluated the safety, tolerability, and effectiveness of SLIT with a five-grass pollen tablet in adults with grass-pollen-induced allergic rhinoconjunctivitis.


RESULTS
808 adults were enrolled between September 2008 and December 2009. 35.3% of the participants experienced at least one adverse drug reaction (ADR), the most common of which were mild-to-moderate gastrointestinal and respiratory disorders. Serious ADRs considered causally related to SLIT treatment occurred in four patients. Overall, the five-grass pollen tablet was considered to have good or very good tolerability by most investigators and patients. Treatment was associated with the relief of nasal, ocular, and bronchial symptoms and decreased symptomatic medication use. However, interpretation of clinical improvements was limited by lower atmospheric grass pollen levels during the study season (relative to the preceding season).


CONCLUSIONS
In a large population of patients treated in real-life medical practice, SLIT with a five-grass pollen tablet was safe and well tolerated. The patient-reported symptom relief suggests that SLIT was associated with clinical benefits.
Center for Rhinology and Allergology, 65183 Wiesbaden, Germany ; Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Oliver
O
Pfaar
Private Office, 45130 Essen, Germany.
Heinz-Gerd
HG
Richter
Center for Rhinology and Allergology, 65183 Wiesbaden, Germany.
Ludger
L
Klimek
Stallergenes GmbH, 47475 Kamp-Lintfort, Germany.
Jochen
J
Sieber
Stallergenes GmbH, 47475 Kamp-Lintfort, Germany.
Meike
M
Hadler
Stallergenes GmbH, 47475 Kamp-Lintfort, Germany.
Efstrathios
E
Karagiannis
D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000485:Allergens / Q000276:immunology*; D003233:Conjunctivitis, Allergic / Q000276:immunology; D003888:Desensitization, Immunologic / Q000379:methods; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D006109:Poaceae / Q000276:immunology*; D011058:Pollen / Q000276:immunology*; D011446:Prospective Studies; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology*; D012621:Seasons; D063729:Sublingual Immunotherapy / Q000379:methods; D013607:Tablets / Q000008:administration & dosage*; D055815:Young Adult
D000485:Allergens; D013607:Tablets