Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy.
BACKGROUND
Immunotherapy with the SQ-standardized grass tablet Grazax is efficacious and well-tolerated in adult patients with rhinoconjunctivitis. Allergic asthma and rhinoconjunctivitis are closely linked, and a strategy combining treatment of the upper and lower airways is recommended.


OBJECTIVE
To investigate the efficacy of treatment with the grass tablet on grass pollen-induced rhinoconjunctivitis and asthma as well as the immunologic response and the safety profile in children.


METHODS
A total of 253 children age 5 to 16 years, with grass pollen-induced rhinoconjunctivitis with/without asthma, were randomized 1:1 to active treatment or placebo. Treatment was initiated 8 to 23 weeks before the start of the grass pollen season 2007 and continued throughout the entire season. Symptomatic medication was provided as relief medication to both groups in a stepwise fashion. Primary endpoints were rhinoconjunctivitis symptom and medication scores.


RESULTS
The rhinoconjunctivitis symptom and medication scores and the asthma symptom score were all statistically significantly different between the 2 treatment groups. The differences in medians relative to placebo were 24%, 34%, and 64% in favor of active treatment. The immunologic response was similar to that observed in adults. The most common adverse reaction was oral pruritus, reported by 40 subjects (32%) in the active and 3 (2%) in the placebo group. Six subjects withdrew because of adverse events. No serious adverse events were assessed as treatment-related.


CONCLUSIONS
Immunotherapy with the grass tablet reduced grass pollen-induced rhinoconjunctivitis and asthma symptoms in a pediatric population and introduced an immunomodulatory response, consistent with treatment of the underlying allergic disease. The treatment was well tolerated.
Bufe
Albrecht
A
Experimental Pneumonology, Ruhr-University Bochum, Bergmannsheil-University-Clinics, Bochum, Germany. albrecht.bufe@rub.de
Eberle
Peter
P
Franke-Beckmann
Eivy
E
Funck
Jürgen
J
Kimmig
Martin
M
Klimek
Ludger
L
Knecht
Roland
R
Stephan
Volker
V
Tholstrup
Bente
B
Weisshaar
Christian
C
Kaiser
Friedrich
F
D000293:Adolescent; D052179:Antigens, Plant / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000276:immunology / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000276:immunology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D006109:Poaceae / Q000009:adverse effects / Q000276:immunology; D011058:Pollen / Q000009:adverse effects / Q000276:immunology; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy*; D013997:Time Factors
D052179:Antigens, Plant