Long-term clinical efficacy in grass pollen-induced rhinoconjunctivitis after treatment with SQ-standardized grass allergy immunotherapy tablet.
J Allergy Clin Immunol
; 125(1): 131-8.e1-7, 2010 Jan.
Article
en En
| MEDLINE
| ID: mdl-20109743
ABSTRACT
BACKGROUND:
Sustained and disease-modifying effects of sublingual immunotherapy have never before been confirmed in a large-scale randomized, double-blind, placebo-controlled trial.OBJECTIVE:
We sought to investigate sustained efficacy 1 year after a 3-year period of daily treatment with the SQ-standardized grass allergy immunotherapy tablet Grazax (Phleum pratense 75,000 SQ-T/2,800 BAU; ALK-Abelló, Hørsholm, Denmark).METHODS:
A randomized, double-blind, placebo-controlled, phase III trial including adults with a history of moderate-to-severe grass pollen induced rhinoconjunctivitis inadequately controlled by symptomatic medications. The analysis set comprised 257 subjects at the follow-up. Efficacy end points were rhinoconjunctivitis symptom and medication scores, quality of life, and percentages of symptom and medication free days. Immunologic end points included grass pollen-specific serum IgG4 and IgE-blocking factor. Safety was assessed based on adverse events.RESULTS:
Significant improvements in efficacy were consistently shown during 3 years' treatment. One year after treatment, the active group showed sustained reductions in mean rhinoconjunctivitis symptom scores (26%, P < .001) and medication scores (29%, P = .022) when compared with placebo. This level was similar to the efficacy observed during the 3-year treatment period. The differences in percentages of symptom- and medication-free days were significant during and 1 year after treatment. The active group also reported sustained and significant improvements in quality of life. Sustained clinical benefit was accompanied by immunologic changes. No safety issues were identified.CONCLUSION:
Three years of treatment with the SQ-standardized grass allergy immunotherapy tablet resulted in consistent clinical improvement and accompanying immunologic changes that were sustained 1 year after treatment, which is indicative of disease modification and associated long-term benefits.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Conjuntivitis Alérgica
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Rinitis Alérgica Estacional
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Desensibilización Inmunológica
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Phleum
Tipo de estudio:
Clinical_trials
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Prognostic_studies
Límite:
Adult
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Humans
Idioma:
En
Revista:
J Allergy Clin Immunol
Año:
2010
Tipo del documento:
Article
País de afiliación:
Reino Unido