title: Efficacy and safety of the SQ-standardized grass allergy immunotherapy tablet in mono- and polysensitized subjects.
abstract: The efficacy of single-allergen-specific immunotherapy in polysensitized subjects is a matter of debate. We therefore performed a post hoc analysis of pooled data from six randomized, double-blind, placebo-controlled trials (N = 1871) comparing the efficacy and safety of the SQ-standardized grass allergy immunotherapy tablet (AIT), Grazax (Phleum pratense 75 000 SQ-T/2800 BAU, ALK, Denmark), in mono- and polysensitized subjects. A statistically significant reduction in the mean total combined symptom/medication score (TCS) of 27% was demonstrated in actively treated subjects compared with placebo (P < 0.0001). This was not dependent on sensitization status (P = 0.5772), suggesting a similar treatment effect in mono- and polysensitized subjects (i.e. reductions of the TCSs of 28% and 26%, respectively, both P < 0.0001). Finally, a comparable and favourable safety profile of grass AIT was demonstrated in the two subgroups. Thus, no difference in efficacy and safety of single-allergen grass AIT was observed between mono- and polysensitized subjects.
authors.affiliation: Department of Medicine, Division of Allergy and Immunology, National Jewish Health, Denver, CO, USA.
authors.forename: H
authors.initials: H
authors.lastname: Nelson
authors.forename: M
authors.initials: M
authors.lastname: Blaiss
authors.forename: H
authors.initials: H
authors.lastname: Nolte
authors.forename: S Ø
authors.initials: SØ
authors.lastname: Würtz
authors.forename: J S
authors.initials: JS
authors.lastname: Andersen
authors.forename: S R
authors.initials: SR
authors.lastname: Durham
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D052179:Antigens, Plant / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D061214:Patient Safety; D008517:Phytotherapy / Q000379:methods; D010936:Plant Extracts / Q000627:therapeutic use*; D006109:Poaceae / Q000276:immunology*; D016032:Randomized Controlled Trials as Topic; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D018570:Risk Assessment; D012720:Severity of Illness Index; D013607:Tablets / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D052179:Antigens, Plant; C551013:Grazax; D010936:Plant Extracts; D013607:Tablets