title: Efficacy and safety of 5-grass pollen sublingual immunotherapy tablets in patients with different clinical profiles of allergic rhinoconjunctivitis.
abstract: BACKGROUND
  The optimal dose of grass pollen tablets for sublingual immunotherapy (SLIT) in allergic rhinoconjunctivitis patients was previously established in a multinational, randomized, double-blind, placebo-controlled study in 628 adults. Patients were randomized to receive once-daily 5-grass pollen sublingual tablets of 100 IR (index of reactivity), 300 IR or 500 IR, or placebo starting 4 months before the pollen season.
  
  
  OBJECTIVE
  The aim of this complementary analysis was to determine whether 300 IR 5-grass pollen SLIT-tablets is effective in different subtypes of patients who are allergic to grass pollen.
  
  
  METHODS
  Different subgroups could be identified regarding comorbidities (with or without asthma during the grass-pollen season), sensitization (mono/polysensitization) and symptom severity. An additional exploratory analysis was performed within four subgroups based on pre-treatment assessment: Group 1=high specific IgE; Group 2=high symptom scores; Group 3=high skin sensitivity; Group 4=any of Group 1, 2 or 3.
  
  
  RESULTS
  Asthma and sensitization status were not significant covariates as the average Rhinoconjunctivitis Total Symptom Score (RTSS) was identical for patients with and without grass-pollen asthma, as well as for mono- and polysensitized patients. Across the four subgroups, average RTSSs (+/- SD) for the optimal dosage (300 IR) were 3.91 +/- 3.16, 3.83 +/- 3.14, 2.55 +/- 2.13 and 3.61 +/- 2.97, for subgroups 1, 2, 3 and 4, respectively. ANCOVA showed that in Group 1 average RTSS did not differ significantly with different doses of SLIT. In Groups 2, 3 and 4, doses of 300 IR and 500 IR were significantly more effective than 100 IR and placebo (P< or =0.035). All doses of SLIT administered in this study can be considered safe in the patients investigated.
  
  
  CONCLUSIONS
  The risk-benefit ratio validates the use of 300 IR tablets in clinical practice in all of these patient subgroups, regardless of severity profile, sensitization status and presence of asthma.
authors.affiliation: Allergy Clinic, National University Hospital, Blegdamsvej 9, Copenhagen, Denmark. hans.joergen.malling@rh.regionh.dk
authors.forename: H-J
authors.initials: HJ
authors.lastname: Malling
authors.forename: A
authors.initials: A
authors.lastname: Montagut
authors.forename: M
authors.initials: M
authors.lastname: Melac
authors.forename: G
authors.initials: G
authors.lastname: Patriarca
authors.forename: P
authors.initials: P
authors.lastname: Panzner
authors.forename: E
authors.initials: E
authors.lastname: Seberova
authors.forename: A
authors.initials: A
authors.lastname: Didier
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D052179:Antigens, Plant / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D001249:Asthma / Q000453:epidemiology; D015897:Comorbidity; D003233:Conjunctivitis, Allergic / Q000453:epidemiology / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D006109:Poaceae / Q000276:immunology*; D011058:Pollen / Q000276:immunology*; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000453:epidemiology / Q000628:therapy*; D018570:Risk Assessment; D013607:Tablets; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D052179:Antigens, Plant; D013607:Tablets