title: Health-Related Quality of Life During Routine Treatment with the SQ-Standardised Grass Allergy Immunotherapy Tablet: A Non-Interventional Observational Study.
abstract: OBJECTIVE
  Allergy immunotherapy (AIT) with the SQ(®) grass sublingual immunotherapy (SLIT)-tablet has been shown to be efficacious, well-tolerated and to improve disease-specific health-related quality of life (HRQoL) in controlled clinical trials. The aim of our study was to investigate HRQoL in patients with allergic rhinoconjunctivitis routinely treated with the SLIT-tablet and taking symptomatic medication as needed compared with patients treated only with symptomatic medication.
  
  
  METHODS
  In a non-interventional, open-label study, patients treated with the SLIT-tablet were observed for about 12 months compared with patients only symptomatically treated. Patients assessed their HRQoL with the 12-Item Short Form Health Survey (SF-12) and the Rhinitis Quality of Life Questionnaire (RQLQ) in the grass pollen seasons (GPS) at baseline (GPS1, HRQoL1), after GPS1 (HRQoL2) and in the following GPS (GPS2, HRQoL3). Tolerability, compliance, symptoms and medication use were assessed in the SLIT-tablet group by the physician.
  
  
  RESULTS
  Overall, data were analysed in 576 patients. Mean differences (±SD) in overall scores for HRQoL3 versus HRQoL1 (186 patients) of SF-12 were +11.4 ± 16.8 (SLIT-tablet) and -3.4 ± 15.7 (symptomatic medication), (p < 0.0001), and of RQLQ -1.31 ± 1.07 and +0.10 ± 0.74 (p < 0.001), and for HRQoL3 versus HRQoL2 (238 patients) of SF-12 -1.6 ± 15.3 and -10.0 ± 14.1 (p = 0.0003), and of RQLQ +0.22 ± 1.29 and +1.24 ± 1.30 (p < 0.0001). Tolerability and adherence for the SLIT-tablet were comparable with data of other non-interventional studies.
  
  
  CONCLUSIONS
  Routine treatment with the SQ(®) grass SLIT-tablet resulted in clear improvements in disease-specific and general quality of life, while no improvements were observed in patients treated only symptomatically.
authors.affiliation: HNO Praxis am Neckar, 69120, Heidelberg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Horn
authors.affiliation: HNO Praxis am Neckar, 69120, Heidelberg, Germany.
authors.forename: Herbert
authors.initials: H
authors.lastname: Zeuner
authors.affiliation: ALK-Abelló Arzneimittel GmbH, Clinical Development/Medical Department, Griegstrasse 75, Haus 25, 22763, Hamburg, Germany. hendrik.wolf@alk.net.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Wolf
authors.affiliation: Institut für angewandte Statistik Dr. Jörg Schnitker GmbH, 33647, Bielefeld, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Schnitker
authors.affiliation: ALK-Abelló Arzneimittel GmbH, Clinical Development/Medical Department, Griegstrasse 75, Haus 25, 22763, Hamburg, Germany.|Clinic for Otolaryngology, Universitätsklinikum Carl Gustav Carus, 01307, Dresden, Germany.
authors.forename: Eike
authors.initials: E
authors.lastname: Wüstenberg
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003231:Conjunctivitis / Q000276:immunology / Q000517:prevention & control; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000523:psychology* / Q000628:therapy*; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D006109:Poaceae / Q000276:immunology*; D011058:Pollen / Q000276:immunology; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000517:prevention & control; D011795:Surveys and Questionnaires; D013607:Tablets; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D013607:Tablets