title: Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study.
abstract: BACKGROUND
  The majority of allergic patients are poly-sensitized. For causal treatment by allergy immunotherapy (AIT) a single or few allergen products containing the clinically most relevant allergens are applied, but few data on tolerability of multiple application of AIT is available. The aim of our study was to investigate safety and tolerability in patients who started treatment by sublingual immunotherapy (SLIT) with the standardised SQ(®) grass SLIT-tablet and were treated with concomitant AIT products.
  
  
  METHODS
  In a non-interventional, open-label, observational study in Germany treatment of patients with the SQ(®) grass SLIT-tablet and concomitant AIT (SCIT or SLIT) was documented between January 2012 and January 2014. Patients were followed at visits at first administration of the SQ(®) grass SLIT-tablet and after 1-3 months of treatment. Tolerability of the treatment with the SQ(®) grass SLIT-tablet and concomitant AIT were assessed by the physician and administration of AIT and adverse events (AEs) were recorded by the patients in diaries. AEs and adverse drug reactions (ADRs) were coded by using the Medical Dictionary for Regulatory Activities.
  
  
  RESULTS
  In total, 181 patients were documented by 48 allergists and 160 patients treated with a concomitant AIT (SCIT 130, SLIT 30). AEs were reported in 58 (36.3 %) patients with concomitant AIT, and AEs considered related with the SQ(®) grass SLIT-tablet in 49 (30.6 %) and with concomitant AIT in 18 (11.3 %) patients. Treatment was discontinued due to ADRs in 12 (7.5 %) patients and severity of ADRs was assessed mild or moderate in 29 (18.1 %), and severe in 20 (12.5 %) patients. Most common reactions were localised at the application site of the SQ(®) grass SLIT-tablet as oral pruritus, throat irritation, oedema mouth and paraesthesia oral; no serious ADRs were reported. Overall tolerability of the SQ(®) grass SLIT-tablet if given with concomitant AIT was assessed as "good" or "very good" by 91.0 % of patients and 91.6 % of physicians.
  
  
  CONCLUSIONS
  In comparison to data from previous studies no increase in frequency of AEs or change in the tolerability profile was observed when SLIT with the SQ(®) grass SLIT-tablet was administered with concomitant SCIT or SLIT.
authors.affiliation: HNO-Praxis, 73614 Schorndorf, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Reiber
authors.affiliation: HNO-Gemeinschaftspraxis, 78166 Donaueschingen, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Keller
authors.affiliation: HNO-Gemeinschaftspraxis, 78166 Donaueschingen, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Keller
authors.affiliation: Clinical Development, ALK-Abelló Arzneimittel GmbH, 22763 Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Wolf
authors.affiliation: Institut für angewandte Statistik Dr. Jörg Schnitker GmbH, 33602 Bielefeld, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Schnitker
authors.affiliation: Medizin, ALK-Abelló Arzneimittel GmbH, 22763 Hamburg, Germany ; Clinic for Otolaryngology, Universitätsklinikum Carl Gustav Carus, 01307 Dresden, Germany.
authors.forename: Eike
authors.initials: E
authors.lastname: Wüstenberg
keywords: Allergic rhinoconjunctivitis; GRAZAX; Grass pollen; Multiple allergy immunotherapy; Polysensitization; Subcutaneous immunotherapy; Sublingual immunotherapy; Tolerability