PMID- 26958338
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160309
LR  - 20200929
IS  - 2045-7022 (Print)
IS  - 2045-7022 (Electronic)
IS  - 2045-7022 (Linking)
VI  - 6
DP  - 2015
TI  - Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in 
      patients treated with concomitant allergy immunotherapy: a non-interventional 
      observational study.
PG  - 9
LID - 10.1186/s13601-016-0097-8 [doi]
LID - 9
AB  - 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((R)) 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((R)) 
      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((R)) grass SLIT-tablet and after 1-3 months of treatment. 
      Tolerability of the treatment with the SQ((R)) 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((R)) 
      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((R)) grass SLIT-tablet as oral pruritus, throat irritation, oedema mouth 
      and paraesthesia oral; no serious ADRs were reported. Overall tolerability of the 
      SQ((R)) 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((R)) grass 
      SLIT-tablet was administered with concomitant SCIT or SLIT.
FAU - Reiber, Rainer
AU  - Reiber R
AD  - HNO-Praxis, 73614 Schorndorf, Germany.
FAU - Keller, Martina
AU  - Keller M
AD  - HNO-Gemeinschaftspraxis, 78166 Donaueschingen, Germany.
FAU - Keller, Winfried
AU  - Keller W
AD  - HNO-Gemeinschaftspraxis, 78166 Donaueschingen, Germany.
FAU - Wolf, Hendrik
AU  - Wolf H
AD  - Clinical Development, ALK-Abello Arzneimittel GmbH, 22763 Hamburg, Germany.
FAU - Schnitker, Jorg
AU  - Schnitker J
AD  - Institut fur angewandte Statistik Dr. Jorg Schnitker GmbH, 33602 Bielefeld, 
      Germany.
FAU - Wustenberg, Eike
AU  - Wustenberg E
AD  - Medizin, ALK-Abello Arzneimittel GmbH, 22763 Hamburg, Germany ; Clinic for 
      Otolaryngology, Universitatsklinikum Carl Gustav Carus, 01307 Dresden, Germany.
LA  - eng
PT  - Journal Article
DEP - 20160308
PL  - England
TA  - Clin Transl Allergy
JT  - Clinical and translational allergy
JID - 101576043
PMC - PMC4782305
OTO - NOTNLM
OT  - Allergic rhinoconjunctivitis
OT  - GRAZAX
OT  - Grass pollen
OT  - Multiple allergy immunotherapy
OT  - Polysensitization
OT  - Subcutaneous immunotherapy
OT  - Sublingual immunotherapy
OT  - Tolerability
EDAT- 2015/01/01 00:00
MHDA- 2015/01/01 00:01
PMCR- 2016/03/08
CRDT- 2016/03/10 06:00
PHST- 2015/11/27 00:00 [received]
PHST- 2016/01/28 00:00 [accepted]
PHST- 2016/03/10 06:00 [entrez]
PHST- 2015/01/01 00:00 [pubmed]
PHST- 2015/01/01 00:01 [medline]
PHST- 2016/03/08 00:00 [pmc-release]
AID - 97 [pii]
AID - 10.1186/s13601-016-0097-8 [doi]
PST - epublish
SO  - Clin Transl Allergy. 2016 Mar 8;6:9. doi: 10.1186/s13601-016-0097-8. eCollection 
      2015.