Cargando…

Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Reiber, Rainer, Keller, Martina, Keller, Winfried, Wolf, Hendrik, Schnitker, Jörg, Wüstenberg, Eike
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4782305/
https://www.ncbi.nlm.nih.gov/pubmed/26958338
http://dx.doi.org/10.1186/s13601-016-0097-8
_version_ 1782419925471592448
author Reiber, Rainer
Keller, Martina
Keller, Winfried
Wolf, Hendrik
Schnitker, Jörg
Wüstenberg, Eike
author_facet Reiber, Rainer
Keller, Martina
Keller, Winfried
Wolf, Hendrik
Schnitker, Jörg
Wüstenberg, Eike
author_sort Reiber, Rainer
collection PubMed
description 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.
format Online
Article
Text
id pubmed-4782305
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-47823052016-03-09 Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study Reiber, Rainer Keller, Martina Keller, Winfried Wolf, Hendrik Schnitker, Jörg Wüstenberg, Eike Clin Transl Allergy Research 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. BioMed Central 2016-03-08 /pmc/articles/PMC4782305/ /pubmed/26958338 http://dx.doi.org/10.1186/s13601-016-0097-8 Text en © Reiber et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Reiber, Rainer
Keller, Martina
Keller, Winfried
Wolf, Hendrik
Schnitker, Jörg
Wüstenberg, Eike
Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study
title Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study
title_full Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study
title_fullStr Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study
title_full_unstemmed Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study
title_short Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study
title_sort tolerability of the sq-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4782305/
https://www.ncbi.nlm.nih.gov/pubmed/26958338
http://dx.doi.org/10.1186/s13601-016-0097-8
work_keys_str_mv AT reiberrainer tolerabilityofthesqstandardisedgrasssublingualimmunotherapytabletinpatientstreatedwithconcomitantallergyimmunotherapyanoninterventionalobservationalstudy
AT kellermartina tolerabilityofthesqstandardisedgrasssublingualimmunotherapytabletinpatientstreatedwithconcomitantallergyimmunotherapyanoninterventionalobservationalstudy
AT kellerwinfried tolerabilityofthesqstandardisedgrasssublingualimmunotherapytabletinpatientstreatedwithconcomitantallergyimmunotherapyanoninterventionalobservationalstudy
AT wolfhendrik tolerabilityofthesqstandardisedgrasssublingualimmunotherapytabletinpatientstreatedwithconcomitantallergyimmunotherapyanoninterventionalobservationalstudy
AT schnitkerjorg tolerabilityofthesqstandardisedgrasssublingualimmunotherapytabletinpatientstreatedwithconcomitantallergyimmunotherapyanoninterventionalobservationalstudy
AT wustenbergeike tolerabilityofthesqstandardisedgrasssublingualimmunotherapytabletinpatientstreatedwithconcomitantallergyimmunotherapyanoninterventionalobservationalstudy