Moesges, Ralph, Breitrueck, Nils Y., Allekotte, Silke, Shah-Hosseini, Kija ORCID: 0000-0001-9616-6942, Zieglmayer, Petra, Birkholz, Katrin, Hess, Mark, Bastl, Maximilian ORCID: 0000-0002-2182-0409, Bastl, Katharina, Berger, Uwe, Kramer, Matthias F. and Guethoff, Sonja (2019). Shortened up-dosing with sublingual immunotherapy drops containing tree allergens is well tolerated and elicits dose-dependent clinical effects during the first pollen season. World Allergy Organ. J., 12 (2). AMSTERDAM: ELSEVIER. ISSN 1939-4551

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Abstract

Background: This study compared a rapid home-based up-dosing schedule for sublingual immunotherapy (SLIT) drops containing tree pollen allergens with two previously established schedules. Furthermore, the clinical effect of the SLIT was investigated with respect to patients' first pollen season under treatment. Methods: In this open-label, prospective, patient-preference, non-interventional study, local and systemic reactions were compared between three up-dosing groups using a SLIT formulation containing birch, alder, and hazel pollen extracts (ORALVAC (R) Compact Baume). Clinical improvement after patients' first season under treatment was analysed using symptom scores, ARIA classification, symptom control, and the use of symptomatic medication and was compared with data from the previous, pre-treatment pollen season. As the real-life study design allowed no placebo group, the late-treated patients (co-seasonal) served as a control, and crowd-sourced symptom data from persons with hay fever were used from a free web-based online diary. Results: In 33 study centres in Germany and Austria, 164 patients were included. The treatment was well tolerated, without difference between the groups during the up-dosing phase. At the end of the assessment, 96.1% rated the tolerability of the treatment as good or very good. Local reactions were mostly mild in severity and no serious adverse events occurred. Symptom scores decreased from the 2016 pollen season to the 2017 pollen season. As for the ARIA classification, 79.0% of patients had persistent, moderate-to-severe rhinitis before treatment, but only 18.6% had the same classification after treatment. In all, 62.4% of patients achieved symptom control, and 34.3% of patients required no symptomatic medication after treatment. The rhinoconjunctivitis score was 34.4% lower for pre-seasonal treatment initiation than for the control group. Crowd-sourced symptom load indices showed that the 2016 season caused slightly more symptoms; however, it is assumed that this difference of 0.3-0.5 (score range 0-10) was of less clinical relevance. Conclusion: The treatment administered using the rapid home-based up-dosing schedule was safe and well tolerated. Symptom relief and reduction in medication use were observed during the first pollen season with SLIT.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Moesges, RalphUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Breitrueck, Nils Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Allekotte, SilkeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shah-Hosseini, KijaUNSPECIFIEDorcid.org/0000-0001-9616-6942UNSPECIFIED
Zieglmayer, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Birkholz, KatrinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hess, MarkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bastl, MaximilianUNSPECIFIEDorcid.org/0000-0002-2182-0409UNSPECIFIED
Bastl, KatharinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berger, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kramer, Matthias F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Guethoff, SonjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-139343
DOI: 10.1016/j.waojou.2019.100012
Journal or Publication Title: World Allergy Organ. J.
Volume: 12
Number: 2
Date: 2019
Publisher: ELSEVIER
Place of Publication: AMSTERDAM
ISSN: 1939-4551
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ADVERSE SYSTEMIC REACTIONS; SUBCUTANEOUS IMMUNOTHERAPY; CLUSTER IMMUNOTHERAPY; EUROPEAN SURVEY; SYMPTOM LOAD; GRASS; RHINITIS; SAFETY; TOLERABILITY; SCHEDULESMultiple languages
Allergy; ImmunologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/13934

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