Stefan Zielen, Piotr Kuna, Werner Aberer, Sabine Laßmann, Oliver Pfaar, Ludger Klimek, Anette Wade, Karolin Kluehr, Jennifer Raab, Dorothea Wessiepe, Denise Lee, Matthias F. Kramer, Kulasiri Gunawardena, Timothy Higenbottam, Matthew D. Heath, Murray A. Skinner, Pieter-Jan de Kam
- Background: Pollinex Quattro Grass (PQ Grass) is an effective, well-tolerated, short pre-seasonal subcutaneous immunotherapy to treat seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen. In this Phase II study, 4 cumulative doses of PQ Grass and placebo were evaluated to determine its optimal cumulative dose.
Methods: Patients with grass pollen-induced SAR were randomised to either a cumulative dose of PQ Grass (5100, 14400, 27600 and 35600 SU) or placebo, administered as 6 weekly subcutaneous injections over 31–41 days (EudraCT number 2017-000333-31). Standardized conjunctival provocation tests (CPT) using grass pollen allergen extract were performed at screening, baseline and post-treatment to determine the total symptom score (TSS) assessed approximately 4 weeks after dosing. Three models were pre-defined (Emax, logistic, and linear in log-dose model) to evaluate a dose response relationship.
Results: In total, 95.5% of the 447 randomized patients received all 6 injections. A highly statistically significant (p < 0.0001), monotonic dose response was observed for all three pre-specified models. All treatment groups showed a statistically significant decrease from baseline in TSS compared to placebo, with the largest decrease observed after 27600 SU (p < 0.0001). The full course of 6 injections was completed by 95.5% of patients. Treatment-emergent adverse events were similar across PQ Grass groups, and mostly mild and transient in nature.
Conclusions: PQ Grass demonstrated a strong curvilinear dose response in TSS following CPT without compromising its safety profile.
MetadatenAuthor: | Stefan ZielenORCiDGND, Piotr KunaORCiDGND, Werner Aberer, Sabine Laßmann, Oliver PfaarORCiDGND, Ludger KlimekORCiDGND, Anette Wade, Karolin Kluehr, Jennifer RaabORCiD, Dorothea Wessiepe, Denise Lee, Matthias F. KramerORCiDGND, Kulasiri Gunawardena, Timothy HigenbottamORCiD, Matthew D. HeathORCiD, Murray A. SkinnerORCiD, Pieter-Jan de KamORCiD |
---|
URN: | urn:nbn:de:hebis:30:3-544921 |
---|
DOI: | https://doi.org/10.1016/j.waojou.2019.100075 |
---|
ISSN: | 1939-4551 |
---|
Parent Title (English): | World Allergy Organization journal |
---|
Publisher: | Wolters Kluwer Health Lippincott Williams & Wilkins |
---|
Place of publication: | Hagerstown, Md. |
---|
Document Type: | Article |
---|
Language: | English |
---|
Year of Completion: | 2019 |
---|
Date of first Publication: | 2019/10/25 |
---|
Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
---|
Release Date: | 2020/04/22 |
---|
Tag: | Allergen immunotherapy; Allergoid; Cumulative dose; Curvilinear dose response; Grass pollen |
---|
Volume: | 12 |
---|
Issue: | 11, Art. 100075 |
---|
Page Number: | 14 |
---|
First Page: | 1 |
---|
Last Page: | 14 |
---|
Note: | This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
---|
HeBIS-PPN: | 46618543X |
---|
Institutes: | Medizin / Medizin |
---|
Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
---|
Sammlungen: | Universitätspublikationen |
---|
Licence (German): | Creative Commons - Namensnennung-Nicht kommerziell - Keine Bearbeitung 4.0 |
---|