TY  - JOUR
A1  - Zielen, Stefan
A1  - Kuna, Piotr
A1  - Aberer, Werner
A1  - Laßmann, Sabine
A1  - Pfaar, Oliver
A1  - Klimek, Ludger
A1  - Wade, Anette
A1  - Kluehr, Karolin
A1  - Raab, Jennifer
A1  - Wessiepe, Dorothea
A1  - Lee, Denise
A1  - Kramer, Matthias F.
A1  - Gunawardena, Kulasiri
A1  - Higenbottam, Timothy
A1  - Heath, Matthew D.
A1  - Skinner, Murray A.
A1  - Kam, Pieter-Jan de
T1  - Strong dose response after immunotherapy with PQ grass using conjunctival provocation testing
T2  - World Allergy Organization journal
N2  - 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.
KW  - Allergen immunotherapy
KW  - Allergoid
KW  - Cumulative dose
KW  - Curvilinear dose response
KW  - Grass pollen
Y1  - 2019
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/54492
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-544921
SN  - 1939-4551
N1  - This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
VL  - 12
IS  - 11, Art. 100075
SP  - 1
EP  - 14
PB  - Wolters Kluwer Health Lippincott Williams & Wilkins
CY  - Hagerstown, Md.
ER  -