Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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SHR Neuro Krebs Kardio Lipid Stoffw Microb
Zielen, S; Kuna, P; Aberer, W; Lassmann, S; Pfaar, O; Klimek, L; Wade, A; Kluehr, K; Raab, J; Wessiepe, D; Lee, D; Kramer, MF; Gunawardena, K; Higenbottam, T; Heath, MD; Skinner, MA; de Kam, PJ.
Strong dose response after immunotherapy with PQ grass using conjunctival provocation testing.
World Allergy Organ J. 2019; 12(11):100075-100075
Doi: 10.1016/j.waojou.2019.100075
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- Co-Autor*innen der Med Uni Graz
- Aberer Werner
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- Abstract:
- 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. 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. 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. PQ Grass demonstrated a strong curvilinear dose response in TSS following CPT without compromising its safety profile. © 2019 The Author(s).
- Find related publications in this database (Keywords)
- Allergen immunotherapy
- Allergoid
- Cumulative dose
- Curvilinear dose response
- Grass pollen