Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy
Research output: Contribution to journal › Research article › Contributed › peer-review
Contributors
Abstract
Background: A modified grass allergen subcutaneous immunotherapy (SCIT) product with MicroCrystalline Tyrosine and monophosphoryl lipid-A as an adjuvant system (Grass MATA MPL [PQ Grass]) is being developed as short-course treatment of grass-pollen allergic rhinitis (SAR) and/or rhinoconjunctivitis. We sought to evaluate the combined symptom and medication score (CSMS) of the optimized cumulative dose of 27,600 standardized units (SU) PQ Grass in a field setting prior to embarking on a pivotal Phase III trial. Methods: In this exploratory, randomized, double-blind, placebo-controlled trial subjects were enrolled across 14 sites (Germany and the United States of America). Six pre-seasonal subcutaneous injections of PQ Grass (using conventional or extended regimens) or placebo were administered to 119 subjects (aged 18–65 years) with moderate-to-severe SAR with or without asthma that was well-controlled. The primary efficacy endpoint was CSMS during peak grass pollen season (GPS). Secondary endpoints included Rhinoconjunctivitis Quality of Life Questionnaire standardized (RQLQ-S) and allergen-specific IgG4 response. Results: The mean CSMS compared to placebo was 33.1% (p =.0325) and 39.5% (p =.0112) for the conventional and extended regimens, respectively. An increase in IgG4 was shown for both regimens (p <.01) as well as an improvement in total RQLQ-S for the extended regimen (mean change −0.72, p =.02). Both regimens were well-tolerated. Conclusions: This trial demonstrated a clinically relevant and statistically significant efficacy response to PQ Grass. Unprecedented effect sizes were reached for grass allergy of up to ≈40% compared to placebo for CSMS after only six PQ Grass injections. Both PQ Grass regimens were considered equally safe and well-tolerated. Based on enhanced efficacy profile extended regime will be progressed to the pivotal Phase III trial.
Details
Original language | English |
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Pages (from-to) | 2756-2766 |
Number of pages | 11 |
Journal | Allergy: European Journal of Allergy and Clinical Immunology |
Volume | 78 |
Issue number | 10 |
Publication status | Published - Oct 2023 |
Peer-reviewed | Yes |
External IDs
PubMed | 37366581 |
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Keywords
ASJC Scopus subject areas
Keywords
- allergic rhinoconjunctivitis, grass pollen allergy, short-course treatment, subcutaneous immunotherapy