Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy
allergic rhinoconjunctivitis; grass pollen allergy; short-course treatment; subcutaneous immunotherapy
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.
de Kam, P J.; Zielen, S; Bernstein, J A.; Berger, U; Berger, M; Cuevas, M; Cypcar, D; Fuhr-Horst, A; Greisner, W A.; Jandl, M; Laßmann, S; Worm, M; Matz, J; Sher, E; Smith, C; Steven, G C.; Mösges, R; Shamji, M H.; DuBuske, L; Borghese, F; Oluwayi, K; Zwingers, T; Seybold, M; Armfield, O; Heath, M D.; Hewings, S J.; Kramer, M F.; and Skinner, M A., "Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy" (2023). GW Authored Works. Paper 2682.