Introduction PQ Grass 27600SU is a modified broad spectrum grass allergen subcutaneous immunotherapy (SCIT) product using MicroCrystalline Tyrosine (MCT) & Monophosphoryl Lipid A (MPL) as adjuvant system. 2 highly comparable randomised double-blind, placebo-controlled field studies with PQ Grass 27600SU have been recently completed to support a marketing authorisation application. Here, we report on the integrated primary endpoint results using a meta-analysis approach.

Methods A common effects meta-analysis was applied and justified due to the similarity of study designs, study populations, primary endpoint definitions (i.e. the combined symptom and medication score (CSMS)) and statistical analysis methods. These were the only 2 field studies performed with the same optimized cumulative dose of PQ Grass 27600SU, both conducted to evaluate efficacy & safety of PQ Grass 27600SU in patients (18 to 65 years of age incl.) with seasonal allergic rhinitis due to grass pollen.

Results In total 674 subjects with allergic conjunctivitis and/or rhinitis were included in this meta-analysis. The homogeneity of the data for the meta-analysis approach was also statistically confirmed (heterogeneity test p=0.21). The results of this meta-analysis showed a clinically relevant and highly statistically significant treatment effect for the primary endpoint CSMS during the the peak grass pollen season.

Discussion PQ Grass 27600SU is an innovative short-course allergen-specific SCIT product with a potent adjuvant system. The 2 field studies with PQ Grass 27600SU included in the meta-analysis were highly comparable and demonstrated a clinically relevant & statistically significant integrated primary endpoint result, supporting marketing authorisation application of PQ Grass 27600SU.

The study is funded by Allergy Therapeutics Ltd. The authors are either contracted for the study by Allergy Therapeutics (SB, SZ) or employees of Allergy Therapeutics (PJK, MFK, MAS, FS).