D2.176 - Improved quality of life after PQ Grass in comparison to SLIT products in grass allergic patients

PQ Grass 27600 SU is a short-course, aluminium-free, modified subcutaneous immunotherapy (SCIT) product for treatment of seasonal allergic rhinitis (AR). Two randomised double-blind, placebo-controlled field studies with PQ Grass were recently completed with positive primary and secondary results. To assess the relevance of the improvement in rhinoconjunctivitis quality of life questionnaire score (RQLQ[S]) achieved with PQ Grass, a comparison was made to Phase III RQLQ[S] results of two registered sublingual immunotherapy (SLIT) products.

For PQ Grass a meta-analysis approach was applied where the RQLQ[S] results of the single study analyses were combined, and a common effects data integration was performed, using weights determined by study size. For the SLIT Phase III studies the total treatment effect size and 95% CIs were derived using an integrated analysis approach, based on effect sizes and 95% CI’s from published Phase III studies, weighing results based on study size.

The PQ Grass G309 and G306 trials demonstrated large and statistically significant improvements in RQLQS[S] after PQ Grass compared to placebo, −0.72 points (−37.9%, p=0.02) and -0.49 points (-27.5%, p=0.0001), respectively. The meta-analysis of PQ Grass demonstrated an overall improvement in RQLQ[S] of -0.51 points (- 28.9%, p<0.00001). An average RQLQ[S] improvement of -0.20 and –0.32 points was calculated for the single-grass and five-grass SLIT tablets compared to placebo, respectively.

PQ Grass 27600 SU is an innovative short-course adjuvanted SCIT product, which demonstrated a clinically meaningful improvement in rhinitis quality of life after PQ Grass compared to placebo in two field clinical trials. When using a pooled Phase III data approach, short-course PQ Grass injections achieved an approximately 2-fold more pronounced improvement in RQLQ(S) compared to registered grass SLIT products with daily tablet intake.