Efficacy of short-course PQ grass subcutaneous treatment for grass allergy

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Created On: 29/09/2023

A double-blind, randomized, exploratory, placebo-controlled trial aimed to assess the combined symptom and medication score (CSMS) of an optimized cumulative dosage of Pollinex Quattro (PQ) grass (27,600 standardized units [SU]), preceding the Phase III trial, under field setting.

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Key take away

A short course subcutaneous treatment using Pollinex Quattro grass remarkably enhances symptom and medication scores in individuals suffering from grass allergy.

Background

Method

Participants were recruited from 14 locations spanning the United States of America and Germany. A total of 119 individuals, aged 18 to 65 years, with moderate-to-severe seasonal allergic rhinitis (SAR) with or without well-managed asthma, were selected for the study. These participants received either conventional or extended PQ grass subcutaneous injections, or a placebo, encompassing a total of six pre-seasonal injections.

During peak grass pollen season (GPS), CSMS was the major effectiveness outcome of the study. Allergen-specific immunoglobulin G4 (IgG4) response and rhinoconjunctivitis quality of life questionnaire standardized (RQLQ-S) were the secondary outcomes ascertained.

Result

In relation to the placebo group, the mean CSMS values for the standard and extended treatment plans are depicted in Table1:

Both regimens resulted in elevated levels of IgG4, and the extended regimen exhibited a betterment in total RQLQ-S (mean change of -0.72). Moreover, both approaches had good tolerability.

Conclusion

This study revealed a meaningful and statistically significant effectiveness response to PQ grass. After just six injections, remarkable effect sizes of approximately/almost equal to 40% in comparison with placebo were achieved for CSMS in grass allergy patients.

Both schedules of PQ grass treatment were regarded as equally well-tolerated and safe. Due to the improved effectiveness profile, the extended regimen will advance to the pivotal Phase III trial.