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Induction of Local and Systemic Blocking Antibodies by PQ Grass 27600 SU for the Treatment of Seasonal Allergic Rhinitis: A RDBPC Pilot Study

2023; Elsevier BV; Volume: 151; Issue: 2 Linguagem: Inglês

10.1016/j.jaci.2022.12.744

1097-6825

Mohamed H. Shamji, Janice A. Layhadi, Anna Cutrina Pons, Lily Wu, Sviatlana Starchenka, Olesya Rusyn, Oliver Armfield, Katarzyna Lis, Kemi Oluwayi, Matthias Kramer, Matthew D. Heath, Murray Skinner, Pieter‐Jan de Kam,

Allergic Rhinitis and Sensitization

PQ Grass, a grass pollen allergoid using MicroCrystalline Tyrosine and Monophosphoryl Lipid A as an adjuvant system, is a well-tolerated subcutaneous immunotherapy for seasonal allergic rhinitis. We hypothesised that PQ Grass 27600 SU is effective in inducing functional allergen-specific blocking antibodies. In this study participants either received PQ Grass (conventional or extended posology) or placebo. Sera and nasal fluid were collected at baseline (V1), prior (V12) and post (V15) grass pollen season. Grass pollen specific IgA1, IgA2, IgG and IgG4 were measured. Blocking antibodies were measured using IgE-facilitated allergen binding assay (IgE-FAB). PQ Grass demonstrated a clinically relevant (conventional posology -33.1%; extended posology -39.5%) and significant treatment effect for the combined symptom and medication score compared to placebo (P<0.05). Systemic sIgG and local sIgG, sIgG4 was significantly induced at V12 and V15 in both posologies, compared to V1 (P<0.001) and placebo (P<0.05). Systemic sIgA1 and sIgA2 was increased at V12 and V15 (P<0.001) in both AIT posologies compared to V1 (P<0.001) and placebo. Allergen-IgE complexes binding to B cells were significantly decreased in serum at V12 and V15 (P<0.05) and in nasal fluid at V15 (P<0.01) compared to V1 in both posologies, but not placebo. Level of serum and nasal sIgG4 and serum IgA2 correlated with IgE-FAB (r=-0.39, P<0.001; r=-0.34, P<0.01; r=-0.42, P<0.001, respectively) in the extended AIT posology. PQ Grass 27600 SU induces local and systemic blocking antibodies that can inhibit the formation of allergen-IgE complexes and their binding to B cells, making them reliable surrogate biomarkers of efficacy.