BACKGROUND: Immunotherapy with peptide hydrolysates from Lolium perenne (LPP) is an alternative treatment for seasonal allergic rhinitis with or without asthma. The aim of this study was to assess the clinical efficacy and safety of a cumulative dose of 170 μg LPP administered subcutaneously over 3 weeks. METHODS: In a randomized, double-blind, placebo-controlled trial, 554 adults with grass pollen rhinoconjunctivitis were randomized (1:2 ratio) to receive 8 subcutaneous injections of placebo or 170 μg LPP administered in increasing doses in 4 visits over 3 weeks. The primary outcome was the combined symptom and medication score (CSMS) measured over the peak pollen season. Reactivity to conjunctival provocation test (CPT) and quality of life (QOL) was assessed as secondary endpoints. RESULTS: The mean reduction in CSMS in the LPP vs placebo group was -15.5% (P = .041) during the peak period and -17.9% (P = .029) over the entire pollen season. LPP-treated group had a reduced reactivity to CPT (P < .001) and, during the pollen season, a lower rhinoconjunctivitis QOL global score (P = .005) compared with placebo group. Mostly mild and WAO grade 1 early systemic reaction (ESR) were observed ≤30 minutes in 10.5% of LPP-treated patients, whereas 3 patients with a medical history of asthma (<1%) experienced a serious ESR that resolved with rescue medication. CONCLUSION: Lolium perenne pollen peptides administered over 3 weeks before the grass pollen season significantly reduced seasonal symptoms and was generally safe and well-tolerated.

ASIT Biotech Brussels Belgium

Center for Rhinology and Allergology Wiesbaden Germany

Department of Immunology and Allergology Faculty of Medicine and Faculty Hospital in Pilsen Charles University Prague Pilsen Czech Republic

Department of Otorhinolaryngology Head and Neck Surgery Universitätsmedizin Mannheim Medical Faculty Mannheim Heidelberg University Mannheim Germany

Freelance Biostatistics Consultant Waterloo Belgium

Immune Tolerance Group Allergy and Clinical Immunology Inflammation Repair and Development NHLI Imperial College London MRC Asthma UK Centre UK

Institute of Medical Statistics Informatics and Epidemiology Cologne Germany

Upper Airways Research Laboratory Ghent University Hospital Ghent Belgium

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Biomarkers for diagnosis and prediction of therapy responses in allergic diseases and asthma