Short course of grass allergen peptides immunotherapy over 3weeks reduces seasonal symptoms in allergic rhinoconjunctivitis with/without asthma: A randomized, multicenter, double-blind, placebo-controlled trial

BackgroundImmunotherapy 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 170g LPP administered subcutaneously over 3weeks. MethodsIn 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 170g LPP administered in increasing doses in 4 visits over 3weeks. 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. ResultsThe 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 30minutes 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. ConclusionLolium perenne pollen peptides administered over 3weeks before the grass pollen season significantly reduced seasonal symptoms and was generally safe and well-tolerated.