Specific Immunotherapy in LAR: a randomized, double-blind placebo controlled trial with Phleum pratense subcutaneous allergen immunotherapy

Abstract

Background

Allergen immunotherapy has been shown to be an effective treatment for local allergic rhinitis (LAR) to house dust mites. Studies with pollen allergen immunotherapy are limited to observational studies. The aim of this study was to evaluate the clinical efficacy and safety of Phleum pratense subcutaneous immunotherapy (Phl-SCIT) in LAR.

Methods

In a randomized double-blind placebo-controlled study, 56 patients with moderate-severe LAR to grass pollen received Phl-SCIT with a depigmented-polymerized pollen vaccine or placebo for the first year, and Phl-SCIT the second one. The blind was maintained throughout the study. Primary outcome was combined symptoms-medication score (CSMS) during grass pollen season (GPS). Secondary clinical outcomes included organ-specific symptoms, medication free days, rhinitis severity, and asthma control. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal allergen provocation test (NAPT), skin testing, serum levels of specific-IgG4 and specific-IgE, and safety were also evaluated.

Results

SCIT had a short-term and sustained effect with significant improvements of all primary and secondary clinical outcomes and RQLQ score. SCIT significantly increased serum sIgG4 levels and allergen tolerance, from the 6^th to 24^th months of treatment. At the end of the study 83% of patients treated with ≥6 months of SCIT tolerated a concentration of Phl over 50 times higher than baseline, and 56% gave a negative NAPT. SCIT was well-tolerated; six mild local reactions occurred, and there were no serious adverse events related to the study medication.

Conclusions

Subcutaneous immunotherapy with depigmented-polymerized allergen extracts is a safe and clinically effective treatment for LAR to Phleum pratense.clinicaltrials. gov identifier: NCT02126111.

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