title: Efficacy and safety of D. pteronyssinus immunotherapy in local allergic rhinitis: a double-blind placebo-controlled clinical trial.
abstract: The effects of allergen immunotherapy (AIT) on local allergic rhinitis (LAR) are largely unknown. We conducted the first randomized, double-blind, placebo-controlled (DBPC), phase II trial of D. pteronyssinus (DP) subcutaneous AIT (DP-AIT) on LAR (clinicaltrials.gov identifier: NCT02123316). Thirty-six LAR patients received Pangramin PLUS DP or placebo for 24 months. The primary endpoints were symptoms, medication scores, and medication-free days. The secondary included skin test, serum specific IgE and IgG4, nasal allergen provocation test (NAPT), and adverse events. AIT-DP produced significant improvements in both primary and secondary endpoints vs placebo. After 12 months of AIT-DP, we detected a significant and marked increase in allergen tolerance with negative NAPT in 50% of patients, and significant increases of serum sIgG4. Immunotherapy was well tolerated; no systemic reactions were reported. This study demonstrated that AIT-DP is a safe and clinically effective treatment for LAR, confirming that LAR is a new indication for AIT.
authors.affiliation: Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Rondón
authors.affiliation: Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Campo
authors.affiliation: Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Salas
authors.affiliation: Research Laboratory-Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Aranda
authors.affiliation: Research Laboratory-Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Molina
authors.affiliation: Research Laboratory-Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: M
authors.initials: M
authors.lastname: González
authors.affiliation: Research Laboratory-Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: L
authors.initials: L
authors.lastname: Galindo
authors.affiliation: Research Laboratory-Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Mayorga
authors.affiliation: Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: M J
authors.initials: MJ
authors.lastname: Torres
authors.affiliation: Allergy Unit, IBIMA-Regional University Hospital of Málaga, UMA, Malaga, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Blanca
mesh_terms: D000485:Allergens / Q000008:administration & dosage / Q000276:immunology*; D000818:Animals; D039741:Antigens, Dermatophagoides / Q000008:administration & dosage / Q000276:immunology*; D040002:Dermatophagoides pteronyssinus / Q000276:immunology*; D003888:Desensitization, Immunologic / Q000379:methods; D006801:Humans; D065631:Rhinitis, Allergic / Q000276:immunology* / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D000485:Allergens; D039741:Antigens, Dermatophagoides
keywords: allergen immunotherapy; clinical effect; house dust mite; immunological response; local allergic rhinitis