title: Adverse reactions and tolerability of high-dose sublingual allergen immunotherapy.
abstract: BACKGROUND
  Sublingual allergen immunotherapy is an effective treatment against allergic respiratory disease. Many studies have shown the safety of this type of therapy, although the factors that might affect the tolerability of high-dose sublingual immunotherapy have not been well established. The aim of this study was to determine the factors that affect the tolerability of sublingual allergen immunotherapy.
  
  
  METHODS
  A total of 183 subjects aged ≥5 years, diagnosed with allergic rhinitis with/without mild to moderate asthma due to sensitization to grass, olive pollen, or mites, were included in this open, retrospective, multicentric, noninterventional study. Sublingual immunotherapy was administered for at least 3 months.
  
  
  RESULTS
  The most frequent adverse reaction was oral pruritus (13.7% of the patients). Most of the reactions were local (84.7%) and immediate (93.5%) and occurred during the initiation phase (60.6%). All reactions were mild to moderate in severity. No serious adverse reactions were registered. When comparing factors with potential influence on the occurrence of adverse reactions, the results between the groups of subjects with and without adverse reactions showed no statistically significant differences in sex (P=0.6417), age (P=0.1801), years since the disease was first diagnosed (P=0.3800), treatment composition (P=0.6946), polysensitization (P=0.1730), or clinical diagnosis (P=0.3354). However, it was found that treatment duration had a statistically significant influence (3 months, >3 months: P=0.0442) and the presence of asthma was close to statistical significance (P=0.0847).
  
  
  CONCLUSIONS
  In our study, treatment duration is significantly associated with the occurrence of adverse reactions after the administration of high doses of sublingual allergen immunotherapy.
authors.affiliation: Allergy Service, Hospital Virgen del Valle, Toledo.
authors.forename: Angel
authors.initials: A
authors.lastname: Moral
authors.affiliation: Allergy Service, Hospital Blanca Paloma, Huelva.
authors.forename: Victoria
authors.initials: V
authors.lastname: Moreno
authors.affiliation: Consulta Privada, Granada.
authors.forename: Francisco
authors.initials: F
authors.lastname: Girón
authors.affiliation: Allergy Service, Clínica Atenea, Castellón.
authors.forename: David
authors.initials: D
authors.lastname: El-Qutob
authors.affiliation: Pediatric Department, Complejo Hospitalario Universitario de Santiago, A Coruña.
authors.forename: José D
authors.initials: JD
authors.lastname: Moure
authors.affiliation: Allergy Service, Complejo Hospitalario de Jaén, Jaén.
authors.forename: Manuel
authors.initials: M
authors.lastname: Alcántara
authors.affiliation: Allergy Service, Hospital Infanta Sofía, Madrid.
authors.forename: Antonia
authors.initials: A
authors.lastname: Padial
authors.affiliation: Centro de Alergia y Asma Balear, Mallorca.
authors.forename: Alberto G
authors.initials: AG
authors.lastname: Oehling
authors.affiliation: Consulta Privada, Cádiz.
authors.forename: Carmen
authors.initials: C
authors.lastname: Millán
authors.affiliation: ALK-Abelló, SA, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: de la Torre
keywords: Dermatophagoides pteronyssinus; Olea europaea; allergic rhinitis; grass; sublingual immunotherapy; tolerability