title: Post-marketing survey on the safety of sublingual immunotherapy in children below the age of 5 years.
abstract: BACKGROUND
  The age below 5 years is considered a prudential limit for immunotherapy in view of the possible severity of side-effects. Sublingual immunotherapy (SLIT) seems to be safe, but no study in very young children is available. We performed a safety post-marketing surveillance study in children below 5 years.
  
  
  METHODS
  Children aged 3-5 years with respiratory allergy receiving SLIT were followed-up for at least 2 years. A diary card for side-effects was filled by parents at each dose given. Local and systemic side-effects were graded as: mild (no intervention, no dose adjustment), moderate (medical treatment and/or dose reduction), severe (life-threatening/hospitalization/emergency care). The comparative safety of different allergens and regimens was also assessed.
  
  
  RESULTS
  One hundred and twenty-six children (mean age 4.2 years, 67 male) were included. Seventy-six (60%) had rhinitis with asthma, 34 (27%) rhinitis only and 16 (13%) only asthma. Immunotherapy was prescribed for mites (62%), grasses (22.2%), Parietaria (11.9%), Alternaria (2.4%) and olive (1.5%). Eighteen children underwent an accelerated build-up. The total number of doses was about 39,000. Nine side-effects were reported in seven children (5.6% patients and 0.2/1000 doses). Two episodes of oral itching and one of abdominal pain were mild. Six gastrointestinal side-effects were controlled by reducing the dose. All side-effects occurred during up-dosing phase. No difference in terms of safety among the allergens used was observed.
  
  
  CONCLUSIONS
  SLIT is safe also in children under the age of 5 years.
authors.affiliation: Clinica Villa Benedetta, Rome, Italy.
authors.forename: V Di
authors.initials: VD
authors.lastname: Rienzo
authors.forename: M
authors.initials: M
authors.lastname: Minelli
authors.forename: A
authors.initials: A
authors.lastname: Musarra
authors.forename: R
authors.initials: R
authors.lastname: Sambugaro
authors.forename: S
authors.initials: S
authors.lastname: Pecora
authors.forename: W G
authors.initials: WG
authors.lastname: Canonica
authors.forename: G
authors.initials: G
authors.lastname: Passalacqua
mesh_terms: D000286:Administration, Sublingual; D000485:Allergens / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D000528:Alternaria / Q000276:immunology; D001249:Asthma / Q000276:immunology / Q000628:therapy; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016233:Immunotherapy, Active / Q000009:adverse effects / Q000379:methods*; D008297:Male; D032403:Parietaria / Q000276:immunology; D011358:Product Surveillance, Postmarketing / Q000379:methods; D039981:Pyroglyphidae / Q000276:immunology; D012130:Respiratory Hypersensitivity / Q000276:immunology / Q000628:therapy*; D012220:Rhinitis / Q000276:immunology / Q000628:therapy
chemical_list: D000485:Allergens