title: Safety of various dosage regimens during induction of sublingual immunotherapy. A preliminary study.
abstract: BACKGROUND
  Sublingual immunotherapy (SLIT) has been demonstrated to be a viable alternative to injection immunotherapy. Administration of high doses of allergens to ensure efficacy has been shown to be well tolerated. The aim of the present study was the first step to address the issue of fast-induction regimens using various induction SLIT regimens in paediatric and adult patients.
  
  
  METHODS
  Sixty-four patients (age range 5-46 years) with grass pollen rhinoconjunctivitis were enrolled in an 8-month double-blind, placebo-controlled trial of SLIT. Sixty-three patients were randomized to four groups and evaluated at the end of the study. One group received placebo (n = 16) and the other three groups (n = 47) received five grass pollen extracts according to three different induction regimens: regimen 1 starting with 3 IR tablets (n = 15), regimen 2 starting with 10 IR (n = 16) and regimen 3 starting with 30 IR (n = 16). The maintenance phase was made with sublingual-swallow drops at the same concentration of 300 IR/ml for all the patients. Adverse events were recorded on diary cards.
  
  
  RESULTS
  During induction phase, 25/47 patients in the SLIT groups had adverse reactions in comparison to 2/16 patients in the placebo group (p < 0.05). The rate of adverse reactions was 33.3% (11.8-61.6) (95% CI) for regimen 1, 31.3% (11.0-58.7) for regimen 2, 43.8% (19.8-70.1) for regimen 3 and 12.5% (1.6-38.3) for placebo. Fifty-seven reactions were local reactions involving the oral region (54 SLIT, 3 placebo) and 13 were systemic reactions (all in the SLIT groups). 11/13 reactions were mild (gastrointestinal disorders, rhinoconjunctivitis), 1/13 consisted of moderate asthma and 1/13 consisted of severe abdominal pain. No urticaria, angioedema or life-threatening events were observed.
  
  
  CONCLUSIONS
  These preliminary data showed that various induction regimens for SLIT are generally well tolerated and could allow a fast build-up phase of SLIT.
authors.affiliation: Guilleret-Granges, France.
authors.forename: M
authors.initials: M
authors.lastname: Grosclaude
authors.forename: P
authors.initials: P
authors.lastname: Bouillot
authors.forename: R
authors.initials: R
authors.lastname: Alt
authors.forename: F
authors.initials: F
authors.lastname: Leynadier
authors.forename: P
authors.initials: P
authors.lastname: Scheinmann
authors.forename: P
authors.initials: P
authors.lastname: Rufin
authors.forename: D
authors.initials: D
authors.lastname: Basset
authors.forename: R
authors.initials: R
authors.lastname: Fadel
authors.forename: C
authors.initials: C
authors.lastname: André
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003429:Cross Reactions / Q000187:drug effects / Q000276:immunology; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004342:Drug Hypersensitivity / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D012449:Safety; D012720:Severity of Illness Index; D016896:Treatment Outcome