title: Efficacy and safety of sublingual immunotherapy with grass monomeric allergoid: comparison between two different treatment regimens.
abstract: BACKGROUND
  Sublingual immunotherapy (SLIT) with monomeric carbamylated allergoid proved to be well tolerated, safe and effective in patients with respiratory allergy. Standard administration regimens are expected to require a long time before clinical benefit can be appreciated. We investigated whether pre-seasonal and perennial regimens differently affect the clinical efficacy of grass pollen SLIT.
  
  
  METHODS
  Adult patients with allergic rhino-conjunctivitis with/without mild intermittent asthma due to grass pollen were included into this open prospective study and randomised to receive SLIT with a continuous regimen (Group 1: 1,000 AU/week for the entire study period) or a pre-seasonal regimen (Group 2: 5,000 AU/week for 10 weeks/year for 2 years), or on demand drug therapy alone (Group 3) for two years. At entry (November 2005), at the end of the first and second pollen season, a Visual Analogue Scale (VAS) was used to assess patients' well-being. Symptom score and drug consumption were evaluated during the seasons. Methacholine challenge was performed at study entry and conclusion. Adverse events were recorded along the whole study duration.
  
  
  RESULTS
  Thirty-two patients were divided into Group 1 (n = 10), Group 2 (n = 11) and Group 3 (n = 11). A significant VAS improvement was observed in both SLIT groups, after the first and second pollen season, compared to baseline and to Group 3 (p < 0.05). Less symptoms and need for medications resulted during the second season (p < 0.05). No relevant variations in bronchial hyper-reactivity have been observed between the three groups. Only 2 patients experienced local or mild reactions in SLIT groups.
  
  
  CONCLUSIONS
  Both pre-seasonal and continuous regimen of SLIT with monomeric allergoid turned out effective and safe, suggesting that a pre-seasonal course with 5,000 AU/week for 10 weeks may represent a convenient option in patients with grass pollen allergic rhinitis with/without mild intermittent asthma. Further research is urgently needed to consolidate these preliminary evidences.
authors.affiliation: Allergological Department, U.O. Medicina, Presidio Ospedaliero di Faenza (RA), Italy.
authors.forename: O
authors.initials: O
authors.lastname: Quercia
authors.forename: M E
authors.initials: ME
authors.lastname: Bruno
authors.forename: E
authors.initials: E
authors.lastname: Compalati
authors.forename: P
authors.initials: P
authors.lastname: Falagiani
authors.forename: G
authors.initials: G
authors.lastname: Mistrello
authors.forename: G F
authors.initials: GF
authors.lastname: Stefanini
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D000368:Aged; D000080384:Allergoids; D052179:Antigens, Plant / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D001249:Asthma / Q000628:therapy*; D002219:Carbamates / Q000737:chemistry; D002985:Clinical Protocols; D003233:Conjunctivitis, Allergic / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000379:methods*; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D016210:Methacholine Chloride / Q000008:administration & dosage; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D006109:Poaceae / Q000276:immunology; D011446:Prospective Studies; D006255:Rhinitis, Allergic, Seasonal / Q000628:therapy*; D012621:Seasons; D016896:Treatment Outcome
chemical_list: D000080384:Allergoids; D052179:Antigens, Plant; D002219:Carbamates; D010936:Plant Extracts; D016210:Methacholine Chloride