title: Efficacy and safety of oral immunotherapy with short ragweed extract.
abstract: BACKGROUND
  Oral immunotherapy, if proven safe and effective, could be an alternative to subcutaneous immunotherapy.
  
  
  OBJECTIVE
  This pilot study investigated the clinic and immunologic effects of ragweed immunotherapy using a new microencapsulated, pH-sensitive, oral delivery system.
  
  
  METHODS
  A double-blind, placebo-controlled trial was conducted in 23 patients with allergic rhinitis to short ragweed. Following a baseline nasal challenge with ragweed allergen, oral immunotherapy with encapsulated short ragweed extract or placebo was administered once daily, 6 days/week. Dosed began at 3 micrograms Amb a 1 per day and were increased by 3 micrograms every three days as tolerated, to a maximum daily maintenance dose of 24 micrograms. A nasal challenge was repeated 6 weeks, later, followed by the continuation of maintenance therapy through the natural ragweed season. Daily allergy symptoms and relief medication usage was recorded. A final nasal challenge was performed at the end of the natural season. Short ragweed-specific serum IgE, IgG, and IgG4 antibody levels were measured every 2 weeks during the study.
  
  
  RESULTS
  Maximum tolerated doses ranged from 6 to 24 micrograms Amb a 1 per day (74% reached 24 micrograms). Adverse events were not serious or different between the active and placebo groups. The active group showed increased in short ragweed-specific serum IgG and IgG4 antibody levels. Symptom scores during the natural season were numerically but not statistically lower in the active treatment group. This group also experienced a greater reduction from baseline in nasal reactivity as assessed by nasal challenge.
  
  
  CONCLUSIONS
  These pilot data suggest that the encapsulated, pH-sensitive oral immunotherapy delivery system was safe, induced a brisk serologic response, and attenuated the symptomatic response to both experimental and environmental ragweed exposure.
authors.affiliation: Children's Hospital of Pittsburgh Pennsylvania, USA.
authors.forename: M A
authors.initials: MA
authors.lastname: Van Deusen
authors.forename: B L
authors.initials: BL
authors.lastname: Angelini
authors.forename: K M
authors.initials: KM
authors.lastname: Cordoro
authors.forename: B A
authors.initials: BA
authors.lastname: Seiler
authors.forename: L
authors.initials: L
authors.lastname: Wood
authors.forename: D P
authors.initials: DP
authors.lastname: Skoner
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000485:Allergens; D052179:Antigens, Plant; D004306:Dose-Response Relationship, Immunologic; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D007167:Immunotherapy / Q000379:methods* / Q000592:standards; D009299:Nasal Provocation Tests; D010940:Plant Proteins / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D011058:Pollen / Q000276:immunology; D012129:Respiratory Function Tests; D013223:Statistics as Topic
chemical_list: D000485:Allergens; C028564:Amb a III protein, Ambrosia artemisiifolia; D052179:Antigens, Plant; D007074:Immunoglobulin G; D010940:Plant Proteins; D007073:Immunoglobulin E