title: Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults.
abstract: BACKGROUND
  In North America and Europe, millions of patients experience symptoms of allergic rhinitis with or without conjunctivitis (AR/C) on exposure to ragweed pollen. The disease burden can be significant, with most patients relying on symptomatic medications without disease-modifying potential. However, novel sublingual immunomodulatory treatment options may potentially play an important role if efficacy and side effect profiles allow the convenience of self-administration.
  
  
  OBJECTIVE
  This study evaluated an allergy immunotherapy tablet (AIT; SCH 39641/MK-3641) for treatment of ragweed-induced AR/C in the first large randomized, double-blind multinational trial of this therapeutic modality for ragweed allergy.
  
  
  METHODS
  Adults (n = 784) with short ragweed-induced AR/C were randomly assigned to approximately 52 weeks of daily self-administered ragweed AIT of 1.5, 6, or 12 units of Ambrosia artemisiifolia major allergen 1 (Amb a 1-U) or placebo. Subjects could use as-needed allergy rescue medication. Symptoms and medications were recorded daily. The primary efficacy end point was total combined daily symptom/medication score (TCS) during peak ragweed season. Safety was monitored through adverse event diaries maintained through study duration.
  
  
  RESULTS
  During peak ragweed season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 9% (-0.76; P = .22), 19% (-1.58; P = .01), and 24% (-2.04; P = .002) compared with placebo. During the entire season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 12% (-0.88; P = .09), 18% (-1.28; P = .01), and 27% (-1.92; P < .001) compared with placebo. Treatment was well tolerated; no systemic allergic reactions occurred.
  
  
  CONCLUSIONS
  In this trial, ragweed AIT of 12 Amb a 1-U was effective and tolerable with a safety profile that permitted daily self-administration of ragweed allergen immunotherapy.
authors.affiliation: Division of Allergy and Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, MD 21224-6801, USA. psocrates@comcast.net
authors.forename: Peter S
authors.initials: PS
authors.lastname: Creticos
authors.forename: Jennifer
authors.initials: J
authors.lastname: Maloney
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: Thomas
authors.initials: T
authors.lastname: Casale
authors.forename: Amarjot
authors.initials: A
authors.lastname: Kaur
authors.forename: Robert
authors.initials: R
authors.lastname: Fisher
authors.forename: Nancy
authors.initials: N
authors.lastname: Liu
authors.forename: Kevin
authors.initials: K
authors.lastname: Murphy
authors.forename: Kristóf
authors.initials: K
authors.lastname: Nékám
authors.forename: Hendrik
authors.initials: H
authors.lastname: Nolte
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D000485:Allergens / Q000008:administration & dosage; D031164:Ambrosia / Q000009:adverse effects / Q000276:immunology; D052179:Antigens, Plant / Q000008:administration & dosage* / Q000009:adverse effects; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000276:immunology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010940:Plant Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D011058:Pollen / Q000009:adverse effects; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy*; D012646:Self Administration; D013607:Tablets
chemical_list: D000485:Allergens; C026967:Amb a I protein, Ambrosia artemisiifolia; D052179:Antigens, Plant; D010940:Plant Proteins; D013607:Tablets