title: Sequential Treatment Initiation with Timothy Grass and Ragweed Sublingual Immunotherapy Tablets Followed by Simultaneous Treatment Is Well Tolerated.
abstract: BACKGROUND
  Dual treatment with grass and ragweed sublingual immunotherapy (SLIT) tablets has not been studied.
  
  
  OBJECTIVE
  To characterize the safety and tolerability of dual grass and ragweed SLIT-tablet administration.
  
  
  METHODS
  This open-label, multicenter trial (NCT02256553) enrolled North American adults (N = 102) allergic to grass and ragweed. The trial had 3 periods, each of 2 weeks duration. In period 1, subjects received once-daily timothy grass SLIT tablet (2800 bioequivalent allergen unit; Merck, Inc, Kenilworth, NJ/ALK, Hørsholm, Denmark). In period 2, subjects received a short ragweed SLIT tablet (12 Ambrosia artemisiifolia 1-U; Merck/ALK) every morning and a grass SLIT tablet every evening. In period 3, subjects received once-daily grass and ragweed SLIT tablets within 5 minutes (simultaneous intake). The primary end point was the proportion of subjects with 1 or more local swelling events in each period. Secondary end points were the proportion of subjects with 1 or more local adverse events (AEs), that discontinued the treatment because of AEs, and subjects with 1 or more local AEs requiring treatment.
  
  
  RESULTS
  No severe swellings, systemic allergic reactions, asthma attacks, or reactions requiring epinephrine were reported. Most (99%) AEs were graded mild to moderate. The proportions of subjects with 1 or more local swelling events were 14%, 22%, and 15% for periods 1, 2, and 3, respectively. For periods 1, 2, and 3, the proportions of subjects with 1 or more local AEs were 71%, 69%, and 56%, respectively; the proportions discontinuing the treatment because of treatment-related AEs were 5%, 1%, and 2%, and the proportions with 1 or more local AEs requiring treatment were 4%, 4%, and 1%.
  
  
  CONCLUSIONS
  In this trial, a 4-week sequential SLIT-tablet dosing schedule followed by simultaneous intake of timothy grass and ragweed tablets was well tolerated.
authors.affiliation: Merck & Co., Inc, Kenilworth, NJ.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Maloney
authors.affiliation: Clinical Research Institute, Inc, Minneapolis, Minn.
authors.forename: Gary
authors.initials: G
authors.lastname: Berman
authors.affiliation: Clinique Spécialisée en Allergie de la Capitale, Québec, QC, Canada.
authors.forename: Remi
authors.initials: R
authors.lastname: Gagnon
authors.affiliation: Bernstein Clinical Research Center and Division of Immunology and Allergy, University of Cincinnati, Cincinnati, Ohio.
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.affiliation: National Jewish Health, Denver, Colo.
authors.forename: Harold S
authors.initials: HS
authors.lastname: Nelson
authors.affiliation: Allergy & Asthma Center Westend, Berlin, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kleine-Tebbe
authors.affiliation: Merck & Co., Inc, Kenilworth, NJ.
authors.forename: Amarjot
authors.initials: A
authors.lastname: Kaur
authors.affiliation: Merck & Co., Inc, Kenilworth, NJ.
authors.forename: Qing
authors.initials: Q
authors.lastname: Li
authors.affiliation: Merck & Co., Inc, Kenilworth, NJ. Electronic address: hendrik.nolte@merck.com.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Nolte
mesh_terms: D000328:Adult; D000485:Allergens / Q000627:therapeutic use*; D031164:Ambrosia / Q000276:immunology; D052179:Antigens, Plant / Q000627:therapeutic use*; D002170:Canada; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D031784:Phleum / Q000276:immunology; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy*; D063729:Sublingual Immunotherapy / Q000379:methods*; D013607:Tablets; D014481:United States
chemical_list: D000485:Allergens; D052179:Antigens, Plant; D013607:Tablets
keywords: Allergic rhinitis; Dual; Grass; Immunotherapy; Immunotherapy tablet; Ragweed; Safety; Simultaneous; Sublingual