title: Safety of sublingual immunotherapy Timothy grass tablet in subjects with allergic rhinitis with or without conjunctivitis and history of asthma.
abstract: BACKGROUND
  Patients with asthma may be more susceptible to adverse events (AEs) with sublingual immunotherapy tablet (SLIT-tablet) treatment, such as severe systemic reactions and asthma-related events. Using data from eight trials of grass SLIT-tablet in subjects with allergic rhinitis with/without conjunctivitis (AR/C), AE frequencies were determined in adults and children with and without reported asthma.
  
  
  METHODS
  Data from randomized, double-blind, placebo-controlled trials of Timothy grass SLIT-tablet MK-7243 (2800 BAU/75 000 SQ-T, Merck/ALK-Abelló) were pooled for post hoc analyses. Subjects with uncontrolled and severe asthma were excluded from the trials. Frequencies for treatment-emergent AEs (TEAEs), local allergic swelling (mouth or throat), systemic allergic reactions, and asthma-related treatment-related AEs (TRAEs) were calculated.
  
  
  RESULTS
  Among adults (n = 3314) and children (n = 881), 24% and 31%, respectively, had reported asthma. No serious local allergic swellings or serious systemic allergic reactions occurred in subjects with asthma treated with SLIT-tablet. There was no evidence of increased TEAEs, systemic allergic reactions, or severe local allergic swellings in adults or children with asthma treated with grass SLIT-tablet versus subjects without asthma in or outside of pollen season. There were 6/120 asthma-related TRAEs assessed as severe with grass SLIT-tablet and 2/60 with placebo, without a consistent trend among subjects with and without asthma (5 and 3 events, respectively).
  
  
  CONCLUSIONS
  In the AR/C subjects with reported well-controlled mild asthma included in these studies, grass SLIT-tablet did not increase TEAE frequency, severe local allergic swelling, or systemic allergic reactions versus subjects without asthma. There was no indication that treatment led to acute asthma worsening.
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: J
authors.initials: J
authors.lastname: Maloney
authors.forename: S
authors.initials: S
authors.lastname: Durham
authors.forename: D
authors.initials: D
authors.lastname: Skoner
authors.forename: R
authors.initials: R
authors.lastname: Dahl
authors.forename: A
authors.initials: A
authors.lastname: Bufe
authors.forename: D
authors.initials: D
authors.lastname: Bernstein
authors.forename: K
authors.initials: K
authors.lastname: Murphy
authors.forename: S
authors.initials: S
authors.lastname: Waserman
authors.forename: G
authors.initials: G
authors.lastname: Berman
authors.forename: M
authors.initials: M
authors.lastname: White
authors.forename: A
authors.initials: A
authors.lastname: Kaur
authors.forename: H
authors.initials: H
authors.lastname: Nolte
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000485:Allergens / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D001249:Asthma / Q000150:complications*; D003231:Conjunctivitis / Q000150:complications*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D031784:Phleum / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012129:Respiratory Function Tests; D065631:Rhinitis, Allergic / Q000150:complications* / Q000503:physiopathology / Q000628:therapy*; D063729:Sublingual Immunotherapy / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000485:Allergens
keywords: allergic rhinitis; asthma; grass; safety; sublingual immunotherapy