Safety and tolerability of 5-grass pollen tablet sublingual immunotherapy: pooled analysis and clinical review

Expert Opin Drug Saf. 2015 May;14(5):777-88. doi: 10.1517/14740338.2015.1017468. Epub 2015 Mar 3.


Introduction: The 5-grass pollen tablet (Oralair®, Stallergenes, Antony, France) is a once-daily preseasonal and coseasonal sublingual immunotherapy (SLIT) that is effective in controlling the symptoms of allergic rhinoconjunctivitis and in reducing the need for symptomatic medication.

Areas covered: The body of safety data gathered from the 5-grass pollen tablet clinical development program, post-approval studies, and more than 6 years of real-life experience demonstrates the safety and tolerability profile of the 5-grass pollen tablet across all age groups. Adverse events (AEs) are generally mild or moderate in severity, and rarely lead to treatment discontinuation. AEs also tend to decline in frequency and severity over time and with repeated treatment. The most frequent treatment-emergent AEs are local-site oropharyngeal reactions (e.g., oral pruritus, throat irritation, tongue pruritus, mouth edema, ear pruritus), which are consistent with the sublingual route of administration.

Expert opinion: The first dose of the 5-grass pollen tablet should be administered under the supervision of an experienced physician, to allow for optimal monitoring and timely management of AEs, should they occur. The 5-grass pollen tablet can be administered at home after the first dose, and patients and carers should be educated on how to manage adverse reactions, unplanned treatment interruptions and situations in which SLIT should be withheld.

Keywords: 5-grass pollen tablet; allergic rhinitis; allergic rhinoconjunctivitis; asthma; clinical trial; pollinosis; safety; sensitization; sublingual immunotherapy; tolerability.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Child
  • Child, Preschool
  • Conjunctivitis, Allergic / immunology
  • Conjunctivitis, Allergic / therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Poaceae / immunology
  • Pollen / immunology
  • Rhinitis, Allergic / immunology
  • Rhinitis, Allergic / therapy*
  • Sublingual Immunotherapy / adverse effects
  • Sublingual Immunotherapy / methods*
  • Time Factors
  • Young Adult