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

Abstract

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

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Erratum

Declaration of interest

B Bons is an employee of Stallergenes. In the past 5 years, A Didier has received honoraria from Stallergenes for participating in expert advisory board meetings and for coordinating clinical studies on the 5-grass pollen tablet. Funding for this paper was received from Stallergenes, who funded medical writing assistance from James Reed of Newmed Publishing Services. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents, received or pending, or royalties.

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