12 SQ-Bet SLIT for treating moderate to severe allergic rhinitis or conjunctivitis caused by tree pollen in people 5 years and over

Tree pollen allergy

• mean prevalence of sensitization to birch pollen has been estimated to range from approximately 8% to 16% in general European populations, from 9.4% to 22% across different regions of Canada and from 11% to 20% across US regions (1)
  • pollen from birch and other members of the birch homologous group including alder, hornbeam, hazel, beech and oak is a major reason for allergic rhinitis and possibly also asthma symptoms
    • members of the birch homologous group are all characterized by containing allergen homologous to the major birch allergen Bet v 1

It is stated that allergen immunotherapy (AIT) is the only available treatment modality with the potential to modify the natural course of the allergic disease by induction of tolerance (1,2):

• standardized quality (SQ) tree sublingual immunotherapy (SLIT)-tablet is an option for the treatment of tree pollen allergy induced by birch and other species in the birch homologous group
• the SQ tree SLIT-tablet is an oral lyophilisate for at-home use containing a standardized allergen extract from white birch pollen (Betula verrucosa) (2)
  • birch pollen is recommended as the representative allergen source for allergy immunotherapy targeting allergies caused by pollen from the birch-homologous group, primarily because of its high degree of inhibition of human IgE binding to alder, hazel, and oak allergen extracts

Tolerability and safety of the SQ tree SLIT-tablet was investigated using pooled safety data from two phase-II and one phase-III trials in adults and adolescents with allergic rhinitis and/or conjunctivitis (1)

• most frequent treatment-related adverse events with the tree SLIT-tablet were oral pruritus and throat irritation
• no differences were seen in the risk of moderate to severe adverse events across subgroups

NICE state with respect to the use of 12 SQ-Bet SLIT for treating moderate to severe allergic rhinitis or conjunctivitis caused by tree pollen in people 5 years and over (3):

• 12 standardised quality betula verrucosa pollen sublingual lyophilisate (12 SQ-Bet SLIT) can be used, within its marketing authorisation, as an option to treat moderate to severe allergic rhinitis or conjunctivitis caused by pollen from the birch homologous group of trees in people aged 5 years and over with:
  • symptoms despite using symptom-relieving medicines
  • a positive sensitisation test (skin prick test or specific immunoglobulin E) to a member of the birch homologous group

The NICE committee note (3):

“..Clinical-trial evidence shows that 12 SQ-Bet SLIT, a sublingual immunotherapy, reduces the severity of allergic rhinitis and conjunctivitis symptoms compared with placebo (both with symptom-relieving medicines). There is no direct evidence comparing 12 SQ-Bet SLIT with subcutaneous immunotherapy, but clinical expert opinion is that they may have similar effectiveness..”

Reference:

1. Biedermann T, Couroux P, Greve TM, Mäkelä M. Safety of the standardized quality tree sublingual immunotherapy tablet: Pooled safety analysis of clinical trials. Allergy. 2021 Dec;76(12):3733-3742.
2. Biedermann T et al. The SQ tree SLIT-tablet is highly effective and well tolerated: Results from a randomized, double-blind, placebo-controlled phase III trial. J Allergy Clin Immunol. 2019 Mar;143(3):1058-1066.e6.
3. NICE (August 2026). 12 SQ-Bet SLIT for treating moderate to severe allergic rhinitis or conjunctivitis caused by tree pollen in people 5 years and over.