Data Library
A practical guide to prescribing sublingual immunotherapy tablets in North America for pediatric allergic rhinoconjunctivitis: an injection-free allergy immunotherapy option
Allergic rhinoconjunctivitis (ARC) is a common disease that affects individuals of all ages. Pediatricians may be the first (and only) point of care for children with ARC. Sublingual immunotherapy (SLIT)-tablets are a convenient at-home, injection-free allergy immunotherapy option that can be used for the treatment of ARC. This paper provides a practical guide for pediatricians to aid in prescribing SLITtablets to children with ARC in North America. Topics include a summary of the available SLIT-tablets and their efficacy and safety, guidance on when SLITtablets are an appropriate option, and how to diagnose ARC and identify culprit allergens. Practical guidance is also provided through a proposed decision tree, a prescribing checklist and prescribing procedures, and suggested follow-up assessments.
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Summer 2023
Safety of house dust mite sublingual immunotherapy tablet in adolescents with allergic rhinoconjunctivitis: Clinical trial results
This clinical trial was a Phase 3, open-label, single-arm, 28-day safety trial of daily HDM SLIT-t (12 SQ-HDM dose) in European adolescents 12-17 years of age. This data was then compared with existing adolescent subpopulation data from previously described Phase 3 trials in North America (P001) or Japan (TO-203-3-2). The primary endpoint was at least one treatment-emergent adverse event (TEAE).The percentage of the MT-18 cohort (n=253), P001 (n=189), and TO-203-3-2 (n=206) treated with the 12 SQ-HDM reporting any TEAE was 88%, 95%, and 93%, respectively. The percentage reporting any treatment-related adverse event (TRAE) was 86%, 93%, and 66%, respectively. TRAEs were most commonly local application site reactions, mild in intensity and were typically experienced within the first 1-2 days of treatment. The authors concluded that the HDM SLIT-t was safe and well-tolerated in European, North American, and Japanese adolescents.
Read moreSummer 2023
Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial
Here, the efficacy and safety of ragweed SLIT tablets during peak and throughout the pollen season was evaluated in children and adolescents in a double-blind, placebo-controlled clinical trial (N=1025; 77.8% polysensitized). The mean total combined score (TCS; sum of Daily Rhinoconjunctivitis Symptom Score [DSS] and Daily Medication Score [DMS]) was assessed for the peak (primary endpoint) and the entire ragweed pollen season (key secondary endpoint). DSS and DMS during peak season were other key secondary endpoints. The relative improvement in TCS with ragweed SLIT tablets compared to placebo during the peak season (≈186 grains/m3/day) was -38.3% and during the entire season (≈85 grains/m3/day) was -32.4%. There were no reported events of anaphylaxis, airway compromise, or serious systemic allergic reactions related to treatment. The authors concluded that ragweed SLIT tablets were effective in children with RA/C during peak season, when symptoms were greatest, and throughout the season. To learn more about this study, watch Dr. Anne Ellis’ Investigator Insights video here.
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