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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Spring 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 moreSpring 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 the peak and entire pollen season were evaluated in children and adolescents in a double-blind placebo-controlled clinical trial (N=1025; 77.8% polysensitized). The average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) was assessed for peak (primary endpoint) and the entire ragweed pollen season (key secondary endpoint). DSS and DMS during peak season were additional key secondary endpoints. The relative TCS improvement with ragweed SLIT-tablets versus placebo during peak season (≈186 grains/m3/day) was −38.3% and during the entire season (≈85 grains/m3/day) was −32.4%. No events of anaphylaxis, airway compromise or severe treatment-related systemic allergic reactions were reported. The authors concluded that ragweed SLIT-tablets were efficacious in children with AR/C during peak season when symptoms were greatest and throughout the entire season. To learn more about this study, watch Dr. Anne Ellis’ Investigator Insights video here.
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