Consistent efficacy and safety of sublingual immunotherapy tablets across allergens and geographic regions

• DOI: 10.2500/aap.2024.45.240020
• Publication Date: 2024-05-18T01:05:57Z
• Authors: Thomas Stranzl; David I. Bernstein; Tomokazu Matsuoka; Stephen Durham; Yuriko Maekawa; Peter Sejer Andersen; Josephine Nolte; Veronica Hulstrom; Hendrik Nolte
• Keywords: Sublingual Immunotherapy; Clinical endpoint

Background: The clinical development program of the SQ grass, ragweed, tree, and house dust mite (HDM) sublingual immunotherapy (SLIT)-tablets for allergic rhinitis/conjunctivitis (AR/C) included trials conducted in North America, Europe, Japan. Objective: Data from these were analyzed to assess efficacy, immunologic mechanisms, safety outcomes across allergens geographic regions. Methods: Thirteen phase III, double-blind, placebo controlled subjects with AR/C Europe (including Russia), Japan (N = 7763 analyzed). Trials generally similar respect medical practice, target population, eligibility criteria, efficacy monitoring. approved doses America Europe. Four statistical models used enhance comparison end points among trials. Results: SLIT-tablets demonstrated consistent regions, regardless analysis used. Relative improvement primary point compared by using predefined protocol ranged 17.9% 32.8%, 17.5% 19.3%, 20.6% 38.3%, 39.6% HDM, tree SLIT-tablets, respectively. kinetics specific immunoglobulin E (IgE) IgG4 responses Local application-site reactions most common adverse events all Most treatment-related regions mild severity. rate systemic was (0%‐0.54%). Conclusion: Confirmatory III treatment showed immunologic,