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Clinical relevance of pre- and coseasonal sublingual immunotherapy with a 300 index of reactivity 5-grass SLIT tablet in allergic rhinoconjunctivitis
Background: There is considerable interest in improving the scoring methods for evaluating the efficacy of allergen immunotherapy (AIT) and to show if this is associated with clinically meaningful results from the patient's perspective. We aimed to assess the efficacy and clinical relevance...
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| Hoofdauteurs: | , , , , |
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| Formaat: | Artikel |
| Taal: | Engels |
| Gepubliceerd in: |
Philipps-Universität Marburg
2024
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| Onderwerpen: | |
| Online toegang: | PDF Full text |
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| Samenvatting: | Background: There is considerable interest in improving the scoring methods for
evaluating the efficacy of allergen immunotherapy (AIT) and to show if this is
associated with clinically meaningful results from the patient's perspective. We
aimed to assess the efficacy and clinical relevance of a 300 index of reactivity (IR) 5‐
grass pollen sublingual immunotherapy (SLIT) tablet in children, adolescents and
adults with moderate to severe grass‐induced allergic rhinoconjunctivitis (ARC)
with or without controlled asthma using the combined symptom and medication
score CSMS0‐36.
Methods: The data of the European population that participated in 3 Phase III,
international, randomized double‐blind placebo‐controlled clinical trials were
analyzed post hoc.
Results: A total of 864 patients randomized to 300 IR 5‐grass tablet or placebo
were analyzed. Over the primary evaluation period, the difference in CSMS0‐36
between the 300 IR and placebo groups was statistically significant (point estimates:
−2.51, CI95% [−3.88; −1.14], p < 0.0001 in clinical trial1; −2.31, CI95% [−3.39;
−1.23], p < 0.0001 in CT2; and −2.31, CI95% [−3.58; −1.03], p = 0.0004 in CT3). The
relative differences between the 300 IR 5‐grass tablet and placebo were −29.7%,
−33.8%, and −26.3%, respectively. The results based on CSMS0‐36 were consistent
with those obtained with the primary endpoints of the trials and support the
consideration of the 2‐point threshold of the CSMS0‐36 for clinical relevance of AIT.
Conclusion: Post hoc analysis of 3 CTs with the 300 IR 5‐grass SLIT tablet
confirmed its significant and clinically relevant effect in the European population
with grass pollen‐induced ARC with or without controlled asthma. |
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| Beschrijving item: | Gefördert durch den Open-Access-Publikationsfonds der UB Marburg. |
| DOI: | 10.1002/clt2.12321. |