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Days with severe symptoms: an additional efficacy endpoint in immunotherapy trials
S R Durham1, A O Birk, J S Andersen
1Imperial College, National Heart and Lung Institute, London, UK.
Allergy
|July 9, 2010
Summary
Investigating days with severe symptoms in allergy immunotherapy trials revealed that the grass allergy immunotherapy tablet significantly reduced the risk of experiencing these troublesome days. This endpoint supports clinical interpretation of treatment efficacy.
Area of Science:
- Allergy and Immunology
- Clinical Trials
- Pharmacology
Background:
- Current immunotherapy trials often use average scores, necessitating endpoints for severe symptom days.
- A need exists for endpoints reflecting treatment impact on the most challenging days of the pollen season.
Purpose of the Study:
- To investigate "days with severe symptoms" as a novel efficacy endpoint in grass allergy immunotherapy.
- Evaluate the SQ-standardized grass allergy immunotherapy tablet (AIT) in a randomized controlled trial.
Main Methods:
- A multicentre, double-blind, placebo-controlled trial involving 634 subjects with grass pollen-induced rhinoconjunctivitis.
- Six definitions of severe symptom days were analyzed, with odds ratios calculated to compare treatment groups.
Main Results:
- Consistent results across definitions showed a reduced risk (odds ratios: 2.0-3.4) of severe symptom days in the grass AIT group versus placebo.
- The grass allergy immunotherapy tablet demonstrated a significant reduction in days with severe symptoms.
Conclusions:
- "Days with severe symptoms" is a valuable additional efficacy endpoint for immunotherapy trials.
- This endpoint enhances the clinical interpretation of standard efficacy measures in allergy treatment.
