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Published on: March 8, 2012
Assessment of specific immunotherapy efficacy using a novel placebo score-based method
Anthony J Frew1, Lawrence DuBuske, Paul K Keith
1Department of Respiratory Medicine, Royal Sussex County Hospital, Brighton, UK. anthony.frew@bsuh.nhs.uk
Summary
Symptom scores in placebo patients better reflect local allergen burden than pollen counts in immunotherapy trials. This method improves the assessment of allergen immunotherapy effectiveness, especially in multicenter studies.
Area of Science:
- Allergy and Immunology
- Clinical Trials
- Environmental Health
Background:
- Pollen counts may inaccurately represent allergen exposure in multicenter trials.
- Remote pollen monitoring can lead to misrepresentation of local allergen burden.
Purpose of the Study:
- To evaluate if patient symptomatology in placebo groups is a superior indicator of local allergen burden.
- To compare the efficacy of allergen immunotherapy using symptom scores versus pollen counts.
Main Methods:
- Reanalyzed data from a multicenter, placebo-controlled grass pollen immunotherapy trial.
- Identified peak symptom/medication score weeks (PlSW) in placebo patients at each center.
- Compared immunotherapy benefits during PlSW versus peak pollen count weeks (PoCW).
Main Results:
- Allergen immunotherapy showed a greater benefit over placebo during PlSW (18.5%) compared to PoCW (13.6%).
- The PlSW analysis yielded higher statistical significance (P = .0001) than PoCW analysis (P = .0038).
- Improved discrimination was consistent across patient subgroups and geographical locations.
Conclusions:
- A novel analysis using peak placebo symptom weeks (PlSW) enhances the discrimination of immunotherapy effects.
- This PlSW method offers improved assessment of allergen immunotherapy efficacy compared to traditional pollen counts.
- The PlSW analysis is potentially applicable to both prospective and retrospective studies.
