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Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy
M Worm1, T Higenbottam2, O Pfaar3,4
1Department Campus Charité Mitte, Universitätsmedizin Berlin, Berlin, Germany.
Allergy
|May 21, 2018
Summary
Increasing the cumulative dose of Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A (POLLINEX® Quattro Plus) significantly improved immunotherapy efficacy by 50% without compromising safety. This study determined the optimal dose for short-course subcutaneous immunotherapy against birch pollen allergy.
Area of Science:
- Allergy and Immunology
- Pharmacology
- Clinical Trials
Background:
- POLLINEX® Quattro Plus (Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A) is an effective, well-tolerated short-course subcutaneous immunotherapy for birch pollen allergy.
- Two Phase II studies were conducted to establish the optimal cumulative dose for this immunotherapy.
Purpose of the Study:
- To determine the optimal cumulative dose of POLLINEX® Quattro Plus for birch pollen immunotherapy.
- To evaluate the dose-response relationship and efficacy of varying cumulative doses.
Main Methods:
- The studies involved administering 6 weekly subcutaneous injections of POLLINEX® Quattro Plus outside the pollen season.
- Conjunctival Provocation Tests were used to measure the reduction in Total Symptom Scores, with analysis of dose response and median effective dose (ED50).
Main Results:
- Statistically significant dose responses were observed, with the highest cumulative dose approaching a plateau.
- The median effective dose (ED50) indicated a potency of POLLINEX® Quattro Plus at 2723 SU, which is less than half the current dose.
- Treatment-emergent adverse events were mild, short-lived, and similar across active dose groups, with over 85% compliance.
Conclusions:
- Increasing the cumulative dose of POLLINEX® Quattro Plus by 5.5-fold (from 5100 to 27 300 SU) significantly enhanced efficacy by 50% compared to placebo, without compromising safety.
- A curvilinear dose response shape was confirmed for this immunotherapy.
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