A Streamlined Strategy for Basophil Activation Testing in a Multicenter Phase III Clinical Trial

Area of Science:

• Immunology
• Allergy Research
• Clinical Trials

Background:

• The basophil activation test (BAT) has faced limitations in clinical research due to technical challenges.
• Novel streamlined approaches, such as the streamlined basophil activation test (sBAT) with ready-to-use reagents, offer improved flexibility for clinical implementation.

Purpose of the Study:

• To assess the feasibility of implementing sBAT in a multicenter clinical trial setting.
• To evaluate sBAT's utility in predicting outcomes of peanut oral food challenges within the EPITOPE trial.

Main Methods:

• Whole blood samples from 241 children (1-3 years) in the EPITOPE study were analyzed using sBAT.
• A machine learning approach integrated sBAT data, clinical characteristics, and peanut-specific IgE to predict challenge outcomes.
• Prediction models were developed using randomly split training and validation datasets.

Main Results:

• Basophil activation markers (CD203c, CD63) correlated with eliciting dose (ED) and severity of peanut reactions.
• sBAT demonstrated high sensitivity (0.85-0.86) in predicting ED and epinephrine use, with moderate specificity (0.60-0.80).
• While not improving prediction of severe reactions alone, sBAT combined with other data enhanced prediction of higher EDs (>300 mg).

Conclusions:

• Streamlined basophil activation test (sBAT) facilitates multicenter trial implementation.
• sBAT retains the potential of traditional BAT for characterizing allergic patients.
• sBAT shows promise in predicting outcomes of oral food challenges in peanut allergy.