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The primary efficacy endpoint is the proportion of patients treated with AR201 compared with placebo who tolerate a single highest dose of at least 1,000 mg dried egg white protein with no more than mild allergy symptoms at the exit DBPCFC. Secondary efficacy endpoints include the proportion of patients who tolerate a single highest dose of at least 300 mg dried egg white protein with no more than mild allergy symptoms during the exit DBPCFC; the proportion of patients who tolerate a single highest dose of at least 600 mg dried egg white protein with no more than mild allergy symptoms during the exit DBPCFC and the maximum severity of allergy symptoms after consuming dried egg white protein during the exit DBPCFC.
The researchers found that 65 patients developed allergic reactions (responders) to DBPCFC with birch pollen-related foods (103 DBPCFC).
At the end of the period, patients were administered a DBPCFC with a higher maximum challenge dose of 1,000 mg (2,043 mg cumulative) of peanut protein.
In the present study, infants from the PIFA study who were diagnosed as having a food allergy according to DBPCFC and two age-matched controls with birthdates closest to the index were included for analysis.
Single-blind placebo-controlled food challenges (SBPCFCs) and open food challenges are more readily available, but unlike DBPCFCs they do not eliminate clinician and patient bias.
The definitive test for CMPI is the double-blind placebo controlled food challenge (DBPCFC) that must be done in a provider's office or hospital over several hours (Heine et al., 2002).
There will be additional DBPCFCs after a 24-week maintenance period (for which the AR101-dupilumab patients will be re-randomised 1: 1 to AR101-dupilumab or AR101-placebo) and at the end of a 12-week, treatment-free follow-up period.
Using DBPCFC, Sampson (2001) conducted a prospective study of children and adolescents and established 95% predictive decision points for egg-, milk-, peanut-, and fish-specific IgE antibody, as measured in the Pharmacia CAP System.
The DBPCFC is an excellent method for confirming suspected allergy.
After approximately one year of treatment, patients completed an exit DBPCFC. In the trial's primary analysis of ages 4-17, patients were highly atopic and highly sensitive to peanut.
The positive and negative predictive values of a limited number of food-specific IgE determinations have been published that define cutoff values that reliably predict the likelihood of food allergy when compared with double-blind, placebo-controlled, food challenges (DBPCFC) (Sampson 2001).
In the primary analysis of 496 patients ages 4-17, 67.2% of AR101 patients tolerated a single highest dose of at least 600 mg of peanut proteinwith no more than mild symptoms in the exit DBPCFC, compared to 4.0% of placebo patients.
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