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The problem
Intervention: Epicutaneous immunotherapy (EPIT) using daily 250 μg DBV712 peanut protein patch applied to skin
Who it was tested with: Children aged 4 to 11 years with peanut allergy who completed the 12-month PEPITES randomized trial and enrolled in the 3-year PEOPLE open-label extension (141 had assessable food challenge data at month 36).
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge." The double-blind food challenge at month 36 provides objective measurement of desensitization against the prior randomized trial baseline, demonstrating continued clinical benefit from extended EPIT treatment.
The study was open-label after the initial randomized phase, limiting ability to distinguish treatment effects from natural history or placebo effects. Loss to follow-up occurred (141 of 198 subjects had assessable challenge data). The sustained unresponsiveness assessment included only 18 volunteers, making that finding less robust.
Across countries and designs
3 studies · 9 countries
