JAMA editorial says DBV trial results ‘not easy to interpret’

In an editorial published in JAMA, Jody Zylke, MD, says the peanut allergy results from DBV Technologies are “not easy to interpret.” After one year, 35.3% of children who received the peanut patch were responders versus 13.6% of the placebo group, a statistically significant difference by traditional statistical measures, Zylke writes. “However, the definition of a clinically significant response, recommended by the Food and Drug Administration and agreed to by the sponsor, was that the lower bound of the 95% CI around the difference should meet or exceed 15%. The lower bound of the 95% CI was 12.4%, meaning the main result did not reach the criterion for a positive trial result,” she added. Shares of DBV Technologies are down 25c to $7.72 in midday trading.

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