PURPOSE OF THE STUDY.
To determine that oral immunotherapy (OIT) to egg is safe and effective to desensitize patients and induce sustained unresponsiveness.
A double-blind, randomized placebo-controlled study of 55 children, 5 to 11 years of age, sensitive to egg, with 40 receiving OIT and 15 placebo.
Initial dose escalation and buildup, maintenance phases up to 2 g of egg protein (one-third egg). This was followed by an oral food challenge with egg white powder at 10 months and 22 months. Children who successfully passed the challenge at 22 months discontinued OIT and avoided egg consumption for 4 to 6 weeks. At 24 months, these children had oral food challenge with egg powder and a cooked egg to test for unresponsiveness.
After 10 months of therapy, none of the children who received placebo and 55% of those who received OIT passed an oral food challenge of up to 5 g of egg protein and were considered desensitized. At 22 months, 75% of children in the OIT group were desensitized and tolerated up to 10 g of egg protein. In the OIT group, 28% passed the oral food challenge at 24 months and were considered to have sustained unresponsiveness. At 30 to 36 months, all children who had passed the oral food challenge at 24 months were consuming egg without restrictions.
This study shows that OIT can desensitize a high proportion of children with egg allergy and induce sustained unresponsiveness.
This landmark study shows that desensitization, an increased threshold while on daily treatment, to egg protein can be achieved in most patients with a 1% rate of more than mild reactions during OIT. Having 28% achieve sustained unresponsiveness off daily treatment is encouraging, but more studies are needed to determine if this observation reflects a treatment “cure” or natural course of the allergy. Overall, this study provides a step forward to help patients with significant egg sensitivity to not only ensure safety but also allow ingestion of egg protein.
- Copyright © 2013 by the American Academy of Pediatrics