QuoteInterpretation
To our knowledge, we did the first phase 2 study appropriately powered to derive an accurate estimate of the effect size of the treatment in children aged 7–15 years. By contrast with other studies, we assessed a representative UK population including children with severe reactions, with allergy confirmed by DBPCFC. 84% and 91% of participants could tolerate the equivalent of five peanuts per day, and a high rate of desensitisation (ability to tolerate the equivalent of roughly ten peanuts) was shown. There was a substantial effect size, and improvement in quality of life with a good safety profile. Tolerance after cessation of OIT was not assessed. Our data apply to the population studied and the doses employed, and there is a need for replication and expansion of populations studied. This study shows that peanut immunotherapy is an effective and well tolerated treatment in this age group.
QuoteThe primary outcome, desensitisation, was recorded for 62% (24 of 39 participants; 95% CI 45–78) in the active group and none of the control group after the first phase (0 of 46; 95% CI 0–9; p<0·001). 84% (95% CI 70–93) of the active group tolerated daily ingestion of 800 mg protein (equivalent to roughly five peanuts). Median increase in peanut threshold after OIT was 1345 mg (range 45–1400; p<0·001) or 25·5 times (range 1·82–280; p<0·001). After the second phase, 54% (95% CI 35–72) tolerated 1400 mg challenge (equivalent to roughly ten peanuts) and 91% (79–98) tolerated daily ingestion of 800 mg protein.