Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study

Publication date: Available online 12 September 2019Source: The LancetAuthor(s): R Sharon Chinthrajah, Natasha Purington, Sandra Andorf, Andrew Long, Katherine L O'Laughlin, Shu Chen Lyu, Monali Manohar, Scott D Boyd, Robert Tibshirani, Holden Maecker, Marshall Plaut, Kaori Mukai, Mindy Tsai, Manisha Desai, Stephen J Galli, Kari C NadeauSummaryBackgroundDietary avoidance is recommended for peanut allergies. We evaluated the sustained effects of peanut allergy oral immunotherapy (OIT) in a randomised long-term study in adults and children.MethodsIn this randomised, double-blind, placebo-controlled, phase 2 study, we enrolled participants at the Sean N Parker Center for Allergy and Asthma Research at Stanford University (Stanford, CA, USA) with peanut allergy aged 7–55 years with a positive result from a double-blind, placebo-controlled, food challenge (DBPCFC; ≤500 mg of peanut protein), a positive skin-prick test (SPT) result (≥5 mm wheal diameter above the negative control), and peanut-specific immunoglobulin (Ig)E concentration of more than 4 kU/L. Participants were randomly assigned (2·4:1·4:1) in a two-by-two block design via a computerised system to be built up and maintained on 4000 mg peanut protein through to week 104 then discontinued on peanut (peanut-0 group), to be built up and maintained on 4000 mg peanut protein through to week 104 then to ingest 300 mg peanut protein daily (peanut-300 group) for 52 weeks, or to receive oat flour (placebo group). DBPCFCs...
Source: The Lancet - Category: General Medicine Source Type: research