Researchers have reported promising results from the first multicentre, rigorous clinical trial of wheat oral immunotherapy (OIT).
The findings, published in the Journal of Allergy and Clinical Immunology, suggest 52 weeks of treatment with the immunotherapy was associated with desensitisation in 52 per cent of wheat-allergic individuals.
The study randomised 46 patients aged between 4.2 and 22.3 years to low-dose vital wheat gluten (VWG) OIT or placebo.
At year 1 double-blind, placebo-controlled food challenge (DBPCFC), active subjects continued OIT for another year and underwent a year 2 DBPCFC and, if passed, a subsequent off-therapy DBPCFC. Placebo-treated subjects crossed over to high-dose immunotherapy.
At year 1, 12 (52.2%) of 23 participants treated with low-dose immunotherapy achieved the primary endpoint of a successfully consumed dose (SCD) of 4,443 mg of wheat protein (WP) or more, compared to 0 (0%) of 23 placebo-treated subjects (P<.0001>
At year 2, seven (30.4%) immunotherapy-treated patients were desensitised to an SCD of 7,443 mg of WP. Three (13%) achieved sustained unresponsiveness 8-10 weeks off therapy.
Among placebo-treated subjects who crossed over to high-dose immunotherapy, 12 (57.1%) of 21 were desensitised after one year.
In year 1, 15.4 per cent of immunotherapy doses were associated with adverse reactions.