After eight weeks, the children underwent rapid oral desensitization with up to five food allergens in a hospital, while continuing with omalizumab for another eight weeks. This began with giving the children food allergen protein in the form of a flour, they were give a 5mg of total protein - divided equally for each allergen. This was increased to 1250mg over a 2.5 hour period, while vital signs were constantly monitored. Antihistamines, steroids and injectable epinephrine were available at all times. The children were observed for two hours after the maximum allergen dose was given.The participants continued with home dosing of allergens by ingesting their maximum tolerated dose after each meal. After two weeks, they returned to the hospital where the doses were escalated if the daily food protein doses were well tolerated. During the trial, no serious adverse events were reported, and of the allergic reactions recorded 94% were mild (i.e. itching). Most home reactions occurred during the first months of therapy, and reactions dropped by 70% after 6 months. All participants reached a 10-fold equivalent dose of each of their allergens after 2 months of OIT.
The researchers noted the limitations of this study. This is a small single site, open label, Phase 1 study, so further larger, multi site Phase 2 studies need to be conducted. The authors caution that multi-food OIT is experimental and should only be conducted in a hospital setting with trained personnel and should be conducted as per national regulatory and local regulatory guidelines.Senior author Kari Nadeau says: "In this Phase 1 safety study, we have shown that the study participants allergic to multiple foods were safely and rapidly desensitized to up to five food allergens simultaneously, using an OIT protocol with concomitant treatment with omalizumab. This is the first published study on using multiple-OIT and omalizumab in combination. These findings are particularly relevant considering the already high, and likely growing, number of food-allergic participants who are sensitized to more than one food allergen." Bron: www.medicalnewstoday.com