Specific oral tolerance induction with raw hen’s egg in children with very severe egg allergy: A randomized controlled trial

Iacono, Iride Dello; Tripodi, Salvatore; Calvani, Mauro; Panetta, Valentina; Verga, Maria Carmela; Sopo, Stefano Miceli

doi:10.1111/j.1399-3038.2012.01349.x

Cited by 76 publications

(69 citation statements)

References 30 publications

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“…Despite the fact that control patients were younger and therefore they had more likely to develop natural tolerance. Our results are similar to those obtained by other researchers reporting 70%‐90% success with total desensitization, equivalent to one whole raw egg or one raw egg white …”

Section: Discussionsupporting

confidence: 92%

Egg oral immunotherapy in children (SEICAP I): Daily or weekly desensitization pattern

Martín-Muñoz

Belver

Lebrero

et al. 2018

Pediatric Allergy Immunology

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Section: Discussionsupporting

confidence: 92%

Egg oral immunotherapy in children (SEICAP I): Daily or weekly desensitization pattern

Martín-Muñoz

Belver

Lebrero

et al. 2018

Pediatric Allergy Immunology

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“…Several prior studies have shown some success in using these approaches for single specific food allergens such as milk [8-15], egg [13,14,16-18], peanut [19-24], and hazelnut [25]. These current types of experimental treatments need to be tested for optimization in safety, efficacy, and length of time [26-34].…”

Section: Introductionmentioning

confidence: 99%

Phase 1 results of safety and tolerability in a rush oral immunotherapy protocol to multiple foods using Omalizumab

Bégin

Dominguez

Wilson

et al. 2014

All Asth Clin Immun

200

167

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BackgroundUp to 30% of patients with food allergies have clinical reactivity to more than one food allergen. Although there is currently no cure, oral immunotherapy (OIT) is under investigation. Pilot data have shown that omalizumab may hasten the ability to tolerate over 4 g of food allergen protein.ObjectiveTo evaluate the safety and dose tolerability of a Phase 1 Single Site OIT protocol using omalizumab to allow for a faster and safe desensitization to multiple foods simultaneously.MethodsParticipants with multiple food allergies received OIT for up to 5 allergens simultaneously with omalizumab (rush mOIT). Omalizumab was administered for 8 weeks prior to and 8 weeks following the initiation of a rush mOIT schedule. Home reactions were recorded with diaries.ResultsTwenty-five (25) participants were enrolled in the protocol (median age 7 years). For each included food, participants had failed an initial double-blind placebo-controlled food challenge at a protein dose of 100 mg or less. After pre-treatment with omalizumab, 19 participants tolerated all 6 steps of the initial escalation day (up to 1250 mg of combined food proteins), requiring minimal or no rescue therapy. The remaining 6 were started on their highest tolerated dose as their initial daily home doses. Participants reported 401 reactions per 7,530 home doses (5.3%) with a median of 3.2 reactions per 100 doses. Ninety-four percent (94%) of reactions were mild. There was one severe reaction. Participants reached their maintenance dose of 4,000 mg protein per allergen at a median of 18 weeks.ConclusionThese phase 1 data demonstrate that rush OIT to multiple foods with 16 weeks of treatment with omalizumab could allow for a fast desensitization in subjects with multiple food allergies. Phase 2 randomized controlled trials are needed to better define safety and efficacy parameters of multi OIT experimental treatments with and without omalizumab.

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“…Recently, new trials using protocols that omit a rush escalation phase known as home-based OIT, have been used due to the improved safety associated with these methods. Our regimen also omits the rush escalation phase, and is unique in that we used an intermittent loading dose (i.e., 2 to 3 times a week) instead of daily loading as in previous home-based OITs [14,18-20]. In order to ensure safety, we also kept a fixed dose throughout the maintenance period at home, and avoided any escalations, as indicated in previous protocols [14,18-20].…”

Section: Discussionmentioning

confidence: 99%

“…Our regimen also omits the rush escalation phase, and is unique in that we used an intermittent loading dose (i.e., 2 to 3 times a week) instead of daily loading as in previous home-based OITs [14,18-20]. In order to ensure safety, we also kept a fixed dose throughout the maintenance period at home, and avoided any escalations, as indicated in previous protocols [14,18-20]. The advantage of intermittent loading is the safety demonstrated by the number of adverse events related to doses administered at home; 45/10380 (0.43%) for home-based OIT throughout the current study period, which is considerably better than that of the previous studies ranging from 0.99% to 24.2% [14,18,20,28].…”

Section: Discussionmentioning

confidence: 99%

“…In order to ensure safety, we also kept a fixed dose throughout the maintenance period at home, and avoided any escalations, as indicated in previous protocols [14,18-20]. The advantage of intermittent loading is the safety demonstrated by the number of adverse events related to doses administered at home; 45/10380 (0.43%) for home-based OIT throughout the current study period, which is considerably better than that of the previous studies ranging from 0.99% to 24.2% [14,18,20,28]. This is due to an opportunity to omit the loadings on weekends, or sick days; the former lower the risk of developing allergic reaction out of office hours of the clinic and the latter is associated with the increased risk of allergic reaction.…”

Section: Discussionmentioning

confidence: 99%

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Home-based oral immunotherapy (OIT) with an intermittent loading protocol in children unlikely to outgrow egg allergy

Sudo

Taniuchi

Takahashi

et al. 2014

All Asth Clin Immun

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BackgroundHome based oral immunotherapy (OIT) for food allergy has often been used for young children in Japan, the majority of whom are believed to outgrow the allergy by the school age, therefore the true efficacy of the therapy has been controversial. The aim of this study was to evaluate the efficacy and safety of a newly developed slow- type home-based oral immunotherapy (OIT) regimen in children with hen’s egg (HE) allergy, who had low likelihood of outgrowing the allergy, with treatment involving only elimination diet.MethodWe retrospectively reviewed the medical records of 43 children with egg allergy (30 males; median age 6) who fulfilled Burks et al.’s criteria of being unlikely to outgrow the allergy. Thirty children who agreed to start OIT were assigned to the treatment group, and 13 who did not want to participate immediately were assigned to the untreated group; the patients underwent an elimination diet for 1 year, during which they were monitored. The OIT regimen involved the intake of the maximum tolerated dose 2 to 3 times a week at home, with initial dose introduction followed by dose build-ups with medical supervision. We statistically evaluated the rate of children who changed their threshold up to 32 g of egg – defined as, oral tolerance induction– in both the groups for 1 year and in the OIT group for 2 years, as well as the rate of children who fulfilled Savage et al.’s criteria of clinical tolerance after reaching the abovementioned remission stage.ResultsThe rate of children who achieved oral tolerance induction to 32 g of egg after 1 year in the OIT group (9/30) was significantly higher than that in the untreated group (0/13). The total rate within the OIT group was significantly increased from 9/30 at 1 year to 17/30 at two years without any severe adverse reaction; of the above 17 children, we followed 14 children, and noted that 11 of these were able to obtain clinical tolerance.ConclusionThe home-based OIT with an intermittent loading protocol was very safe and effective in children with a low likelihood of outgrowing egg allergy.

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Specific oral tolerance induction with raw hen’s egg in children with very severe egg allergy: A randomized controlled trial

Abstract: Six months of SOTI with raw HE emulsion resulted in partial tolerance, with regular intake, in a significant percentage of children with severe egg allergy.

Cited by 76 publications

References 30 publications

Egg oral immunotherapy in children (SEICAP I): Daily or weekly desensitization pattern

Egg oral immunotherapy in children (SEICAP I): Daily or weekly desensitization pattern

Phase 1 results of safety and tolerability in a rush oral immunotherapy protocol to multiple foods using Omalizumab

Home-based oral immunotherapy (OIT) with an intermittent loading protocol in children unlikely to outgrow egg allergy

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