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Adverse effects during specific oral tolerance induction: in home phase

Barbi, E.; Longo, G.; Berti, I.; Matarazzo, L.; Rubert, L.; Saccari, A.; Lenisa, I.; Ronfani, L.; Radillo, O.; Ventura, A.

Published in Allergol Immunopathol (Madr). 2012;40:41-50. - vol.40 núm 01

English: [ Abstract | Full text | PDF ]

Abstract

Background

Specific oral tolerance induction (SOTI) is a promising approach for severe food allergies. There are little data in the literature regarding the home-phase of SOTI, not only with regard to type and frequency of adverse reactions but also regarding the most suitable treatment and protocol.

Aims

To define the incidence and severity of adverse reactions, possible risk factors, and the safety and effectiveness of the home-phase of an original SOTI protocol in a large group of children with severe cow's milk (CM) allergy, after the hospital “rush” phase.

Methods

The study was conducted by recording in-home phase adverse events, success and failure as reported by parents, and calling families. Adverse reactions were treated following the International Guidelines, arbitrarily modified by introducing nebulised epinephrine for respiratory reactions, oral beclomethasone for acute gastric pain and oral cromolyn for recurrent gastric pain.

Results

Out of 140 patients, 132 were contacted; eight were inaccessible (follow-up 2–84 months). The number of adverse reactions was 1 in every 100 doses. The reactions were treated with nebulised epinephrine (221 reactions), IM epinephrine (6 reactions), and other drugs. Patients with high specific IgE levels (greater than 100kU_A/L) and lower CM dose (less than 5ml) at the end of in-hospital phase showed a higher risk both for number of reactions and use of nebulised epinephrine.

Conclusions

The home phase of SOTI was characterised by a significant number of adverse reactions, mostly managed with an acceptable rate of side effects. Nebulised epinephrine played a pivotal role in respiratory reactions.

Key words: Food allergy. Specific oral tolerance induction (SOTI). Adverse reactions. Nebulised epinephrine. Inhaled epinephrine.

Introduction

Introduction Food allergy is the primary cause of anaphylaxis in children and cow milk's (CM) proteins are the main offender in Europe.¹ Specific oral tolerance induction (SOTI) is a promising approach in the treatment of severe CM allergy. Recent reports have demonstrated the efficacy of different oral desensitisation protocols during the hospital phase with limited side effects.²^,³^,⁴^,⁵^,⁶ Nevertheless, the number of children who have undergone the treatment is still small and, as a result of this, SOTI is considered an experimental approach which is to be limited to highly defined settings. Furthermore, as the success of SOTI on the whole depends upon the outcome of the home-phase, further research is needed to document the safety and efficacy of this portion of the treatment. Before SOTI can be applied on a widespread scale, the most suitable protocol must be developed, in order to reduce the frequency of adverse reactions. In fact, the available data on the follow-up of home phase SOTI refer to limited series, with low specific IgE levels and a short-term follow-up.⁷^,⁸^,⁹ The main aim of this study is to outline, after an hospital induction phase of SOTI,¹⁰ the adverse reactions and their treatment during the home phase of SOTI as experienced by a large series of patients diagnosed with severe CM allergy (high levels of specific IgE, recent systemic reactions, associated risk factors such as the presence of asthma) over a long follow-up period. Aims To define the incidence, severity and treatment of adverse reactions during the home...

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Barbi, E.^a; Longo, G.^b; Berti, I.^b; Matarazzo, L.^b; Rubert, L.^b; Saccari, A.^b; Lenisa, I.^b; Ronfani, L.^c; Radillo, O.^d; Ventura, A.^b

^aEmergency Department, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, University of Trieste, Italy

^bPediatric Department, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, University of Trieste, Via dell’Istria 65/1, 34100 Trieste, Italy

^cEpidemiology and Biostatistics Unit, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, University of Trieste, Italy

^dLaboratory Medicine, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, University of Trieste, Italy