Safety and predictors of adverse events during oral immunotherapy for milk allergy: severity of reaction at oral challenge, specific IgE and prick test
M Vazquez‐Ortiz, M Alvaro‐Lozano… - Clinical & …, 2013 - Wiley Online Library
M Vazquez‐Ortiz, M Alvaro‐Lozano, L Alsina, MB Garcia‐Paba, M Piquer‐Gibert…
Clinical & Experimental Allergy, 2013•Wiley Online LibraryBackground Strict avoidance is the only accepted management for cow's milk (CM) allergy.
CM oral immunotherapy (CM‐OIT) is under investigation. Objectives To evaluate long‐term
safety of CM‐OIT. To identify clinical/immunological predictors of adverse events. Methods
Prospective longitudinal epidemiological intervention study. CM‐allergic children aged 5–18
underwent a Spanish‐approved CM‐OIT protocol without premedication. Clinical data, skin
prick test (SPT) and specific IgE (sIgE) at baseline and 1 year after OIT were registered. All …
CM oral immunotherapy (CM‐OIT) is under investigation. Objectives To evaluate long‐term
safety of CM‐OIT. To identify clinical/immunological predictors of adverse events. Methods
Prospective longitudinal epidemiological intervention study. CM‐allergic children aged 5–18
underwent a Spanish‐approved CM‐OIT protocol without premedication. Clinical data, skin
prick test (SPT) and specific IgE (sIgE) at baseline and 1 year after OIT were registered. All …
Background
Strict avoidance is the only accepted management for cow's milk (CM) allergy. CM oral immunotherapy (CM‐OIT) is under investigation.
Objectives
To evaluate long‐term safety of CM‐OIT. To identify clinical/immunological predictors of adverse events.
Methods
Prospective longitudinal epidemiological intervention study. CM‐allergic children aged 5–18 underwent a Spanish‐approved CM‐OIT protocol without premedication. Clinical data, skin prick test (SPT) and specific IgE (sIgE) at baseline and 1 year after OIT were registered. All dose‐related reactions, treatments needed and cofactors involved were recorded. Through survival analysis, we studied the cumulative probability of reactions resolution over time and clinical/immunological risk factors of reactions persistence.
Results
81 children were recruited. Mean follow‐up was 25 months. 95% of children suffered reactions, 91% of which affected a single organ. Reactions were heterogeneously distributed: (a) 60 children (75%) had occasional symptoms which ceased over time. 86% of them reached complete desensitization (200 mL). (b) 20 children (25%) suffered frequent (78% of total reactions), more severe and unpredictable reactions, which persisted during follow‐up or led to withdrawal (6 cases). Reactions persistence was associated with a higher frequency and severity. Kaplan–Meier estimate revealed a cumulative probability of reactions resolution of 25% at 3 months (95% CI: 1.9–4.1) and 50% (95% CI: 6.1–9.9) at 8 months based on all patients. Cox proportional hazards multivariate regression model identified 3 variables (CM‐sIgE ≥ 50 KU L−1, CM‐SPT ≥ 9 mm and Sampson's severity grades 2, 3 and 4 at baseline food challenge) as independent risk factors of reactions persistence. The combination of 2 or 3 of these factors involved hazard ratios to develop persistent reactions of 2.26 (95% CI: 1.14–4.46; P = 0.019) and 6.06 (95% CI: 2.7–13.7; P < 0.001), respectively.
Clinical implications
CM‐OIT was insufficiently safe in 25% of children. The above‐mentioned clinical and immunological parameters would help clinicians to identify highly reactive patients before CM‐OIT. In them, individualized schedules and premedication should be considered.
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