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Consumer Attitudes Towards Packaged Foods Having Food Allergen Advisory Labeling
Abstracts AB127
J ALLERGY CLIN IMMUNOL VOLUME 137, NUMBER 2
Early Peanut OIT-Induced Suppression of Basophil Reactivity Is a Marker of Sustained Unresponsiveness
Sarita U. Patil, MD1,2, Johanna Steinbrecher, BS3, Alex Ma, BS4,5, Neal Smith, BS6, Cecilia Washburn, BS6, Alanna Hickey7, Caroline Southwick7, Lauren Tracy7, Bert Ruiter, PhD8, Yamini Virkud, MD, MA, MPH2, Michael Schneider9, Wayne Shreffler, MD, PhD10,11; 1Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 2 Department of Allergy and Immunology, Massachusetts General Hospital, Boston, MA, 3Department of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Charlestown, MA, 4New York University College of Dentistry, New York, NY, 5Massachusetts General Hospital, Charlestown, MA, 6Department of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Charlestown, MA, 7 Food Allergy Center, Massachusetts General Hospital, Boston, MA, 8 Massachusetts General Hospital, Boston, MA, 9BUHLMANN Laboratories AG, Basel, Switzerland, 10Division of Allergy and Immunology, Department of Pediatrics, Massachusetts General Hospital and Harvard Medical School, Boston, MA, 11Harvard Medical School, Boston, MA. RATIONALE: Peanut allergic subjects undergoing oral immunotherapy may or may not achieve a sustained clinical benefit. Biomarkers to identify those at risk for regaining allergic reactivity after active treatment are needed. METHODS: Twenty-three peanut allergic children, aged 7-13 underwent PNOIT in a single-center, open-label trial. In those with challenge-proven desensitization after a 14-20 month-long protocol (n522), sustained unresponsiveness was confirmed by DBPCFC after one month of peanut avoidance in 9 patients. Peripheral blood from multiple time points was stimulated in vitro (Arah1, Arah2, Arah6, whole peanut extract, antiFcεRI) and basophil activation, based on upregulation of CD63, was assessed by flow cytometry. A data-driven analysis pipeline utilizing R/ Bioconductor was created to derive summary statistics and analyses. RESULTS: Basophil reactivity is suppressed by one month into desensitization (CD63 logAUC: Arah2 298.1 vs 28.8 p<0.001, whole peanut 432.1 vs 26.9 p<0.001) among all patients and partially rebounds after 1 month of post treatment avoidance (Arah2 138.2, whole peanut 208.6). Although basophil reactivity was similar at baseline between patients who achieved sustained unresponsiveness (SU) versus those with transient desensitization (TD) (Arah2 p50.5, whole peanut p50.6), it was more significantly suppressed in SU patients by 1 month of PNOIT treatment (Arah2 p<0.001, whole peanut p<0.001) and that difference persisted through the desensitization phase (p<0.05). Furthermore, the post avoidance rebound of basophil reactivity was significantly less for SU patients to both Arah2 (p50.03) and peanut (p50.02) stimulation. CONCLUSIONS: Basophil suppression one month after initiation of peanut immunotherapy may be an early biomarker for sustained unresponsiveness.
420
Peanut Allergen Thresholds in Israel – a ''Low Peanut Allergy'' Prevalence Area
Tamar Yichie, BScNutr, RD1, Michael R. Goldberg, MD, PhD1, Michael B. Levy, MD, FAAAAI1, Liat Nachshon, MD1, Keren Golobov, BScNutr RD1, Arnon Elizur, MD1,2, Yitzhak Katz, MD, FAAAAI1,2; 1Assaf Harofeh Medical Center, Zerifin, Israel, 2Department of Pediatrics, Sackler School of Medicine, Tel Aviv, Israel. RATIONALE: Early introduction of peanut-based snacks to infants in Israel is implicated in the lower prevalence rate of peanut allergy in Israel as compared to the UK (0.17% versus 1.7%, respectively). It was of import, therefore, to determine whether these different feeding regimens would impact also on the lowest observed adverse effect level (LOAEL), in contrast to the currently pooled data worldwide. METHODS: A retrospective analysis of oral food challenge (OFC) results of patients with a clinical history of peanut allergy and a positive skin prick
_ 3 mm wheal) and/or patients enrolled in a peanut oral immunotest (> therapy (OIT) program was performed. A physician-supervised OFC was administered starting with a dose of 0.1 mg of peanut protein followed by subsequent dose escalations, until a reaction occurred. RESULTS: OFCs were performed in 137 patients (ages 10 months to 35 years, median 7 years), the majority of which (115/137) entered our OIT program. 15/137 (10.9%) reacted at 5 mg or less and 68/137 (49.6%) reacted at 25 mg or less. The lowest observed adverse effect level (LOAEL) value was 1.25 mg (n53) and the no-observed adverse effect level (NOAEL) was 1 mg (n5137). No subjects were left-censored. CONCLUSIONS: The LOAEL found in patients in Israel, a country with a lower peanut allergy prevalence rate is significantly higher than values published in worldwide pooled data. These data if confirmed suggest that NOAEL established in countries with ‘‘high’’ peanut allergy prevalence may be utilized universally.
421
Consumer Attitudes Towards Packaged Foods Having Food Allergen Advisory Labeling
Catherine A. Mills, Julie Wang, MD, FAAAAI, Jacob D. Kattan, MD; Icahn School of Medicine at Mount Sinai, New York, NY. RATIONALE: While foods with advisory labeling (eg, ‘‘may contain’’) have been shown to contain detectable levels of food allergens, it was reported 10 years ago that allergic patients were increasingly disregarding the warnings. We sought to determine whether consumers with food allergy are heeding advisory labels, if they view different formats of the labeling statement as having different risks, and reasons why they may not be avoiding these products. METHODS: Surveys (n5504) were conducted at our university-based, outpatient practice; subjects reported allergies to peanut (365), tree nuts (404), milk (150), egg (167), wheat (49), soy (46), finned fish (48) and/or shellfish (81). RESULTS: Overall, 55.7% of subjects report avoidance of products with advisory labels. Among subjects with peanut allergy, the number was slightly higher (59.6%). 107 (21.5%) subjects reported an allergic reaction thought to be due to cross-contamination in a product bearing an advisory label. Among participants not avoiding products with advisory labels, the most commonly cited reasons for disregarding the labels were ‘‘I believe there is unlikely to be any allergen in these products’’ (45.0%) and ‘‘They are very hard to avoid because so many products have these labels’’ (46.8%). Subjects were significantly less likely to heed a label that starts ‘‘manufactured in a facility that also’’ (36.6%) than ‘‘may contain’’ (66.5%, p<0.001). CONCLUSIONS: Consumers with food allergy are increasingly disregarding advisory labeling despite a high rate of suspected allergic reactions to these products. While previous reports indicate some level of risk with any advisory statement, consumers continue to interpret these labels differently.
SUNDAY
419
J ALLERGY CLIN IMMUNOL VOLUME 137, NUMBER 2
Early Peanut OIT-Induced Suppression of Basophil Reactivity Is a Marker of Sustained Unresponsiveness
Sarita U. Patil, MD1,2, Johanna Steinbrecher, BS3, Alex Ma, BS4,5, Neal Smith, BS6, Cecilia Washburn, BS6, Alanna Hickey7, Caroline Southwick7, Lauren Tracy7, Bert Ruiter, PhD8, Yamini Virkud, MD, MA, MPH2, Michael Schneider9, Wayne Shreffler, MD, PhD10,11; 1Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 2 Department of Allergy and Immunology, Massachusetts General Hospital, Boston, MA, 3Department of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Charlestown, MA, 4New York University College of Dentistry, New York, NY, 5Massachusetts General Hospital, Charlestown, MA, 6Department of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Charlestown, MA, 7 Food Allergy Center, Massachusetts General Hospital, Boston, MA, 8 Massachusetts General Hospital, Boston, MA, 9BUHLMANN Laboratories AG, Basel, Switzerland, 10Division of Allergy and Immunology, Department of Pediatrics, Massachusetts General Hospital and Harvard Medical School, Boston, MA, 11Harvard Medical School, Boston, MA. RATIONALE: Peanut allergic subjects undergoing oral immunotherapy may or may not achieve a sustained clinical benefit. Biomarkers to identify those at risk for regaining allergic reactivity after active treatment are needed. METHODS: Twenty-three peanut allergic children, aged 7-13 underwent PNOIT in a single-center, open-label trial. In those with challenge-proven desensitization after a 14-20 month-long protocol (n522), sustained unresponsiveness was confirmed by DBPCFC after one month of peanut avoidance in 9 patients. Peripheral blood from multiple time points was stimulated in vitro (Arah1, Arah2, Arah6, whole peanut extract, antiFcεRI) and basophil activation, based on upregulation of CD63, was assessed by flow cytometry. A data-driven analysis pipeline utilizing R/ Bioconductor was created to derive summary statistics and analyses. RESULTS: Basophil reactivity is suppressed by one month into desensitization (CD63 logAUC: Arah2 298.1 vs 28.8 p<0.001, whole peanut 432.1 vs 26.9 p<0.001) among all patients and partially rebounds after 1 month of post treatment avoidance (Arah2 138.2, whole peanut 208.6). Although basophil reactivity was similar at baseline between patients who achieved sustained unresponsiveness (SU) versus those with transient desensitization (TD) (Arah2 p50.5, whole peanut p50.6), it was more significantly suppressed in SU patients by 1 month of PNOIT treatment (Arah2 p<0.001, whole peanut p<0.001) and that difference persisted through the desensitization phase (p<0.05). Furthermore, the post avoidance rebound of basophil reactivity was significantly less for SU patients to both Arah2 (p50.03) and peanut (p50.02) stimulation. CONCLUSIONS: Basophil suppression one month after initiation of peanut immunotherapy may be an early biomarker for sustained unresponsiveness.
420
Peanut Allergen Thresholds in Israel – a ''Low Peanut Allergy'' Prevalence Area
Tamar Yichie, BScNutr, RD1, Michael R. Goldberg, MD, PhD1, Michael B. Levy, MD, FAAAAI1, Liat Nachshon, MD1, Keren Golobov, BScNutr RD1, Arnon Elizur, MD1,2, Yitzhak Katz, MD, FAAAAI1,2; 1Assaf Harofeh Medical Center, Zerifin, Israel, 2Department of Pediatrics, Sackler School of Medicine, Tel Aviv, Israel. RATIONALE: Early introduction of peanut-based snacks to infants in Israel is implicated in the lower prevalence rate of peanut allergy in Israel as compared to the UK (0.17% versus 1.7%, respectively). It was of import, therefore, to determine whether these different feeding regimens would impact also on the lowest observed adverse effect level (LOAEL), in contrast to the currently pooled data worldwide. METHODS: A retrospective analysis of oral food challenge (OFC) results of patients with a clinical history of peanut allergy and a positive skin prick
_ 3 mm wheal) and/or patients enrolled in a peanut oral immunotest (> therapy (OIT) program was performed. A physician-supervised OFC was administered starting with a dose of 0.1 mg of peanut protein followed by subsequent dose escalations, until a reaction occurred. RESULTS: OFCs were performed in 137 patients (ages 10 months to 35 years, median 7 years), the majority of which (115/137) entered our OIT program. 15/137 (10.9%) reacted at 5 mg or less and 68/137 (49.6%) reacted at 25 mg or less. The lowest observed adverse effect level (LOAEL) value was 1.25 mg (n53) and the no-observed adverse effect level (NOAEL) was 1 mg (n5137). No subjects were left-censored. CONCLUSIONS: The LOAEL found in patients in Israel, a country with a lower peanut allergy prevalence rate is significantly higher than values published in worldwide pooled data. These data if confirmed suggest that NOAEL established in countries with ‘‘high’’ peanut allergy prevalence may be utilized universally.
421
Consumer Attitudes Towards Packaged Foods Having Food Allergen Advisory Labeling
Catherine A. Mills, Julie Wang, MD, FAAAAI, Jacob D. Kattan, MD; Icahn School of Medicine at Mount Sinai, New York, NY. RATIONALE: While foods with advisory labeling (eg, ‘‘may contain’’) have been shown to contain detectable levels of food allergens, it was reported 10 years ago that allergic patients were increasingly disregarding the warnings. We sought to determine whether consumers with food allergy are heeding advisory labels, if they view different formats of the labeling statement as having different risks, and reasons why they may not be avoiding these products. METHODS: Surveys (n5504) were conducted at our university-based, outpatient practice; subjects reported allergies to peanut (365), tree nuts (404), milk (150), egg (167), wheat (49), soy (46), finned fish (48) and/or shellfish (81). RESULTS: Overall, 55.7% of subjects report avoidance of products with advisory labels. Among subjects with peanut allergy, the number was slightly higher (59.6%). 107 (21.5%) subjects reported an allergic reaction thought to be due to cross-contamination in a product bearing an advisory label. Among participants not avoiding products with advisory labels, the most commonly cited reasons for disregarding the labels were ‘‘I believe there is unlikely to be any allergen in these products’’ (45.0%) and ‘‘They are very hard to avoid because so many products have these labels’’ (46.8%). Subjects were significantly less likely to heed a label that starts ‘‘manufactured in a facility that also’’ (36.6%) than ‘‘may contain’’ (66.5%, p<0.001). CONCLUSIONS: Consumers with food allergy are increasingly disregarding advisory labeling despite a high rate of suspected allergic reactions to these products. While previous reports indicate some level of risk with any advisory statement, consumers continue to interpret these labels differently.
SUNDAY
419