Safety and Quality Recommendations in Allergy Medicine (Spanish acronym, RESCAL)

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A prospective safety study of allergen immunotherapy in daily clinical practice.

BACKGROUND: Despite its clinical effectiveness, allergen immunotherapy (AIT) remains controversial because serious systemic reactions can occur during its administration. Most of the studies on the safety of AIT are retrospective and use different methods, which frequently depart from daily clinical practice. OBJECTIVE: The aim of this study was to determine risk factors for adverse reactions, especially systemic adverse reactions, produced during routine AIT administration. METHODS: We registered 5,768 consecutive doses of standardized extracts administered to 273 patients in conventional schedules, following the recommendations on safety and data collection of the European Academy of Allergology and Clinical Immunology. Of the 273 patients, 236 were asthmatics, 28 had rhinitis and 9 received immunotherapy due to Hymenoptera anaphylaxis. RESULTS: We examined 143 local reactions (2.48 % of the doses) and 145 systemic reactions (78 immediate and 67 delayed). Risk factors for developing an immediate systemic reaction were asthma severity, sensitization to molds, the most concentrated vials and a fall in peak expiratory flow of more than 15 % or an immediate systemic reaction in the previous dose. Late systemic reactions were significantly more frequent with less concentrated vials and in patients with late local reactions in the previous dose. No serious reactions were registered. CONCLUSIONS: We believe that AIT is reliable when used with strict safety protocols and administered by specialized staff. Risk factors for adverse reactions to this type of treatment can be identified and reduced by systematic data collection.

A prospective safety study of allergen immunotherapy in daily clinical practice

Background: Despite its clinical effectiveness, allergen immunotherapy (AIT) remains controversial because serious systemic reactions can occur during its administration. Most of the studies on the safety of AIT are retrospective and use different methods, which frequently depart from daily clinical practice. Objective: The aim of this study was to determine risk factors for adverse reactions, especially systemic adverse reactions, produced during routine AIT administration. Methods: We registered 5,768 consecutive doses of standardized extracts administered to 273 patients in conventional schedules, following the recommendations on safety and data collection of the European Academy of Allergology and Clinical Immunology. Of the 273 patients, 236 were asthmatics, 28 had rhinitis and 9 received immunotherapy due to Hymenoptera anaphylaxis. Results: We examined 143 local reactions (2.48 % of the doses) and 145 systemic reactions (78 immediate and 67 delayed). Risk factors for developing an immediate systemic reaction were asthma severity, sensitization to molds, the most concentrated vials and a fall in peak expiratory flow of more than 15 % or an immediate systemic reaction in the previous dose. Late systemic reactions were significantly more frequent with less concentrated vials and in patients with late local reactions in the previous dose. No serious reactions were registered. Conclusions: We believe that AIT is reliable when used with strict safety protocols and administered by specialized staff. Risk factors for adverse reactions to this type of treatment can be identified and reduced by systematic data collection (AU)

Antecedentes: La inmunoterapia con alergenos es aún controvertida para algunos grupos, a pesar de su eficacia clínica, porque puede provocar reacciones sistémicas graves durante su administración. La mayoría de estudios sobre la seguridad de la inmunoterapia con alergenos son retrospectivos y emplean diferentes metodologías, muchas veces apartados de la realidad clínica diaria. Objetivos: El ánimo de este estudio fue conocer los factores de riesgo de las reacciones adversas, especialmente sistémicas, producidas durante la administración rutinaria de inmunoterapia. Métodos: Registramos 5.768 dosis consecutivas de extractos estandarizados administrados a 273 pa- cientes con pautas convencionales, siguiendo las recomendaciones de seguridad y recogida de datos de la EAACI (European Academy of Allergology and Clinical Immunology). De todos los pacientes 236 eran asmáticos, 28 riníticos y 9 recibieron inmunoterapia por anafilaxia por Himenópteros. Resultados: Registramos 143 reacciones locales (2,48 por ciento de las dosis), y 145 reacciones sistémicas (78 inmediatas y 67 tardías). Encontramos como factores de riesgo para el desarrollo de reacciones inmediatas sistémicas: la gravedad del asma, la sensibilización a hongos, los viales mas concentrados, la caída del PEF superior al 15 por ciento en la dosis previa y la presencia de otra reacción sistémica inmediata en la dosis anterior. Las reacciones sistémicas tardías fueron significativamente mas frecuentes con los viales menos concentrados y en los pacientes con reacciones locales tardías en la dosis previa. No se produjo ninguna reacción grave. Conclusiones: Creemos que la IT es segura cuando se emplean protocolos de seguridad estrictos y es administrada por personal especializado. La recogida sistemática de datos permite conocer y reducir los factores de riesgo relacionados con las reacciones adversas a este tipo de tratamiento (AU)

Reactivity to potential cross-reactive foods in fruit-allergic patients: implications for prescribing food avoidance.

BACKGROUND: Prescribing therapeutic elimination diets in patients with fruit allergy should include recommendations on which other foods of the same family or group may be safely consumed. Evidence-based data on the management of fruit allergy are lacking; therefore, advice may vary from just avoiding the offending fruit, to overly restrictive diets of the entire botanical family. The aims of this investigation were to assess clinical reactivity to potential cross-reactive foods in fruit-allergic patients, and the implications for prescribing specific therapeutic elimination diets. METHODS: Sixty-five adults diagnosed with clinical allergy to one or more fruits were evaluated for IgE-mediated allergy to other related foods, which might share cross-reactive antigens. Those with actual allergy to some Rosaceae fruit (including peach, apple, apricot, plum, and almond) underwent skin prick testing (SPT), food-specific IgE assessment by the Pharmacia CAP-FEIA system, and oral challenges with the entire group. For those with allergy to other fruits (chestnut, melon, banana, kiwi, or avocado) immunologic and clinical reactivity to all five were evaluated. Since a number of people in the study also had proven clinically allergy to some nut or legume (peanut, sunflower seed, walnut, pistachio, or hazelnut), the reactivity to the entire set was investigated. RESULTS: Thirty-four of those tested (52%) were found to be clinically allergic to more than one fruit, so 125 allergic reactions occurred in the 65 patients. Peach, melon, kiwi, apple, and banana accounted for 72% of allergic reactions. Forty-two (65%) had sensitization to pollens, causing seasonal allergic rhinitis and/or asthma, and 18 (28%) were sensitized to latex. The 65 with IgE-mediated fruit allergy underwent 351 additional SPT and food-specific IgE determinations with potential cross-reactive foods considered in this study; 223 (64%) of these results were positive. The routine challenges with potential cross-reactive foods uncovered 18 further reactions in 14 (22%) out of 65 (to avocado in seven; apricot in three; plum in one; almond and peanut in one; banana and hazelnut in one; avocado, banana and kiwi in one). Only 8% (18/223) of positive results for SPT, or food-specific IgE levels of greater than 0.35 kU(A)/l to potential cross-reactive foods investigated in this study, were clinically relevant. CONCLUSION: Elimination diets that rely on total group avoidance, or only on the results of allergy testing, might have resulted in unnecessary restriction of 205 foods in the 65 people studied. The lack of routine oral challenges with related fruits--before prescribing dietary restriction--may have allowed 18 food reactions in one-fifth (14/65) of patients to be overlooked.

Occupational IgE-mediated allergy after exposure to lupine seed flour.

The ingestion of lupine seed flour (LSF) has been reported as a cause of allergic reactions, particularly in patients sensitized to peanut, but there is little evidence of its allergenic potential after inhalation. We sought to evaluate the clinical and immunologic reactivity to lupine in employees working with this seed flour. An occupational history was obtained in 7 subjects (median age, 35 years) working with LSF at an agricultural research center. Three subjects (1, 6, and 7) reported work-related allergy symptoms immediately after being exposed to lupine. Skin prick test results with LSF extract were positive in these 3 patients with work-related symptoms. Moreover, lupine-specific IgE antibodies were detected in subjects 6 and 7. In subject 6, the controlled exposure to LSF elicited immediate naso-ocular symptoms without changes in FEV(1). In subject 7, a bronchial provocation with LSF extract elicited an immediate fall (25%) in FEV(1). Double-blinded, placebo-controlled LSF oral challenge results were positive in subjects 6 and 7. Immunologic reactivity to other legumes was detected in subjects 6 and 7, but specific inhalation testing and oral challenge results were negative. Thus, the inhalation of lupine flour could be an important cause of allergic sensitization in exposed workers and might give rise to occupational asthma and food allergy.

Asthma and rhinitis induced by exposure to raw green beans and chards.

BACKGROUND: Although the vast majority of IgE-mediated allergic reactions to foods occurs through ingestion, a few cases of unexpected allergic reactions to foods may occur through the exposure to airborne food allergen particles. METHODS: Case reports. Skin prick tests and serum-specific IgE (CAP-FEIA) were used to identify specific IgE antibodies. Bronchial provocation tests were performed to determine the clinical relevance of inhaled exposure to raw and cooked green beans and raw chards. After demonstrating specific reactivity to them, SDS-PAGE and immunoblotting of raw and cooked green beans were carried out to identify relevant antigens. RESULTS: Three women developed bronchial asthma and rhinitis after exposure to raw green beans, and one of them also when exposed to raw chards. All women tolerated ingestion of green beans. Patients reported multiple episodes while handling these vegetables for cooking activities. Allergy to green beans and chards was demonstrated by skin testing and serum-specific IgE. Bronchial challenge test with these allergens showed positive responses to raw, but not cooked, green beans and chards. Oral food challenges with green beans (raw and cooked) and chards were negative in all patients. In order to further characterize the allergenic components of these extracts, SDS-PAGE and electroblotting studies were also performed. Immunoblots of raw and cooked green beans extract showed two IgE-binding bands with apparent molecular weights of 41.1 and 70.6 kD. Interestingly, a 47-kD IgE-binding protein was detected only in raw green bean extracts. CONCLUSIONS: We report three patients who developed asthma and rhinitis caused by exposure to raw, but not to cooked, green beans and chards in a non-occupational environment. Only minor differences of IgE reactivity between nitrocellulose-blotted raw and boiled green bean extract were found.

Occupational asthma caused by exposure to asparagus: detection of allergens by immunoblotting.

BACKGROUND: Vegetables of the Liliaceae family, such as garlic or onion, have been reported to cause occupational asthma. However, there are few data on adverse reactions to asparagus. We evaluated the role of asparagus as a cause of asthma in a patient with respiratory symptoms occurring at work (horticulture) and studied relevant allergens. METHODS: A 28-year-old man complained of rhinoconjunctivitis and asthma when harvesting asparagus at work. Eating cooked asparagus did not provoke symptoms. A positive skin test reaction was observed with raw asparagus, Alternaria alternata, and grass-pollen extracts. The methacholine test demonstrated mild bronchial hyperresponsiveness. The patient had an immediate asthmatic response after challenge with raw asparagus extract. Bronchial provocation tests with boiled asparagus, A. alternata, and control extracts were negative. Two unexposed subjects with seasonal allergic asthma did not react to the raw asparagus extract. RESULTS: The double-blind, placebo-controlled food challenge with raw asparagus was negative. Serum asparagus-specific IgE was 13.9 kU(A)/l. By SDS-PAGE immunoblot, at least six IgE-binding components, ranging from 22 to 73 kDa, were detected only in raw asparagus. CONCLUSIONS: We report a case of occupational asthma caused by asparagus inhalation, confirmed by specific bronchoprovocation. Immunoblot analysis showed that asparagus allergens are very labile and quite sensitive to heat denaturation.

Occupational asthma caused by fish inhalation.

Occupational asthma (OA) due to fish inhalation, confirmed by specific bronchial challenge (SBC), has not been described as yet in medical literature, as far as we know. We describe two patients whose asthma was induced by occupational exposure to fish and confirmed by serial measurements of PEFR and SBC. Two fish-processing workers reported asthma symptoms related to their workplace. They were skin tested with fish extracts and their sera assayed for IgE antibodies to various fish species. Nonspecific bronchial reactivity was assessed by methacholine challenge. The occupational relationship was confirmed by PEFR monitoring in working and off-work periods. SBC with fish extracts was carried out to confirm the diagnosis of OA. Skin tests with raw and cooked plaice, salmon, hake, and tuna in patient 1 and anchovy, sardine, trout, salmon, Atlantic pomfret, and sole in patient 2 were positive. Specific IgE serum antibodies were found to salmon in patient 1 and to trout, anchovy, and salmon in patient 2. PEFR measurements differed significantly (P < 0.001) between work and off-work periods for both patients. A bronchial challenge with methacholine was positive in patient 1. SBC with raw hake, salmon, plaice, and tuna extracts in patient 1 and raw salmon extract in patient 2 were all positive with an immediate response. SBC with Dermatophagoides pteronyssinus extract was entirely negative in both patients. In three asthmatic, non-fish-allergic controls, SBC with tuna, hake, salmon, and plaice were all negative. These results suggest that fish inhalation can elicit IgE-mediated occupational asthma.

Fever from caffeine.

Since childhood, a 53-year-old women had developed chills, high-grade fever, myalgia, and cephalea after the ingestion of coffee, tea, cola beverages, and some oral "antiflu" compounds. Skin prick tests performed with all the implicated substances were negative. Single-blind oral challenges with both caffeine and theophylline were positive, reproducing exactly the same clinical symptoms and fever. Oral challenge with pentoxifylline was negative. We report a case of caffeine-induced fever in which we have demonstrated cross-reactivity with theophylline, but not with pentoxifylline.