Efficacy of omalizumab treatment for pediatric chronic spontaneous urticaria: A multi-center retrospective case series.

BACKGROUND: Chronic urticaria is defined by the presence of itchy wheals, sometimes accompanied by angioedema, lasting for at least 6 weeks. In children, most cases occur without an eliciting factor and are defined as chronic spontaneous urticaria (CSU). CSU affects up to 0.75% of children with a negative impact on quality of life and school performance. CSU is treated in adults with second-generation antihistamines, increased up to four times normal doses for second-line treatment. Omalizumab (a monoclonal antibody to IgE) may be recommended as third-line therapy. A similar protocol is used in children, yet little is known of its efficacy and safety. OBJECTIVES: To summarize our multi-center experience in treating children with recalcitrant CSU with omalizumab. METHODS: A retrospective multi-center case series conducted in 5 tertiary care centers in Israel. Patients included were children <18 years old diagnosed with recalcitrant CSU who were treated with omalizumab. Patients were followed up throughout the duration of omalizumab therapy/symptom remission. Patients' electronic medical records were used to gather data. RESULTS: Nineteen participants (11 F; 8 M) presented with CSU between ages 6 and 16.9 years. Sixteen (84%) responded to omalizumab, including children <12 years old, although two became non-responsive after 6-12 months of therapy. Another three patients (16%) were resistant to treatment, achieving remission through fourth-line (Cyclosporine A) or other therapies. CONCLUSION: Children with recalcitrant CSU, even those <12 years old, respond well to standard-dose, third-line omalizumab therapy at rates similar to adults. Yet, some cases may become non-responsive with ongoing treatment.

[THE SERUM LEVELS OF MILK AND PEANUT-SPECIFIC IGE: ROLE IN THE EVALUATION OF THE RISK FOR ALLERGIC REACTION IN CHILDREN IN ISRAEL].

BACKGROUND: The performance characteristics of the ImmunoCAP assay for detecting specific IgE antibodies in the evaluation of milk and peanut allergy have been established. However, the results are not comparable to the IMMULITE 2000, another FDA-approved assay available in Israel, owing to differences in the extracts used, technical method, and population studied. OBJECTIVES: To establish the performance characteristics and predictive values for the IMMULITE 2000 assay in Israel. METHODS: The database of the Allergy Clinic at Schneider Children's Medical Center in Israel was searched for all patients referred for evaluation of allergies in 2006-2009. The results of the milk- and peanut-specific IgE antibody tests were collected and correlated with the clinical diagnoses of milk and peanut allergy or tolerance. Sensitivity, specificity and positive and negative predictive values were calculated as well as receiver operating characteristic (ROC) plots. RESULTS: The prevalence of milk allergy was 30% (111/369 patients), and peanut allergy, 6% (31/505 patients). The area under the ROC curve was 0.954 for milk allergy and 0.956 for peanut allergy. The levels with a positive predictive value of ≥95% were 10 kU/L and 3 kU/L, respectively. The level of peanut-specific IgE antibodies with a ≥95% positive predictive value was lower than found for the ImmunoCAP in the USA and Europe. CONCLUSIONS: These findings indicate that the decision points used for predicting the risk of future allergic reactions must be calculated separately for different assay methods and different populations. Our findings may assist the allergists in Israel to decide whether to perform a supervised oral challenge in order to verify if the patient has developed tolerance to milk or peanuts.

Effect of instruction on the ability to use a self-administered epinephrine injector.

BACKGROUND: Patients with allergy as well as their parents frequently fail to use the self-administered epinephrine injection (EpiPen) properly in cases of allergic emergencies. OBJECTIVES: To determine the benefit of an instruction session with follow-up instruction. METHODS: We evaluated 141 patients aged 1.9-23.4 years (median 5.8 years, 83% with food allergy) or their parents (for those aged < 12 years) who were trained in the use of the EpiPen during the first diagnostic visit to the allergy clinic during 2006-2009. At the next follow-up visit, the patients or their parents were asked to list the indications for epinephrine administration and to demonstrate the five steps involved in using the EpiPen. Each step was scored on a scale of 0-2. RESULTS: Fourteen participants (9.9%) had used self-injectable epinephrine in the past. Only 65 (46%) brought the device with them to the follow-up visit. The mean total score for the whole sample was 4.03 +/- 3. Fifty-three participants (38%) failed to remove the cap before trying to apply the device. Only 8 (5.6%) had a maximum score. The patients and their parents were reinstructed in the use of the device: 41 participants were reexamined at a subsequent follow-up visit after 1.02 +/- 0.56 years; their mean score improved from 4.71 +/- 3.04 to 6.73 +/- 3.18 (P < 0.001). CONCLUSIONS: Patients with severe allergic reactions, as well as their parents, are not sufficiently skilled in the use of the EpiPen after only one instruction session with a specialist. Repeated instruction may improve the results and we therefore recommend that the instructions be repeated at every follow-up visit.

Selective IgA deficiency in children in Israel.

IgA deficiency is the most common human primary immune-deficiency. We evaluated the clinical and immunological characteristics of selective IgA deficiency in children in Israel. The study group included 63 children diagnosed with IgA deficiency from 1987 to 2005. Mean follow-up time per child was 10.6 years. Average age at diagnosis was 10.5 years. In one child, the IgA deficiency was transient. Infectious diseases, mainly recurrent pneumonia and ear infection, were common and occurred in 25 patients (39.7%). Allergic diseases were documented in 20 (31.7%) of our patients. Thirteen children (20.6%) had autoimmune diseases. Malignancies were diagnosed in three children (4.8%), an association that has not been reported in previous series. IgA deficiency appears to be a risk factor for infections, allergic diseases, autoimmune conditions, and malignancy.

Trends in adrenaline (EpiPen) dispensing in Israel in 1997-2004.

BACKGROUND: The prevalence of allergic diseases has increased over the last 20 years in the Western world. Reports on the growing use of adrenaline auto-injectors (EpiPen and EpiPen Jr) in several countries may point to increased rates of anaphylactic reactions, increased awareness of the risk of anaphylaxis or both. OBJECTIVES: To evaluate the dispensing rate of EpiPen units in Israel from 1997 to 2004. METHODS: The database of the General Health Services (Clalit) was searched to determine the number of EpiPen units dispensed each year from 1997 to 2004. Data on mortality from anaphylaxis were derived from the Central Bureau of Statistics using International Classification of Diseases, 10th revision codes. RESULTS: The dispensing rate of EpiPen units rose gradually from 1689 in 1997 to 2981 in 2004; an overall increase of 76%. No case of death from anaphylaxis was reported from 1998 to 2000. CONCLUSIONS: The dispensing rate of adrenaline auto-injectors has increased considerably over the last 8 years in Israel, although to a lesser degree than in other countries. This is probably a reflection of updated medical policies, in accordance with the clinical guidelines for the management of anaphylaxis and improved public education. Further studies are needed to determine the prevalence of anaphylactic reactions in Israel.