Effectiveness of omalizumab in children and adolescents with uncontrolled allergic asthma: a case series from Poland.

INTRODUCTION: Omalizumab has been successfully used as a supplementary therapy to improve asthma control in children aged ≥ 6 years with moderate or severe persistent allergic asthma. AIM: To evaluate effectiveness ofomalizumab in children and adolescents with uncontrolled allergic asthma. MATERIAL AND METHODS: Seventeen children and adolescents aged 8-16, treated with omalizumab from 2011 until now, were enrolled into the retrospective, open, uncontrolled, observational study. The effectiveness of therapy, asthma control, quality of life, exacerbation rate, corticosteroid use, were assessed after 16, 52 and 104 weeks of treatment and after omalizumab cessation. RESULTS: The response to treatment was assessed as excellent (9 patients) and good (6 patients), according to global evaluation of treatment effectiveness (GETE). A statistically significant decrease in use of oral corticosteroids (OCS) and leukotriene receptor antagonists (LTRAs) was observed. The doses of inhaled corticosteroids (ICS) decreased significantly (the mean dose of ICS converted to a dose of budesonide before treatment was 1503.53 µg/day versus 903.53 µg after discontinuation). The mean asthma control questionnaire (ACQ) value decreased from 2.10 to 0.84 points and the mean mini asthma quality of life questionnaire (miniAQLQ) outcome increased from 4.37 to 6.1 points. The mean number of exacerbations decreased from 5.59 to 0.53 per year. CONCLUSIONS: Our results are supportive of the existing evidence that omalizumab therapy improves asthma control, reduces OCS and ICS use, decreases exacerbations in children and adolescents with severe/moderate uncontrolled allergic asthma.

Quality of life in asthmatic children and their caregivers after two-year treatment with omalizumab, a real-life study.

INTRODUCTION: Omalizumab, a monoclonal anti-immunoglobulin E antibody, has been successfully used as a supplementary therapy to improve asthma control in children aged ≥ 6 years with severe persistent allergic asthma. AIM: To demonstrate the quality of life in children with severe asthma and their caregivers, and changes from baseline in forced expiratory volume in 1 s (FEV1) and daily inhaled corticosteroids (ICS) dose after 2-year treatment with omalizumab. MATERIAL AND METHODS: Participants were seen in the clinic at enrollment (visit 1), after 16 weeks (visit 2), after 52 weeks (visit 3) and after 104 weeks (visit 4) of treatment with omalizumab. We evaluated lung function, ICS use and the quality of life with the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). RESULTS: Nineteen children and caregivers were enrolled. Significant improvement was observed in PAQLQ and PACQLQ scores, both in all domains and in total scores. Significant differences were found between the first and the other visits. A positive correlation between PAQLQ and PACQLQ at the first and at the second visit was found, 63.3% of patients achieved reduction in ICS doses. We did not notice any significant improvement in FEV1. CONCLUSIONS: The improvement in quality of life in asthmatic children and adolescents observed after omalizumab correlates with the improvement of quality of life in caregivers, reduction in ICS use but not with FEV1.

Serum tryptase level and inflammatory markers in exhaled breath condensate of children with exercise-induced symptoms.

BACKGROUND: The pathogenesis of exercise-induced bronchoconstriction (EIB) is poorly understood. OBJECTIVE: To evaluate the biomarkers concentration in exhaled breath condensate (EBC) in schoolchildren with postexercise symptoms. We also evaluated changes in fractional exhaled nitric oxide (FeNO) value and the serum tryptase level after exercise. METHODS: One hundred children with postexercise symptoms were included. Methacholine challenge testing (MCT) was performed at visit 2, and exercise challenge testing (ECT) was performed at visit 3. Before and after ECT serum tryptase levels and FeNO values were measured. EBC was collected after ECT from 10 randomly selected children from each group. The children were assigned to the following groups: ECT(+) MCT(+), ECT(+) MCT(-), ECT(-) MCT(+), ECT(-) MC(-). We measured the following molecules: eotaxin, interleukin (IL) 8, IL-1ra, IL-1 beta, IL-6, IL-1 alpha, IL-12(p40), IL-5, granulocyte-macrophage colony-stimulating factor, IL-7, IL-15, IL-4, IL-2, IL-10, tumor necrosis factor alpha, interferon gamma, IL-13, tumor necrosis factor beta, monocyte chemoattractant protein-1, IL-17A, macrophage inflammatory proteins-1 alpha, macrophage inflammatory proteins-1 beta, IL-12(p70), and regulated on activation, normal T-cell expressed and secreted by using a multiplex immunoassay. Prostaglandin E2 (PGE2), leukotriene B4, and cysteinyl leukotriene were analyzed by using separate enzyme-linked immunosorbent assay kits. RESULTS: In the MCT(+) group, a detectable level of IL4 in EBC and detectible levels of eicosanoids were seen in the ECT(+) group. We observed the opposite direction of ECT-induced changes in FeNO and serum tryptase concentrations in patients with detectable compared with patients without detectable levels of cytokines in EBC. We showed ECT-induced reduction in the tryptase level in patients with a nondetectable PGE2 level in EBC and an increase in tryptase levels in patients who had detectable levels of PGE2 in EBC. CONCLUSIONS: EBC was a useful method to estimate inflammation but only in children with symptoms and with EIB shown by a positive ECT. Children with a positive ECT had detectable levels of eicosanoids in EBC; the opposite direction of ECT-induced changes in FeNO and serum tryptase concentrations was observed. The results of above study confirm the role of mast cells and eicosanoids in the pathogenesis of EIB in children.

[Exercise-induced urticaria and angioedema - case report]. / Pokrzywka powysilkowa i obrzek naczynioruchowy - opis przypadku.

Urticaria is a heterogeneous group of disorders, with various clinical manifestations and intensity of symptoms. Urticaria can be induced with a wide variety of environmental stimuli, such as cold, pressure, vibration, sunlight, exercise, temperature changes, heat, and water. In a select group of patients, exercise can induce a spectrum of urticaria symptoms, ranging from cutaneous pruritus and warmth, generalised urticaria, angioedema, and the appearance of such additional manifestations as collapse, upper respiratory distress, and anaphylaxis. Specific provocation tests should be carried out on an individual basis to investigate the suspected cause and proper diagnosis. Modification of activities and behaviour is the mainstay of treatment in patients with physical urticaria. The aim of this study was to emphasise that primary care paediatricians should be able to recognise physical urticaria, supply a patient with rescue medications, and refer him/her to a specialist. In the article, the authors present a 13-year-old girl with typical urticaria lesions and angioedema after exercise. According to the history, physical examination, and provocation test, exercise-induced urticaria and angioedema were diagnosed.

Omalizumab as a new therapeutic approach for children with severe asthma.

Omalizumab has been shown to improve asthma control when added to a regimen of guideline-based therapy for inner-city children and adolescents, nearly eliminating seasonal peaks in exacerbation and reducing the need for other medications to control asthma. Below, we describe a case of a 17-year-old non-smoker with a history of severe asthma admitted to our clinic after unsuccessful 10-year immunotherapy. The patient fulfilled the criteria for anti-IgE therapy, he was prescribed omalizumab 600 mg every 2 weeks. During therapy he was able to reduce his use of ICS and did not require any oral corticosteroids. He experienced an increase in his ability to exercise and noted no exacerbation of asthma symptoms. It is possible that in our patient, specific immunotherapy could be successfully continued after the initiation of omalizumab therapy.

Omalizumab in the prevention of anaphylaxis during immunotherapy: a case report.

Omalizumab is approved for the treatment of chronic severe persistent asthma. As a trigger for anaphylaxis, the frequency of subcutaneous specific immunotherapy (SCIT) is high. We report the case of a 11-year-old boy with severe allergic asthma. During the initial phase of immunotherapy he experienced anaphylaxis and SCIT was discontinued. Because of uncontrolled asthma, despite the inhaled steroids and ß-agonists were taken into consideration, omalizumab 300 mg once every 4 weeks was initiated. Currently, the maintenance dose has been reached and SCIT is continued without any side effects. The clinical implication of the above case report is that children with severe allergic asthma who are pre-treated with omalizumab might also benefit in the future from SIT as a causal treatment option.