scholarly journals Effect of individual allergen sensitization on omalizumab treatment outcomes in patients with severe allergic asthma determined using data from the Czech Anti-IgE Registry

2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Petr Vaník ◽  
◽  
Jakub Novosad ◽  
Olga Kirchnerová ◽  
Irena Krčmová ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Allergic Asthma ◽  
Treatment Effectiveness ◽  
Specific Ige ◽  
House Dust Mites ◽  
Severe Exacerbation ◽  
Global Evaluation ◽  
Asthma Control Test ◽  
Exacerbation Rate ◽  
Severe Allergic Asthma

Abstract Background Omalizumab is an efficient drug for patients with uncontrolled severe allergic asthma (SAA). However, little is known about the differences in omalizumab treatment outcomes among patients with different types of atopic sensitization. Here, we assessed the effect of sensitization to individual allergens or their combinations on the outcomes of anti-IgE therapy in patients with SAA. Methods We performed a post hoc analysis of data of subgroups of patients enrolled in the Czech Anti-IgE Registry (CAR). The patients were evaluated at baseline and 16 weeks and 12 months after omalizumab treatment initiation. We analyzed the dependence of primary treatment outcomes [global evaluation of treatment effectiveness (GETE) after 16 weeks of treatment, a reduction in severe exacerbation rate (ER), and an improvement in the asthma control test (ACT) result during 12 months of treatment] and secondary outcomes [a reduction in systemic corticosteroid (SCS) use, an improvement in lung functions, and a fraction of exhaled nitric oxide] of patients with SAA treated with omalizumab for 12 months on sensitization to different perennial aeroallergens. We assessed sensitization to house dust mites, molds, and pets at baseline using skin prick tests and/or specific IgE measurement (semiquantitative evaluation). We compared polysensitized patients (sensitized to all tested allergens) with monosensitized (single positivity) or partially polysensitized patients (combined positivity but not to all allergens). Results We enrolled 279 patients (58.3% women, mean age 52.9 years). Omalizumab treatment presented an 82.8% response rate (according to GETE). It significantly reduced severe asthma exacerbations and SCS use, and improved the ACT result in 161 responders. We identified a subgroup of responders with distinct sensitization patterns (polysensitization to all tested perennial allergens) with higher odds of being responders (OR = 2.217, p = 0.02) and lower tendency to improve ACT result (OR 0.398, p = 0.023) and reduce ER (OR 0.431, p = 0.034) than non-polysensitized patients. Conclusions The clinical benefit of sensitization for patients with SAA receiving omalizumab may be particularly dependent on sensitization pattern. Polysensitized patients showed a higher tendency to be responders (GETE), but a lower tendency to improve the ACT result and reduce ER than non-polysensitized patients.

Clinical Experience with Anti-IgE Monoclonal Antibody (Omalizumab) In Paediatric Severe Allergic Asthma – A Romanian Perspective

2021 ◽  
Author(s):  
Berghea Elena Camelia ◽  
Mihaela Balgradean ◽  
Carmen Pavelescu ◽  
Catalin Cirstoveanu ◽  
Claudia Toma ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Lung Function ◽  
Allergic Asthma ◽  
Asthma Control ◽  
Immunoglobulin E ◽  
Real Life ◽  
First Year ◽  
Severe Exacerbation ◽  
Exacerbation Rate ◽  
Severe Allergic Asthma

Background: Asthma is the most common chronic disease affecting children and altering their quality of life. The severity of asthma is often modulated by immunoglobulin E (IgE)-mediated allergen sensitization and is associated with comorbid allergic dis-eases. Omalizumab is a humanized monoclonal antibody anti-IgE, the first biological therapy approved to treat patients aged ≥6 years with severe allergic asthma. The primary objective of our study was to investigate the efficacy and safety of Omali-zumab in Romanian paediatric patients with severe allergic asthma. Methods: In this observational real-life study, 12 children aged 6 to 18 years, (mean age 12.4 years ) with severe allergic asthma received Omalizumab as an add-on treatment. The levels of asthma control, exacerbations, lung function and adverse events were evaluated at baseline and after the first year of treatment. Results: We noticed general improvements in total asthma symptom scores and the rate of exacerbation of severe asthma. Omalizumab increased the initial variables of lung function, and no serious adverse reactions were reported. FEV1 improved statistically significant after one year of treatment with Omalizumab, [ΔFEV1 (% pred.) =18.3, and similarly, ΔMEF50 (%) = 25.8]. The mean severe exacerbation rates due to asthma decreased from 4.1 (2.8 SD) to 1.15 (0.78 SD) during the treatment year (p<0.0001) with Omalizumab. Conclusions: Treatment with Omalizumab can be an effective and safe therapeutic option for Romanian children with severe allergic asthma, providing clinically relevant in-formation on asthma control and exacerbation rate in children and adolescents. The results highlighted the effect of Omalizumab in young patients, starting from the first year of treatment.

scholarly journals Clinical Experience with Anti-IgE Monoclonal Antibody (Omalizumab) in Pediatric Severe Allergic Asthma—A Romanian Perspective

Children ◽  
2021 ◽  
Vol 8 (12) ◽  
pp. 1141
Author(s):  
Elena Camelia Berghea ◽  
Mihaela Balgradean ◽  
Carmen Pavelescu ◽  
Catalin Gabriel Cirstoveanu ◽  
Claudia Lucia Toma ◽  
...  
Keyword(s):  
Lung Function ◽  
Children And Adolescents ◽  
Allergic Asthma ◽  
Asthma Control ◽  
Immunoglobulin E ◽  
Real Life ◽  
First Year ◽  
Severe Exacerbation ◽  
Exacerbation Rate ◽  
Severe Allergic Asthma

Background: Asthma is the most common chronic disease affecting children, with a negative impact on their quality of life. Asthma is often associated with comorbid allergic diseases, and its severity may be modulated by immunoglobulin E (IgE)-mediated allergen sensitization. Omalizumab is a humanized monoclonal anti-IgE antibody, the first biological therapy approved to treat patients aged ≥6 years with severe allergic asthma. The primary objective of our study was to investigate the efficacy and safety of Omalizumab in Romanian children with severe allergic asthma. Methods: In this observational real-life study, 12 children and adolescents aged 6 to 18 years (mean 12.4 years) with severe allergic asthma received Omalizumab as an add-on treatment. Asthma control, exacerbations, lung function, and adverse events were evaluated at baseline and after the first year of treatment. Results: We observed general improvement in total asthma symptom scores and reduction in the rate of exacerbation of severe asthma. Omalizumab treatment was associated with improvement in the measures of lung function, and no serious adverse reactions were reported. FEV1 improved significantly after one year of treatment with Omalizumab [ΔFEV1 (% pred.) = 18.3], and [similarly, ΔMEF50 (%) = 25.8]. The mean severe exacerbation rate of asthma decreased from 4.1 ± 2.8 to 1.15 ± 0.78 (p < 0.0001) during the year of treatment with Omalizumab. Conclusions: This study showed that Omalizumab can be an effective and safe therapeutic option for Romanian children and adolescents with severe allergic asthma, providing clinically relevant information on asthma control and exacerbation rate in children and adolescents. The results demonstrated the positive effect of Omalizumab in young patients with asthma, starting from the first year of treatment.

Real-World Data Evaluation Of Total IgE, Specific IgE And Omalizumab Therapy In A Cohort Of Allergic Asthma Patients Treated In A Community-Based Practice

2020 ◽  
Author(s):  
Fortune O Alabi
Keyword(s):  
Allergic Asthma ◽  
Specific Ige ◽  
Forced Expiratory Volume ◽  
Act Scores ◽  
Asthma Control Test ◽  
Real World Data ◽  
Total Ige ◽  
Prick Test ◽  
Negative Results ◽  
Asthma Patients

Objective: In this study, we: (1) evaluated the correlation between total IgE and the presence of specific IgE; (2) compared the characteristics of patients with positive specific IgE to those with negative specific IgE; and, (3) analyzed the allergic testing results of patients on omalizumab and reported the effect of omalizumab on forced expiratory volume (FEV1) and asthma control test (ACT) results. Methods: Data from patients diagnosed with allergic asthma and seen at Florida Lung, Asthma & Sleep Specialists (FLASS) between January 2016 and June 2019 were analyzed. Parameters evaluated were total IgE, and levels of specific IgE to antigens in the ImmunoCAP test and skin prick test (SPT). Additional parameters for patients on omalizumab therapy for at least 6 months were FEV1, % predicted FEV1 and ACT results. Results: A total of 475 patients (114 males, 361 females) met the inclusion criteria. The mean age was 53 years (range: 17 to 89 years). Of these, 36 patients were not included in the analysis due to incomplete data. Mean total IgE was higher in patients with positive ImmunoCAP results compared to those with negative results (396 KU/L vs. 81.3 KU/L). There was a significant positive correlation between total IgE and levels of positive specific IgE in the ImmunoCAP test (p<0.0001, r=0.36, n=213 patients). The correlation between total IgE and levels of positive allergens in SPT was not significant (p=0.15, n=44 patients) Two positive reactions to allergens were seen in 22% of ImmunoCAP tests and 13% of SPT tests. There was no statistically significant improvement in FEV1 (p=0.097, CI -0.17 to 0.02) and % predicted FEV1 (p=0.109, CI -6.63 to 0.70) in patients who used omalizumab for at least 6 months. There was a statistically significant improvement in ACT scores (p=0.031, CI -4.21 to -0.21) in patients who used omalizumab for at least 6 months. Conclusion: Allergic asthma could be seen in patients who had an absence of specific IgE in ImmunoCAP and a negative reaction to SPT. The benefit of omalizumab therapy is not limited to allergic asthma patients with positive specific IgE.

scholarly journals Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study

2018 ◽  
Vol 51 (5) ◽  
pp. 1702523 ◽  
Author(s):  
Marc Humbert ◽  
Camille Taillé ◽  
Laurence Mala ◽  
Vincent Le Gros ◽  
Jocelyne Just ◽  
...  
Keyword(s):  
Allergic Asthma ◽  
Eosinophil Count ◽  
Response Rate ◽  
Real Life ◽  
Blood Eosinophil ◽  
Exacerbation Rate ◽  
Blood Eosinophil Count ◽  
Life Study ◽  
Severe Allergic Asthma ◽  
Blood Eosinophils

Omalizumab is a monoclonal anti-IgE antibody used to treat severe allergic asthma (SAA). The aim of the STELLAIR study was to determine the importance of pre-treatment blood eosinophil count as a predictive measure for response to omalizumab.This retrospective real-life study was conducted in France between December 2015 and September 2016 using medical records of SAA omalizumab-treated patients. Response to omalizumab was assessed by three criteria: physician evaluation, reduction of ≥40% in annual exacerbation rate and a combination of both. Response rate was calculated according to blood eosinophil count measured in the year prior to omalizumab initiation.872 SAA omalizumab-treated patients were included by 78 physicians (723 adults (age ≥18 years) and 149 minors (age 6–17 years)). Blood eosinophil count was ≥300 cells·µL−1 in 52.1% of adults and 73.8% of minors. By physician evaluation, 67.2% of adults and 77.2% of minors were responders and 71.1% adults and 78.5% minors had a ≥40% reduction in the exacerbation rate. In adults, the response rate for combined criteria was 58.4% (95% CI 53.2–63.4%) for blood eosinophils ≥300 cells·µL−1 (n=377) and 58.1% (95% CI 52.7–63.4%) for blood eosinophils <300 cells·µL−1 (n=346).This study shows that a large proportion of patients with SAA have a blood eosinophil count ≥300 cells·µL−1, and suggests that omalizumab effectiveness is similar in “high” and “low” eosinophil subgroups.

Sensitivity in allergic asthmatic subjects towards house dust mite allergens

2021 ◽  
Vol 26 (1) ◽  
pp. 75-84
Author(s):  
Amandeep Kaur Dhaliwal ◽  
Devinder Singh ◽  
Ramanpreet Kaur Randhawa ◽  
Atinderpal Singh
Keyword(s):  
Allergic Asthma ◽  
House Dust ◽  
House Dust Mite ◽  
Specific Ige ◽  
Mite Species ◽  
House Dust Mites ◽  
Total Serum ◽  
Dust Mites ◽  
Allergic Asthmatic ◽  
Dust Mite

Asthma is a common problem that affects about 20 million peoples in India and can be often under-diagnosed or misdiagnosed. It can be allergic or non-allergic though the former type is more common and prevalent. Allergic asthma can be triggered by many allergens and house dust mites (HDM) are one of the common indoor allergens. The present study emphasizes the significance of house dust mites in allergic asthmatic subjects which is based on 115 asthmatic subjects in Punjab, India. For the quantification and the estimation of total serum Immunoglobulin E and HDM specific IgE, a mixture of 14 allergens and a mixture of two mite allergens viz. Dermatophagoides pteronyssinus and D. farinae were used respectively. Total and specific IgE levels were detected on ImmunoCAP Phadia 100. A statistically significant correlation between total and HDM specific IgE levels of 115 asthmatic subjects was found as compared to control group of 30 non-allergic individuals. The specific IgE levels of 54.78% subjects against the allergen of two mite species were found to be positive. Dust samples were taken from various localities of the houses to identify the diversity of house dust mites which were responsible for allergic asthma. Five common house dust mite species viz. D. pteronyssinus Trouessart, D. farinae Hughes, D. microceras Griffiths and Cunnington, D. aureliani Fain and Euroglyphus maynei Cooreman were identified from the dust. The present study observed that total IgE levels were higher with higher specific IgE levels against the mixture of two mite allergens viz. D. pteronyssinus and D. farinae in the blood serum.  D. pteronyssinus was the most abundant and prevalent mite species followed by D. farinae. Therefore, present study concluded that HDM specific IgE levels against the mite allergen of D. pteronyssinus and D. farinae in the serum of allergic asthmatic subjects were found to be higher because of the higher prevalence of these two mites (D. pteronyssinus i.e. 69.80% and D. farinae i.e. 20.72%) in the house of allergic asthmatic subjects as compared to other identified mites.

scholarly journals IL-8, IL-10, TGF-β, and GCSF Levels Were Increased in Severe Persistent Allergic Asthma Patients with the Anti-IgE Treatment

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Arzu D. Yalcin ◽  
Atil Bisgin ◽  
Reginald M. Gorczynski
Keyword(s):  
Healthy Volunteers ◽  
Allergic Asthma ◽  
Persistent Asthma ◽  
High Sensitivity ◽  
Specific Ige ◽  
Th2 Cells ◽  
Newly Diagnosed ◽  
Asthma Control Test ◽  
Cytokine Levels ◽  
Asthma Patients

Background. Allergic asthma is showed an increase in Th2-cytokine and IgE levels and an accumulation activation of Th2 cells, eosinophils and mast cells. However, recent studies focused on cell-based mechanisms for the pathogenesis of allergic asthma.Objectives. In this study, we compare the anti-IgE treatment modality in the dynamics of immune system cytokine levels in severe persistent asthma (SPA) patients who had no other any allergic disease, newly diagnosed allergic asthma patients and healthy volunteers.Study Design. The study population consisted of 14 SPA patients, 14 newly diagnosed allergic asthma patients and 14 healthy volunteers included as controls. Cytokine levels were measured. Total and specific IgE levels of anti-IgE monoclonal antibody treated patients, serum high-sensitivity C-reactive protein (hsCRP) levels, FEV1/FVC rates and asthma control test (ACT) were measured for the clinical follow-up.Results. We observed that SPA patients presented increasing levels of IL-8, IL-10, TGF-βand GCSF during the anti-IgE treatment in period of sampling times at 4 months and 18 months. However this increase was not correlated neither with serum hsCRP levels nor FEV1/FVC rates.Conclusions. Our study gives a different perspective for the SPA and anti-IgE immunotherapy efficacy at the cell cytokine-linked step.

scholarly journals The Long-Term Effectiveness of Omalizumab in Adult Patients with Severe Allergic Asthma: Continuous Treatment Versus Boosting Treatment

2021 ◽  
Vol 10 (4) ◽  
pp. 707
Author(s):  
Wei-Chang Huang ◽  
Pin-Kuei Fu ◽  
Ming-Cheng Chan ◽  
Chun-Shih Chin ◽  
Wen-Nan Huang ◽  
...  
Keyword(s):  
Allergic Asthma ◽  
Small Airway ◽  
Adult Patients ◽  
Continuous Treatment ◽  
Asthma Control Test ◽  
Airway Function ◽  
Severe Allergic Asthma ◽  
Forced Expiratory Flow

The implications of boosting Omalizumab treatment (OT) in patients with severe allergic asthma (SAA) remain unclear. The study aimed to explore and compare the 12-month effectiveness between continuous, at least 10-month OT (continuation group) and four-month boost of Omalizumab (boost group) in adult patients with SAA. In this retrospective cohort study, clinical data were collected for further analysis. Of all participants (n = 124), a significant reduction in annual exacerbations (baseline = 0.8 ± 1.5, follow-up = 0.5 ± 1.0, p = 0.047 *) and improvement in small airway ventilation as evaluated by forced expiratory flow at 25–75% (baseline = 55.1 ± 11.1%, follow-up = 59.4 ± 8.4%, p < 0.001 *) were found in the continuation group (n = 110). By contrast, the boost group (n = 14) had significantly increased annual exacerbations (baseline = 0.7 ± 1.4, follow-up = 2.9 ± 3.6, p = 0.031 *) and impaired small airway function (baseline = 55.3 ± 12.9, follow-up = 52.1 ± 12.5, p = 0.026 *). Furthermore, the continuation group rather than the boost group had significant decreases in the frequency of oral corticosteroid (OCS) use as controllers (baseline = 32.7%, follow-up = 20.0%, p = 0.047 *; baseline = 50.0%, follow-up = 21.4%, p = 0.237, respectively) and OCS maintenance dose (mg/month) (baseline = 85.9 ± 180.8, follow-up = 45.8 ± 106.6, p = 0.020 *; baseline = 171.4 ± 221.5, follow-up = 50.0 ± 104.3, p = 0.064, respectively), and increases in asthma control test scores (baseline = 16.0 ± 3.0, follow-up = 19.8 ± 4.4, p < 0.001 *; baseline = 14.6 ± 3.8, follow-up = 19.7 ± 4.7, p = 0.050, respectively). Continuous OT would be beneficial for adult patients with SAA, while boost of Omalizumab would worsen their long-term outcomes.

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