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.

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.

Long-term efficacy and safety of omalizumab in patients with allergic asthma: A real-life study

2021 ◽  
Vol 42 (3) ◽  
pp. 235-242 ◽  
Author(s):  
Andriana I. Papaioannou ◽  
Myrto Mplizou ◽  
Konstantinos Porpodis ◽  
Evangelia Fouka ◽  
Eleftherios Zervas ◽  
...  
Keyword(s):  
Lung Function ◽  
Adverse Events ◽  
Allergic Asthma ◽  
Asthma Control ◽  
Real Life ◽  
Efficacy And Safety ◽  
Life Study ◽  
Long Term Treatment ◽  
Real Life Study

Background: The efficacy and safety of omalizumab in patients with severe allergic asthma have been established in both randomized controlled trials and real-life studies. Objective: To evaluate the sustained effectiveness and safety of long-term treatment with omalizumab in a real-world setting. Methods: In this retrospective study, we included patients treated with omalizumab for at least 8 years in four asthma clinics in Greece. Pulmonary function, asthma control, oral corticosteroids (OCS) dose, and exacerbations were recorded before treatment, 6 months later, and annually thereafter. Adverse events were also recorded. Results: Forty-five patients (66.7% women), mean ± standard deviation (SD) age 55.3 ± 12.2 years, were included. The duration of treatment with omalizumab was 10.6 ± 1.2 years. The annual exacerbation rate decreased from 4.1 before omalizumab initiation to 1.1 after 1 year of treatment and remained low up to the 8th year of treatment (p < 0.001). From the 19 patients who were receiving OCS at baseline, 21.1% patients discontinued after 6 months, 47.4% were still on OCS after 4 years of therapy, and 31.6% were on OCS after 8 years. With regard to the OCS dose, 36.8% of the patients reduced the dose ≥ 50% after 6 months and 68.4% achieved 50% reduction after 2 years. The mean daily OCS dose before omalizumab initiation was 7.8 mg of prednisolone or the equivalent, reduced to 4.7 mg/day after 6 months, which reached 1.6 mg/day after 8 years (p < 0.001). Treatment with omalizumab resulted in significant improvements of asthma control and lung function. No severe adverse events were reported. Conclusion: In this real-life study, omalizumab resulted in significant and sustained improvements in asthma exacerbations, asthma control, and lung function, and had a steroid sparing effect and a good safety profile.

scholarly journals Predictors of a Minimal Clinically Important Difference Following Omalizumab Treatment in Adult Patients With Severe Allergic Asthma

2022 ◽  
Vol 8 ◽  
Author(s):  
Wei-Chang Huang ◽  
Pin-Kuei Fu ◽  
Ming-Cheng Chan ◽  
Chun-Shih Chin ◽  
Wen-Nan Huang ◽  
...  
Keyword(s):  
Lung Function ◽  
Allergic Asthma ◽  
Asthma Control ◽  
Minimal Clinically Important Difference ◽  
Adult Patients ◽  
Blood Eosinophil ◽  
Asthma Control Test ◽  
Cross Sectional ◽  
Clinically Important Difference ◽  
Severe Allergic Asthma

Several factors have been found to be predictors of a good response following omalizumab treatment in patients with severe allergic asthma (SAA). However, it remains unclear whether clinical characteristics can predict a minimal clinically important difference (MCID) following omalizumab treatment in this population. Therefore, the aim of this study was to investigate the features associated with an MCID following omalizumab treatment in adult patients with SAA. Of the 124 participants enrolled in this retrospective, cross-sectional study, 94, 103, 20 and 53 achieved the MCID following treatment with omalizumab and were considered to be responders of exacerbation reduction (no exacerbation during the 1-year follow-up period or ≧50% reduction in exacerbations from baseline), oral corticosteroid (OCS) sparing (no use of OCS to control asthma during the study period or a reduction of the monthly OCS maintenance dose to &lt;50% of baseline), lung function (an increase of ≧230 ml in the forced expiratory volume in 1 s from baseline) and asthma control (an increase of ≧3 points in the asthma control test score from baseline), respectively. Normal weight [&lt;25 vs. ≧30 kg/m2, odds ratio (OR) = 3.86, p = 0.024] was predictive of a responder of reduction in exacerbations following omalizumab treatment while subjects with a blood eosinophil level of &lt;300 cells/μL (&lt;300 vs. ≧300 cells/μL, OR = 5.81, p = 0.001) were more likely to exhibit an MCID in OCS sparing. No factor was found to be a predictor of lung function or asthma control. When choosing treatment for adult patients with SAA, our findings may help to select those who may benefit the most from omalizumab treatment.

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.

Asthma control and exacerbation rate with omalizumab in Italian patients with severe allergic asthma: PROXIMA study

2017 ◽  
Author(s):  
Caterina Bucca ◽  
Paola Rottoli ◽  
Bruno Macciocchi ◽  
Cristiano Caruso ◽  
Riccardo Polosa ◽  
...  
Keyword(s):  
Allergic Asthma ◽  
Asthma Control ◽  
Exacerbation Rate ◽  
Severe Allergic Asthma

scholarly journals Immunologic Pathophysiology and Airway Remodeling Mechanism in Severe Asthma: Focused on IgE-Mediated Pathways

Diagnostics ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 83
Author(s):  
Shih-Lung Cheng
Keyword(s):  
Severe Asthma ◽  
Immunoglobulin E ◽  
Airway Remodeling ◽  
Real Life ◽  
Allergic Diseases ◽  
Proinflammatory Mediators ◽  
Small Subgroup ◽  
Humanized Monoclonal Antibody ◽  
Severe Allergic Asthma ◽  
Ige Mediated

Despite the expansion of the understanding in asthma pathophysiology and the continual advances in disease management, a small subgroup of patients remains partially controlled or refractory to standard treatments. Upon the identification of immunoglobulin E (IgE) and other inflammatory mediators, investigations and developments of targeted agents have thrived. Omalizumab is a humanized monoclonal antibody that specifically targets the circulating IgE, which in turn impedes and reduces subsequent releases of the proinflammatory mediators. In the past decade, omalizumab has been proven to be efficacious and well-tolerated in the treatment of moderate-to-severe asthma in both trials and real-life studies, most notably in reducing exacerbation rates and corticosteroid use. While growing evidence has demonstrated that omalizumab may be potentially beneficial in treating other allergic diseases, its indication remains confined to treating severe allergic asthma and chronic idiopathic urticaria. Future efforts may be bestowed on determining the optimal length of omalizumab treatment, seeking biomarkers that could better predict treatment response and as well as extending its indications.

Omalizumab discontinuation in children with severe allergic asthma: An observational real‐life study

Allergy ◽  
2019 ◽  
Vol 74 (5) ◽  
pp. 999-1003 ◽  
Author(s):  
Antoine Deschildre ◽  
Juliette Roussel ◽  
Elodie Drumez ◽  
Rola Abou‐Taam ◽  
Cinthia Rames ◽  
...  
Keyword(s):  
Allergic Asthma ◽  
Real Life ◽  
Life Study ◽  
Severe Allergic Asthma ◽  
Real Life Study
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