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 ◽  
...  

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 <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 [<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 <300 cells/μL (<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.

Author(s):  
Berghea Elena Camelia ◽  
Mihaela Balgradean ◽  
Carmen Pavelescu ◽  
Catalin Cirstoveanu ◽  
Claudia Toma ◽  
...  

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.


Children ◽  
2021 ◽  
Vol 8 (12) ◽  
pp. 1141
Author(s):  
Elena Camelia Berghea ◽  
Mihaela Balgradean ◽  
Carmen Pavelescu ◽  
Catalin Gabriel Cirstoveanu ◽  
Claudia Lucia Toma ◽  
...  

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.


2021 ◽  
Vol 10 (4) ◽  
pp. 707
Author(s):  
Wei-Chang Huang ◽  
Pin-Kuei Fu ◽  
Ming-Cheng Chan ◽  
Chun-Shih Chin ◽  
Wen-Nan Huang ◽  
...  

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.


2019 ◽  
Vol 4 ◽  
pp. 168 ◽  
Author(s):  
Harriet Mpairwe ◽  
Pius Tumwesige ◽  
Milly Namutebi ◽  
Marble Nnaluwooza ◽  
Tonny Katongole ◽  
...  

Background: Children from low- and middle-income countries have poor asthma control, mainly because of poor management. The extent of this problem in Uganda is not well known, but such information would be useful to guide policy and practice. We therefore conducted a cross-sectional study among schoolchildren with asthma in urban Uganda, to assess the level of asthma control and management. Methods: Schoolchildren aged 5-17 years were enrolled, asthma was diagnosed by the study medical team. Asthma control was assessed using the Asthma Control Test and the childhood Asthma Control Test. Data on previous asthma management was obtained using interviewer-led questionnaires. Data were analysed using multiple linear and multiple logistic regression. Results: We enrolled 561 children with asthma, of whom only 56% had ever had an asthma diagnosis. We categorised asthma as well-controlled (55.5%), partly-controlled (29.5%) and poorly-controlled (15.0%). Poor asthma control was associated with increasing age (adjusted regression coefficient [95% confidence interval], p-value: -1.07 [-1.20, -0.94], p<0.0001), concurrent allergic rhinitis (-1.33 [-2.28, -0.38], p=0.006), and city residence in early life (-1.99 [-3.69, -0.29], p=0.06). Regular use of inhaled asthma medication in the last 12 months was very low; 18.1% for salbutamol and 6.7% for inhaled corticosteroids. The main barriers to inhaled asthma medication use were lack of prescription (47.6%) and inaccurate diagnosis (38.8%). Increased inhaler use was associated with tertiary education of the fathers (adjusted odds ratio [95% confidence interval], p-value: 5.19 [2.39-11.28], p<0.0001), city residence in early life (4.66 [1.79-12.43], 0.002) and an asthma diagnosis prior to enrolment (11.39 [6.35-20.43], p<0.0001). Conclusions: This study confirms that children with asthma in Uganda generally have inadequate asthma control, which is attributable to poor asthma management. This could be improved through re-training of medical workers and patient education, and by increasing availability and affordability of essential asthma medications.


2018 ◽  
Vol 75 (5) ◽  
pp. 378-381 ◽  
Author(s):  
Orianne Dumas ◽  
Raphäelle Varraso ◽  
Krislyn M Boggs ◽  
Alexis Descatha ◽  
Paul K Henneberger ◽  
...  

ObjectivesTo investigate the association between occupational exposure to disinfectants/antiseptics used for hand hygiene and asthma control in nurses.MethodsIn 2014, we invited female nurses with asthma drawn from the Nurses’ Health Study II to complete two supplemental questionnaires on their occupation and asthma (cross-sectional study, response rate: 80%). Among 4055 nurses (mean age: 59 years) with physician-diagnosed asthma and asthma medication use in the past year, we examined asthma control, as defined by the Asthma Control Test (ACT). Nurses were asked about the daily frequency of hand hygiene tasks: ‘wash/scrub hands with disinfectants/hand sanitizers’ (hand hygiene) and ‘wash/scrub arms with disinfecting products’ (surrogate of surgical hand/arm antisepsis). Analyses were adjusted for age, race, ethnicity, smoking status and body mass index.ResultsNurses with partly controlled asthma (ACT: 20–24, 50%) and poorly controlled asthma (ACT ≤19, 18%) were compared with nurses with controlled asthma (ACT=25, 32%). In separate models, both hand and arm hygiene were associated with poorly controlled asthma. After mutual adjustment, only arm hygiene was associated with poorly controlled asthma: OR (95% CI) for <1 time/day, 1.38 (1.06 to 1.80); ≥1 time/day, 1.96 (1.52 to 2.51), versus never. We observed a consistent dose–response relationship between frequency of arm hygiene tasks (never to >10 times/day) and poor asthma control. Associations persisted after further adjustment for surfaces/instruments disinfection tasks.ConclusionsFrequency of hand/arm hygiene tasks in nurses was associated with poor asthma control. The results suggest an adverse effect of products used for surgical hand/arm antisepsis. This potential new occupational risk factor for asthma warrants further study.


2020 ◽  
Vol 124 (2) ◽  
pp. 190-196 ◽  
Author(s):  
William W. Busse ◽  
Marc Humbert ◽  
Tmirah Haselkorn ◽  
Benjamin Ortiz ◽  
Benjamin L. Trzaskoma ◽  
...  

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