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

Abstract

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.

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

“…Of the 128 patients with SAA who applied for reimbursements for omalizumab during the study period, 124 received approval and were included in the final analysis. Among the 124 enrollees, 110 patients received omalizumab treatment for at least 10 months during the 1-year follow-up period while 14 subjects received only 4 months of omalizumab because of the administrative issue from the Taiwan NHI ( 8 ). Only 75 and 85 patients had binary results of lung function measurements and ACT scores, respectively, at enrollment and the end of the 1-year follow-up period for further investigation.…”

“…The study was conducted at TCVGH, a tertiary referral center in central Taiwan, be-tween January 2010 and January 2019, and enrolled patients diagnosed of SAA who applied for reimbursements for omalizumab from the Taiwan National Health Insurance (NHI) according to the judgment of very experienced pulmonologists and immunologists in charge of asthma management. Patients whose applications were not ap-proved were excluded from this study ( 8 ).…”

“…As detailed elsewhere ( 8 ), the investigators collected clinical data, including base-line demographics, clinical features and laboratory findings, medications related to asthma management, and co-morbidities for each participant. Moreover, the treatment outcomes of interest, including exacerbation history, usage of OCSs, spirometric data and asthma control test (ACT) scores were also recorded at baseline and the end of 1-year follow-up ( 8 ).…”

“…Omalizumab is an anti-immunoglobulin E (IgE) monoclonal antibody that reduces circulatory free IgE, and it is approved for the treatment of moderate to severe IgE-mediated asthma. The GINA recommendations suggest the use of omalizumab as add-on therapy for severe asthma owing to its noticeable impact on medical resource utilization, quality of life and beneficial treatment outcomes, including improved exacerbation rate, reduced oral corticosteroid (OCS) maintenance dose, better asthma control and improvements in lung function in both adult and pediatric patients with severe allergic asthma (SAA) (1,(3)(4)(5)(6)(7)(8)(9)(10).…”

Therapeutic Modalities for Asthma, COPD, and Pathogenesis of COVID-19: Insights from the Special Issue

“…Continuing the therapeutic theme, Huang and colleagues investigated the long-term efficacy of an anti-IgE antibody, Omalizumab, in a cohort of patients with severe allergic asthma [ 30 ]. Omalizumab comes under the class of medications called monoclonal antibodies [ 31 , 32 , 33 ].…”