Real-life Efficacy of Omalizumab After 9 Years of Follow-up

Abstract

Omalizumab is frequently used as add-on treatment to inhaled corticosteroids (ICS) and long-acting β2-agonists in patients with suboptimal control of severe asthma. Patients with severe asthma will typically require chronic treatment, although due to the limited amount of data available there are still some concerns about the safety and efficacy of long-term therapy with omalizumab. Herein, in an extension of a previous 4-year study, we report disease-related outcomes of 8 patients with severe persistent allergic asthma who have been followed for a total of 9 years in a real-life setting. Both quality of life (QoL) (evaluated using the Juniper Asthma-Related QoL Questionnaire [AQLQ]) and forced expiratory volume in 1 second (FEV1) showed sustained improvement at 9 years. The median values of AQLQ and FEV1 at 4 years were 5.5 and 82.0% compared to 5.9 and 85.5%, respectively, at 9 years, which were all significantly increased from baseline. After 9 years, the mean annual number of severe exacerbations was 0.63 compared to 5 at baseline. There also appeared to be a trend toward use of a lower dose of ICS at longer follow-up times. After 9 years, there were no safety concerns for continued use of omalizumab, and no asthma-related hospitalizations or emergency department visits were documented over the last 5 years. The present analysis is the longest reported clinical follow-up of omalizumab. Long-term maintenance treatment with omalizumab for up to 9 years is associated with continued benefits in reducing symptoms, exacerbations, and medication burden without any safety concerns.

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

“…Omalizumab add-on treatment in the Czech Republic sub-population resulted in considerable reductions in the daytime and nocturnal symptoms, limitations of activities, and rescue medication use, which was comparable with results seen in the overall population of the eXpeRience registry and other real-life studies [10,11,13,[25][26][27][28][29]. There was also a considerable reduction from baseline in the number of patients on OCS maintenance therapy (n = 38) to 24 months after the treatment (n = 18) along with a 44.8% reduction in the total daily dose from 11.6 mg at baseline (prednisolone equivalent) to 6.4 mg at month 24.…”

A clinical follow‐up of omalizumab in routine treatment of allergic asthma monitored by CD‐sens

“…However, in a recently published study the additional improvement of the asthma after longer omalizumab treatment, that is, more than 16 weeks, showed that although the majority of patients responded already at 16 weeks (defined as ''fast responders'') some patients did require longer treatment that is, 24 weeks (defined as ''slow responders'') for more successful outcome [22]. Another study of omalizumab treatment efficacy on quality of life and FEV1% found that the efficacy gradually increased from baseline to 32 weeks and 4 and 9 years [23].…”

The Long-Term Omalizumab Therapy in Children with Severe Persistent Uncontrolled Asthma: Evaluation of the Outcomes According to the Data of the Hospital Patient Registry

“…Длительное непрерывное лечение омализумабом улучшает контроль над болезнью, переносимость физи-ческой нагрузки, сокращает потребность в КДБА и слу-чаи тяжелых обострений, имеет высокий профиль безо-пасности [29].…”