Follow-up after discontinuation of omalizumab in patients with moderate-to-severe asthma: A systematic review.

Abstract

Background: Omalizumab is a well-established add-on therapy for patients with moderate-to-severe asthma. However, there is limited systematic evidence on the long-term outcomes after discontinuation of this treatment. Objective: To address this evidence gap, this review aimed to systematically evaluate the follow-up outcomes in patients with moderate-to-severe asthma after discontinuation of omalizumab treatment. Methods: The research was conducted in accordance with the systematic reviews and meta-analyses guidelines. We systematically searched medical literature data bases from December 2003 to August 2025 for observational studies (prospective or retrospective) on omalizumab discontinuation in moderate-to-severe asthma. Data extraction was conducted on key variables: omalizumab treatment regimens, postdiscontinuation long-term outcomes, asthma control status, relapse risk factors, asthma exacerbation rates, corticosteroid use, and patterns of omalizumab reinitiation. Results: A total of 11 eligible studies were included in the review. After discontinuation, most patients showed no remarkable changes in forced expiratory volume in 1 second, fractional exhaled nitric oxide level, total immunoglobulin E value, or absolute eosinophil count. Moreover, no obvious deterioration was observed in patient-reported quality of life. These findings confirm the sustained long-term benefits of previous omalizumab add-on therapy because the majority of patients maintained favorable disease control after discontinuation. Subgroup analyses further indicated that asthma exacerbations, when they occurred, predominantly occurred within the first year after discontinuation. Conclusion: This review indicates that, although most patients maintain stable objective indicators after omalizumab discontinuation, a significant proportion are at increased risk for exacerbations, deterioration in asthma control, and increased corticosteroid use, particularly within the first year.