Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial

Abstract

Background: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. Methods: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV₁, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. Results: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. Conclusion: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good.

Influence of prolonged treatment with omalizumab on the development of solid epithelial cancer in patients with atopic asthma and chronic idiopathic urticaria: A systematic review and meta‐analysis

“…General characteristics of the twelve included studies that reported on study‐emergent solid epithelial cancer are summarized in Tables and . Additional details can be found in Appendix .…”

“…Collectively, these studies included a total of 11 758 participants and encompassed three study types. Three were RCTs, one was a comparative observational study (prospective cohort), and eight were non‐comparative observational studies . Their publication dates ranged from 2002 to 2018; however, 75% were published in the last 5 years.…”

“…Eight other observational studies were non‐comparative longitudinal studies that evaluated outcomes in a group of participants sampled on the basis of a single exposure (ie all subjects received omalizumab). Four studies (67%) were prospective, two were registry studies, and five were completed at a single centre.…”

“…Four studies (67%) were prospective, two were registry studies, and five were completed at a single centre. One study was funded by Novartis Pharmaceuticals, two studies were funded by both Genentech Inc and Novartis Pharmaceuticals, three declared no funding, and the others did not report on study funding.…”

Recent Advances in Clinical Allergy and Immunology

“…Despite the fact that biologic material is used to produce the allergen extracts, the standardized production process guarantees high quality and minimal variance between batches [7]. Omalizumab, which has been approved for the treatment of asthma, has excellent short- and long-term effects on asthma outcomes, such as asthma exacerbation and hospitalization rates, as well as with an asthma control test over a period of 5 years [8]. Targeting eosinophils by blocking IL-5 or its receptor is a novel approach for asthma treatment.…”