ArticleJournal of asthma and allergy2022
Efficacy and Safety of Omalizumab Treatment Over a 16-Year Follow-Up: When a Clinical Trial Meets Real-Life.
Article in Journal of asthma and allergy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The efficacy and safety of omalizumab in the treatment of asthma: an overview of systematic reviews and meta analyses.Frontiers in medicine · 2025Pooled it
- Individualized precision therapy for severe asthma: clinical applications of biological agents and frontiers of cell therapy.Frontiers in immunology · 2026Review
- Biologic Therapy in Severe Asthma: A Phenotype-Driven and Targeted Approach.Journal of clinical medicine · 2025Review
- Managing Urticarial Vasculitis: A Clinical Decision-Making Algorithm Based on Expert Consensus.American journal of clinical dermatology · 2025Review
- Characteristics of Older Individuals with Asthma Being Treated with Biologics.Journal of asthma and allergy · 2025Article
- Tezepelumab for early-onset severe allergic asthma with persistent airflow limitation and small airway dysfunction: a treatable traits approach.Drugs in context · 2025Article
- Anti-IgE therapy in chronic rhinosinusitis with nasal polyps.The Journal of allergy and clinical immunology · 2025Review
- Difficult-To-Treat and Severe Asthma: Can Real-World Studies On Effectiveness of Biological Treatments Change the Lives of Patients?Pragmatic and observational research · 2024Review
- Factors influencing poor response to type 2 targeted therapies in severe asthma: a retrospective cohort study.BMC pulmonary medicine · 2023Article
- Switching Biological Therapies in Severe Asthma.International journal of molecular sciences · 2023Review
- Therapeutical Targets in Allergic Inflammation.Biomedicines · 2022Review
- Comparison between clinical trials and real-world evidence studies on biologics for severe asthma.The Journal of international medical research · 2022Review
- Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study.ERJ open research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Treatment of severe asthma has made great strides thanks to rapid progress in understanding immune response and inflammatory pathways. This led to the advent of the first biologic for severe allergic asthma (SAA), omalizumab. Although the long-term efficacy and safety of omalizumab has been confirmed, increasingly longer follow-up data can further reinforce this evidence and potentially provide new ones, for example on any loss of efficacy or the appearance of unexpected side effects. This study reports omalizumab treatment-related outcomes after 16 years of follow-up. Patients and Methods: In this real-life retrospective study, an extension of a previous 9-year follow-up study on patients initially recruited in a clinical trial, we enrolled 8 adult patients with SAA followed-up from November 2005 to December 2021. Study subjects were selected based on omalizumab eligibility criteria. Results: Exacerbation rate significantly decreased from 3.6 ± 2.1 events in year before index date to 0.1 ± 0.4 after 32 weeks of treatment (p < 0.0001). Mean annual number of mild-to-moderate exacerbations at 16 years was 0.88 compared with 1.8 in the year before the index date and 1.1 at 32 weeks. No hospitalizations were documented during the 16-year follow-up compared to 0.3 hospitalizations/patient in the year before the index date. Respiratory function also progressively and significantly improved. Regarding patient-reported outcomes (PROs), The AQLQ and ACT significantly improved from baseline throughout the follow-up, particularly up to 9 years of follow-up. During the study, an overall reduction in doses of asthma medications was observed, with a significant OCS-sparing effect. Conclusion: Our study, the longest clinical follow-up on patients treated with anti-IgE, confirms and amplifies the results of the studies carried out so far, as they are maintained over a very long interval of time without drops in efficacy without any type of side effect.
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