Observational studyBMJ open2016
Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: a UK multicentre observational study (the APEX II study).
Observational study in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
28 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- The Clinical and Economic Impact of Biologic Agents in Asthma Management: a Systematic Review.Lung · 2026Pooled it
- Predictors of Response to Biologics for Severe Asthma: A Systematic Review and Meta-Analysis.Allergy · 2026Pooled it
- Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence.International journal of molecular sciences · 2021Pooled it
- Systematic Literature Review of Systemic Corticosteroid Use for Asthma Management.American journal of respiratory and critical care medicine · 2020Pooled it
- Omalizumab and long-term quality of life outcomes in patients with moderate-to-severe allergic asthma: a systematic review.Therapeutic advances in respiratory diseasePooled it
- Can we predict who will benefit most from biologics in severe asthma? A post-hoc analysis of two phase 3 trials.Respiratory research · 2023Trial
- Comparative effectiveness of omalizumab in asthma-COPD overlap vs. asthma: a retrospective cohort study.Frontiers in medicine · 2026Article
- Targeted Biologic Therapies in Severe Asthma: Mechanisms, Biomarkers, and Clinical Applications.Pharmaceuticals (Basel, Switzerland) · 2025Review
- LMAN1 is a receptor for house dust mite allergens.Cell reports · 2023Article
- Article
- Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab.Tuberkuloz ve toraks · 2023Observational
- Roles of real-world evidence in severe asthma treatment: challenges and opportunities.ERJ open research · 2023Article
- The "real-world" effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study.Postepy dermatologii i alergologii · 2023Article
- Effects of biological therapies on patients with Type-2 high asthma and comorbid obesity.Frontiers in pharmacology · 2023Review
- Real-life Effectiveness of Omalizumab in Patients with Severe Allergic Asthma: RELIEF Study.The open respiratory medicine journal · 2022Article
- Use of Biologic Therapies in the Treatment of Asthma - A Comparative Real World Data Analysis on Healthcare Resource Utilization and Costs Before and After Therapy Initiation.Journal of asthma and allergy · 2022Article
- Efficacy and Safety of Omalizumab Treatment Over a 16-Year Follow-Up: When a Clinical Trial Meets Real-Life.Journal of asthma and allergy · 2022Article
- Real-world experience of the clinical effectiveness of omalizumab use in Qatar - a study protocol.Qatar medical journal · 2022Article
- Long-term corticosteroid use, adrenal insufficiency and the need for steroid-sparing treatment in adult severe asthma.Journal of internal medicine · 2021Review
- Saudi Arabian real-life experience with biologic therapy in severe asthma.Multidisciplinary respiratory medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo describe the impact of omalizumab on asthma management in patients treated as part of normal clinical practice in the UK National Health Service (NHS).
designA non-interventional, mixed methodology study, combining retrospective and prospective data collection for 12 months pre-omalizumab and post-omalizumab initiation, respectively.
settingData were collected in 22 UK NHS centres, including specialist centres and district general hospitals in the UK.
participants258 adult patients (aged ≥16 years; 65% women) with severe persistent allergic asthma treated with omalizumab were recruited, of whom 218 (84.5%) completed the study. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was change in mean daily dose of oral corticosteroids (OCS) between the 12-month pre-omalizumab and post-omalizumab initiation periods. A priori secondary outcome measures included response to treatment, changes in OCS dosing, asthma exacerbations, lung function, employment/education, patient-reported outcomes and hospital resource utilisation.
resultsThe response rate to omalizumab at 16 weeks was 82.4%. Comparing pre-omalizumab and post-omalizumab periods, the mean (95% CIs) daily dose of OCS decreased by 1.61 (-2.41 to -0.80) mg/patient/day (p<0.001) and hospital exacerbations decreased by 0.97 (-1.19 to -0.75) exacerbations/patient (p<0.001). Compared with baseline, lung function, assessed by percentage of forced expiratory volume in 1 s, improved by 4.5 (2.7 to 6.3)% at 16 weeks (p<0.001; maintained at 12 months) and patient quality of life (Asthma Quality of Life Questionnaire) improved by 1.38 (1.18 to 1.58) points at 16 weeks (p<0.001, maintained at 12 months). 21/162 patients with complete employment data gained employment and 6 patients lost employment in the 12-month post-omalizumab period. The mean number of A&E visits, inpatient hospitalisations, outpatient visits (excluding for omalizumab) and number of bed days/patient decreased significantly (p<0.001) in the 12-month post-omalizumab period.
conclusionsThese data support the beneficial effects of omalizumab on asthma-related outcomes, quality of life and resource utilisation in unselected patients treated in 'real-world' clinical practice.
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