Omalizumab effectiveness in asthma-COPD overlap: Post hoc analysis of PROSPERO

• Published in: Journal of allergy and clinical immunology 2019-04, Vol.143 (4), p.1629-1633.e2
• Main Authors: Hanania, Nicola A., Chipps, Bradley E., Griffin, Noelle M., Yoo, Bongin, Iqbal, Ahmar, Casale, Thomas B.
• Format: Article
• Language: English
• Subjects: Acetylcholine receptors (muscarinic); ACT assessment; Adolescent; Adult; Aged; Aged, 80 and over; Air flow; Anti-Asthmatic Agents - therapeutic use; Asthma; Asthma - complications; Asthma - drug therapy; Body mass; Bronchodilators; Case reports; Chronic obstructive pulmonary disease; Cigarettes; Clinical outcomes; Clinical trials; Corticoids; Corticosteroids; Demographics; Epidemiology; Family medical history; Female; Humans; Immunoglobulin E; Lung diseases; Male; Middle Aged; Monoclonal antibodies; Obstructive lung disease; Omalizumab - therapeutic use; Patients; Phenotypes; Pulmonary Disease, Chronic Obstructive - complications; Pulmonary Disease, Chronic Obstructive - drug therapy; Respiratory function; Respiratory tract; Respiratory tract diseases; Smoking; Studies; Treatment Outcome; Young Adult
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2018.11.032

To the Editor: Asthma and chronic obstructive pulmonary disease (COPD) overlap (ACO), defined as the coexistence of clinical features of asthma and COPD, is common.1,2 Although ACO is heterogeneous, common subphenotypes of ACO include those with asthma who are older than 40 years with a history of smoking and/or those who have persistent, progressive, and partially reversible airflow limitation.2 Epidemiologic studies suggest that ACO is associated with higher disease burden, lower quality-of-life scores, and higher health care utilization than COPD or asthma alone.1,3 Unfortunately, patients with ACO are often excluded from asthma or COPD clinical trials, including trials for recently approved targeted asthma therapies (eg, dupilumab).4 Treatment of ACO is directed to treat symptoms and airway inflammation and typically comprises inhaled corticosteroids (ICSs) with add-on bronchodilators (long-acting beta-agonists ± long-acting muscarinic antogonists) although ACO phenotypes may be less responsive to ICSs than are patients with asthma.3 Omalizumab, a monoclonal anti-IgE antibody approved for patients (≥6 years) with moderate-to-severe allergic asthma inadequately controlled with ICSs, is not approved for patients with COPD or ACO. Efficacy of omalizumab in ACO has been suggested in case reports,5,6 but patients with ACO have also been excluded from omalizumab clinical trials. [...]well-conducted, real-life large studies might be good data sources to assess the clinical potential of omalizumab for patients with ACO. NCT01922037).7 PROSPERO, a US, multicenter, single-arm, prospective, 48-week observational study of omalizumab, examined patients 12 years or older with asthma in a real-life setting not excluded for having comorbid COPD or a current or past history of smoking cigarettes.7 In PROSPERO, demographic and clinical characteristics, medical history, medication use, and smoking history were documented at baseline. Furthermore, lung function was preserved throughout the 48 weeks of this study in the ACO cohort identified by a medical history of asthma and a medical history or self-reported diagnosis of COPD.Appendix Demographic/clinical characteristic ACO A (n = 56) Non-ACO A (n = 681) ACO B (n = 50) Non-ACO B (n = 663) Age (y) Mean ± SD 57.6 ± 10.9 49.8 ± 14.9 56.8 ± 12.6 50.0 ± 14.6 Median (min, max) 59.5 (24, 78) 50.0 (18, 100) 56.0 (23, 86) 50.0 (18, 100) Sex: female, n (%) 40 (71.4) 447 (65.6) 30 (60.0) 440 (66.4) Race, n (%) White 42 (75.0) 485 (