title: Eligibility for treatment with omalizumab in Italy and Germany.
abstract: Omalizumab is an add-on therapy for patients with uncontrolled severe allergic asthma. In Europe, patients must fulfil a number of additional criteria to become eligible for omalizumab therapy, creating a challenge for epidemiology studies to quantify the potential patient pool. Thus, and in the absence of robust data, the number of omalizumab-eligible patients has remained unclear. To assess eligible patient numbers, a chart-audit design approach was employed to measure epidemiology variables based on patient-level data. 770 patient charts were reviewed in designated towns in Germany and Italy, in collaboration with >200 primary care physicians (PCPs) and respiratory specialists (RS). This study sample represents >50% and >70% of local RS in these designated towns of Germany and Italy, respectively. Of patient charts evaluated, 4 patients were currently receiving omalizumab. A further 31 patients (12 PCP; 19 RS) were evaluated as omalizumab-eligible (i.e. fulfilled all product label criteria) but were not receiving the drug. Extrapolating to a national level, this yields >6500 eligible patients in Germany, and >3200 in Italy. Furthermore, this study sample revealed a significant number of PCPs treating uncontrolled severe asthma patients without referral to RS; these patients are not consistently evaluated for FEV1, aero-allergen sensitivity, a qualitative understanding of severe exacerbations, and day and night-time symptoms. This study suggests that significant numbers of omalizumab-naïve severe allergic asthma patients in Germany/Italy are eligible for omalizumab therapy. Despite proven benefits in uncontrolled severe allergic asthma, adjunctive omalizumab therapy is underutilized.
authors: Pulmonary Department, University Hospital, Johannes Gutenberg-University, Langenbeckstr, D-55131 Mainz, Germany.
authors: Roland
authors: R
authors: Buhl
authors: Novartis Pharma AG, 4056 Basel, Switzerland.
authors: Andrea Gili
authors: AG
authors: Marco
authors: Novartis Pharma AG, 4056 Basel, Switzerland.
authors: Daniel
authors: D
authors: Cohen
authors: Allergy and Respiratory Diseases, DIMI, University of Genoa, Largo Rosanna Benzi 10, Genoa 16132, Italy. Electronic address: canonica@unige.it.
authors: Giorgio Walter
authors: GW
authors: Canonica
mesh_terms: D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage / Q000009:adverse effects / Q000032:analysis / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000032:analysis / Q000627:therapeutic use*; D001249:Asthma / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D015415:Biomarkers / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004608:Eligibility Determination / Q000706:statistics & numerical data*; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007558:Italy / Q000453:epidemiology; D000069444:Omalizumab; D018579:Patient Selection; D015995:Prevalence; D011788:Quality of Life; D012494:Sampling Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D015415:Biomarkers; D000069444:Omalizumab; D007073:Immunoglobulin E
keywords: Allergic asthma; Anti-immunoglobulin E; Eligibility; Epidemiology