title: Asthma control in severe asthmatics under treatment with omalizumab: a cross-sectional observational study in Italy.
abstract: Few data are available on the proportion of asthmatics achieving a good asthma control (according GINA guidelines) and on the level of airway inflammation during omalizumab treatment. The aim of this cross-sectional national observational study was to assess the level of control (according to GINA guidelines) achieved in a group of asthmatics on omalizumab treatment, and to characterize the factors that influence the lack of control. We studied 306 asthmatics under omalizumab treatment for a median of 32 months (range 4-120). The level of control according to GINA was good in 25.2%, partial in 47.1% and poor in 24.5% of patients (data were missing for the remaining 3.2%). Comparison between poorly controlled and partially or well controlled asthmatics showed a statistically significant higher prevalence of some comorbidities in the first group, namely obesity, gastro-oesophageal reflux disease (GORD), aspirin intolerance and mental disorders (all p < 0.001). Similarly, asthmatics with at least one exacerbation in the last year showed a significantly higher prevalence of obesity, chronic rhinosinusitis, nasal polyps, GORD, and aspirin intolerance (all p < 0.05) than patients without exacerbations. When we selected patients without relevant comorbidities (upper airways disease, GORD, obesity, aspirin intolerance) and not currently smoking (N = 73), the percentage of well or partially controlled asthmatics was significantly higher than in patients with comorbidities (84.9% vs 71.1%, p = 0.02); the rate of asthmatics without exacerbations in the last year was also higher (73.6% vs 51.1%, p = 0.001). During omalizumab treatment, a high percentage of asthmatics obtain a good or partial control of asthma. Comorbidities are associated with the lack of asthma control and persistence of exacerbations.
authors.affiliation: Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Italy. Electronic address: f.c.78@libero.it.
authors.forename: Federica
authors.initials: F
authors.lastname: Novelli
authors.affiliation: Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Italy. Electronic address: manuela.latorre@yahoo.it.
authors.forename: Manuela
authors.initials: M
authors.lastname: Latorre
authors.affiliation: Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Italy. Electronic address: verguraletizia@gmail.com.
authors.forename: Letizia
authors.initials: L
authors.lastname: Vergura
authors.affiliation: Chair and School of Allergology and Clinical Immunology, University of Foggia, Italy. Electronic address: mariafilomena.caiaffa@unifg.it.
authors.forename: Maria Filomena
authors.initials: MF
authors.lastname: Caiaffa
authors.affiliation: Department of Experimental and Clinical Medicine, University of Firenze, Italy. Electronic address: gianna.camiciottoli@unif.it.
authors.forename: Gianna
authors.initials: G
authors.lastname: Camiciottoli
authors.affiliation: Department of Cardiologic, Thoracic and Vascular Sciences, University of Padova, Italy. Electronic address: gabriella.guarnieri@unipd.it.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Guarnieri
authors.affiliation: Department of Biomedicine, Immunoallergology Unit, AOU Careggi, Florence, Italy. Electronic address: andrea.matucci@unifi.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Matucci
authors.affiliation: Chair and School of Allergology and Clinical Immunology, University of Bari - Aldo Moro, Bari, Italy. Electronic address: l.macchia@allergy.uniba.it.
authors.forename: Luigi
authors.initials: L
authors.lastname: Macchia
authors.affiliation: Respiratory Pathophysiology Division, University-City Hospital of Padova, Italy. Electronic address: andrea.vianello@sanita.padova.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Vianello
authors.affiliation: Department of Biomedicine, Immunoallergology Unit, AOU Careggi, Florence, Italy. Electronic address: vultaggioalessandra@gmail.com.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Vultaggio
authors.affiliation: Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Italy. Electronic address: alessandro.celi@med.unipi.it.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Celi
authors.affiliation: Unit of Respiratory Clinical Pharmacology, Department of Systems Medicine, University of Torvergata, Roma, Italy. Electronic address: mario.cazzola@uniroma2.it.
authors.forename: Mario
authors.initials: M
authors.lastname: Cazzola
authors.affiliation: Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Italy. Electronic address: pierluigi.paggiaro@unipi.it.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Paggiaro
mesh_terms: D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D015897:Comorbidity; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D018836:Inflammation Mediators; D007558:Italy; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000009:adverse effects / Q000627:therapeutic use*; D012129:Respiratory Function Tests; D012720:Severity of Illness Index
chemical_list: D018927:Anti-Asthmatic Agents; D018836:Inflammation Mediators; D000069444:Omalizumab
keywords: Asthma; Comorbidities; Control; Exacerbations; Exhaled nitric oxide; Omalizumab