title: Omalizumab management beyond clinical trials: the added value of a network model.
abstract: BACKGROUND
  Omalizumab is effective and safe in severe allergic asthma. Few data are available about its impact on lung function and on asthma comorbidities, long-term follow-up of treated patients, adherence, non-responders profile, and optimal treatment duration.
  
  
  OBJECTIVE
  We aimed at evaluating omalizumab-related clinical outcomes and unmet needs in a real-life setting.
  
  
  METHODS
  We created a collaborative network (NEONet - North East Omalizumab Network) involving 9 Allergy and Respiratory referral centres for severe asthma placed in the North-East of Italy. Patients' data were entered into a common study database shared by all the participating physicians. A preliminary retrospective analysis was performed.
  
  
  RESULTS
  Patients come from a common well-defined geographical and environmental district providing a homogeneous population sample. A moderate but statistically significant improvement of the FEV1, and an increasing proportion of exacerbations-free patients were observed since the treatment start. These findings were independent of the baseline severity of bronchial obstruction. A positive impact of omalizumab on rhinitis in patients with both asthma and rhinitis was detected. Moreover the efficacy of omalizumab on asthma seemed not to be affected by the baseline severity of rhinitis.
  
  
  CONCLUSIONS
  Our retrospective analysis represents a preliminary report from the NEONet activity. It confirmed omalizumab efficacy and provided some new insights about its impact on lung function and on comorbid rhinitis. The network approach, under a prospective view, allows creating a large uniform database, by means of a standardized shared tool for data collecting, and joining a multidisciplinary expertise.
authors: Allergy Unit, Verona University and General Hospital, Verona, Italy. Electronic address: ma.caminati@gmail.com.
authors: Marco
authors: M
authors: Caminati
authors: Allergy Unit, Verona University and General Hospital, Verona, Italy. Electronic address: gianenrico.senna@ospedaleuniverona.it.
authors: Gianenrico
authors: G
authors: Senna
authors: Respiratory Pathophysiology Division, University-City Hospital of Padua, Padua, Italy. Electronic address: fulvia.chiecobianchi@gmail.com.
authors: Fulvia
authors: F
authors: Chieco Bianchi
authors: Respiratory Pathophysiology Division, University-City Hospital of Padua, Padua, Italy. Electronic address: mariarita.marchi@sanita.padova.it.
authors: Maria Rita
authors: MR
authors: Marchi
authors: Respiratory Pathophysiology Division, University-City Hospital of Padua, Padua, Italy. Electronic address: avianello@qubisoft.it.
authors: Andrea
authors: A
authors: Vianello
authors: Respiratory Unit, Mater Salutis Hospital, Legnago, Verona, Italy. Electronic address: micheletto.claudio@libero.it.
authors: Claudio
authors: C
authors: Micheletto
authors: Respiratory Unit, Sacro Cuore Don Calabria General Hospital, Negrar, Verona, Italy. Electronic address: carlo.pomari@sacrocuore.it.
authors: Carlo
authors: C
authors: Pomari
authors: Respiratory Unit, Orlandi General Hospital, Bussolengo, Verona, Italy. Electronic address: stognella@gmail.com.
authors: Silvia
authors: S
authors: Tognella
authors: Respiratory Pathophysiology Division, University-City Hospital of Padua, Padua, Italy. Electronic address: fsavoia@ulss.tv.it.
authors: Francesca
authors: F
authors: Savoia
authors: Data Management and Biostatistics Unit, Medi Service, Genoa, Italy. Electronic address: valentina.mirisola@mediservice.it.
authors: Valentina
authors: V
authors: Mirisola
authors: Pulmonary Unit, Verona University and General Hospital, Verona, Italy. Electronic address: andrea.rossi@ospedaleuniverona.it.
authors: Andrea
authors: A
authors: Rossi
mesh_terms: D000328:Adult; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D003299:Cooperative Behavior; D003625:Data Collection / Q000379:methods; D016208:Databases, Factual; D005260:Female; D005541:Forced Expiratory Volume; D006301:Health Services Needs and Demand; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D017146:Models, Organizational; D000069444:Omalizumab / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D065631:Rhinitis, Allergic / Q000188:drug therapy; D012720:Severity of Illness Index
chemical_list: D018927:Anti-Asthmatic Agents; D000069444:Omalizumab
keywords: Allergic rhinitis; Asthma comorbidities; Lung function; Omalizumab; Severe allergic asthma; Treatment discontinuation