Omalizumab management beyond clinical trials: the added value of a network model

Pulm Pharmacol Ther. 2014 Oct;29(1):74-9. doi: 10.1016/j.pupt.2014.01.007. Epub 2014 Feb 6.

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.

Conclusion: 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.

Keywords: Allergic rhinitis; Asthma comorbidities; Lung function; Omalizumab; Severe allergic asthma; Treatment discontinuation.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Anti-Asthmatic Agents / adverse effects
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Cooperative Behavior*
  • Data Collection / methods
  • Databases, Factual
  • Female
  • Forced Expiratory Volume
  • Health Services Needs and Demand
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Models, Organizational
  • Omalizumab / adverse effects
  • Omalizumab / therapeutic use*
  • Retrospective Studies
  • Rhinitis, Allergic / drug therapy
  • Severity of Illness Index

Substances

  • Anti-Asthmatic Agents
  • Omalizumab