title: Can the response to Omalizumab be influenced by treatment duration? A real-life study.
abstract: It is unknown whether Omalizumab effectiveness changes over the course of time. Our retrospective real-life study tried to analyze whether Omalizumab response may be influenced by treatment duration.
  
  
  
  340 severe asthmatics treated with Omalizumab for different periods of time were recruited. They were subdivided into 4 groups according to the Omalizumab treatment length: <12, between 12 and 24, between 24 and 60 and >60 months. Omalizumab treatment results (FEV1, exacerbations, ACT, SABA use, asthma control levels, medications used e and ICS doses) were compared.
  
  
  
  ACT, exacerbations, GINA control levels, ICS doses and SABA use were similar in all groups with different Omalizumab treatment durations. Using a linear regression model, corrected for all confounding variables, a higher significant positive increase in FEV1% in subjects treated for 12-24 (β = 9.49; p = 0.034) or 24-60 months (β = 8.56; p = 0.043) was found when compared with subjects treated for a shorter period. Treatment duration was positively associated with a step down of the other associated therapies (OR: 1.013; p = 0.019). This association was more relevant (OR: 4.167; p = 0.005) when we considered Omalizumab treatment duration >60 months compared to the shorter therapy. In particular, the percentage of subjects that were taking Montelukast, LABAs and oral corticosteroids was lower in the group treated with Omalizumab for a longer period of time.
  
  
  
  In real-life, the positive Omalizumab response remained stable for over 60 months. Long term Omalizumab treatment may lead to a discontinuation of some associated medications and to a slowing down of FEV1decline.
authors.affiliation: Pneumologia, Ospedale Misericordia, Grosseto, Italy. Electronic address: bsposat@tin.it.
authors.forename: Bruno
authors.initials: B
authors.lastname: Sposato
authors.affiliation: Istituto di Fisiologia Clinica, CNR, Pisa, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Scalese
authors.affiliation: Cardio Thoracic and Vascular Department, Pathophysiology Unit, University of Pisa, Italy.
authors.forename: Manuela
authors.initials: M
authors.lastname: Latorre
authors.affiliation: Cardio Thoracic and Vascular Department, Pathophysiology Unit, University of Pisa, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Novelli
authors.affiliation: DIMPEFINU, Unit of Pneumology and Medicine, University of Palermo, Palermo, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Scichilone
authors.affiliation: Pneumologia, Ospedale S.Corona, Pietra Ligure, Italy.
authors.forename: Manlio
authors.initials: M
authors.lastname: Milanese
authors.affiliation: Pneumologia, Ospedale Misericordia, Grosseto, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Olivieri
authors.affiliation: Pneumologia, Ospedale Misericordia, Grosseto, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Perrella
authors.affiliation: Cardio Thoracic and Vascular Department, Pathophysiology Unit, University of Pisa, Italy.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Paggiaro
mesh_terms: D000085:Acetates / Q000008:administration & dosage; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D003521:Cyclopropanes; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000008:administration & dosage* / Q000627:therapeutic use; D011804:Quinolines / Q000008:administration & dosage; D012189:Retrospective Studies; D013440:Sulfides; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D000069444:Omalizumab; C093875:montelukast
keywords: Effectiveness; Omalizumab; Real-life; Response; Severe asthma; Treatment duration