Observational study in severe asthmatic patients after discontinuation of omalizumab for good asthma control

Respir Med. 2014 Apr;108(4):571-6. doi: 10.1016/j.rmed.2014.02.003. Epub 2014 Feb 12.


Introduction: Severe persistent asthma represents a major and costly public health issue. There is evidence that long-term treatment with omalizumab might have disease-modifying activity but data on the consequences of discontinuing treatment after a positive response are limited. The purpose of this study was to investigate-in real-life prescribing conditions-what happens when omalizumab is discontinued in patients with severe, persistent allergic asthma who have responded well to omalizumab treatment.

Methods: An observational, descriptive, cross-sectional, retrospective study to establish the time to loss of asthma control after the discontinuation of courses of omalizumab treatment of varying duration.

Results: 24 lung specialists reviewed data from 61 responder patients who had discontinued omalizumab after a mean duration of 22.7 ± 13.1 [range: 2.5; 59.5] months of treatment. Loss of asthma control was documented in 34 patients (55.7%) with a median interval between discontinuation and loss of control of 13.0 months (mean 20.4 ± 2.6 [95% CI: 8.3-28.1]). No correlation was detected between time to loss of control and duration of treatment, although control tended to be sustained for longer in patients whose response had been classified as "excellent" as opposed to "good" (median: 17.0 vs. 12.8 months; NS).

Discussion: The discontinuation of omalizumab was not associated with any rebound effect or exacerbation of the disease, and control was sustained throughout the follow-up period of at least 6 months in nearly half of all patients, including all of those who had been treated for 3.5 years or more. After the reintroduction of omalizumab, 4 out of 20 patients did not respond again.

Keywords: Asthma control; Discontinuation; Duration of treatment; Omalizumab.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Asthmatic Agents / administration & dosage*
  • Anti-Asthmatic Agents / therapeutic use
  • Antibodies, Anti-Idiotypic / administration & dosage*
  • Antibodies, Anti-Idiotypic / therapeutic use
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Child
  • Drug Administration Schedule
  • Female
  • Forced Expiratory Volume / drug effects
  • Humans
  • Male
  • Middle Aged
  • Omalizumab
  • Recurrence
  • Remission Induction
  • Retrospective Studies
  • Time Factors
  • Treatment Outcome
  • Withholding Treatment
  • Young Adult


  • Anti-Asthmatic Agents
  • Antibodies, Anti-Idiotypic
  • Antibodies, Monoclonal, Humanized
  • Omalizumab