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Clinical Summary

Omalizumab improves lung function in adolescents with allergic asthma

Takeaway

  • In adolescents with moderate-to-severe uncontrolled asthma, omalizumab was associated with significant improvement in lung function and reduction in eosinophil counts.

Why this matters

  • Findings highlight the potential effect of omalizumab in patients who remain uncontrolled on current therapies and the need for optimizing treatment early in the disease course.

Study design

  • Post-hoc analysis of 8 randomised studies including 340 adolescents who were randomly assigned to receive either omalizumab (n=203) or placebo (n=137) every 2 and 4 weeks for a period between 6 and 12 months.
  • Funding: Genentech, Inc. and others.

Key results

  • Treatment with omalizumab vs placebo was associated with an increase in all baseline lung function:
    • Least squares mean (LSM) change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1): 3.0%; 95% CI, 0.2%-5.7%; P=.035
    • LSM change from baseline in FEV1: 120.9 mL; 95% CI, 30.6-211.2 mL; P=.009 and
    • LSM change from baseline in forced vital capacity: 101.5 mL; 95% CI, 8.3-194.6 mL; P=.033.
  • Reduction in eosinophil counts was greater with omalizumab vs placebo with an LSM treatment difference of −85.9 cells/μL; 95% CI, −137.1 to −34.6 cells/μL; P=.001).

Limitations

  • Post hoc analysis.

References


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