Omalizumab add-on therapy reduces exacerbations among responders: A pooled NNT analysis from 5 phase 3 studies

Introduction Omalizumab, an anti-IgE monoclonal antibody is recommended for long-term treatment of patients with moderate-to-severe allergic asthma that are identified by the physician9s global evaluation of treatment effectiveness (GETE) tool after 16 weeks of therapy. This post-hoc pooled analysis investigated the effect of omalizumab vs. placebo (PBO) on exacerbations in GETE responders (patients with good/excellent rating). Methods Data from 5 randomised, double-blind, placebo-controlled phase 3 studies were pooled and annualised clinically significant exacerbation (any worsening of asthma considered by the treating physician to require systemic corticosteroids) rates were analysed in GETE responders and non-responders to omalizumab and PBO therapy. The number needed-to-treat (NNT) to save one exacerbation in 1 year was calculated. Results Omalizumab significantly reduced the annualised clinically significant exacerbation rate in responders (n=553) by 63% vs. the overall PBO group (n=801) and by 51% vs. the PBO responders (n=306; Figure). The NNT to save one clinically significant exacerbation in 1 year for omalizumab was 1.19 vs. the overall PBO group and 1.96 vs. PBO responders. Conclusions Omalizumab responders, as identified by GETE, are associated with significantly lower exacerbations rates compared with those on placebo. GETE is a tool that can help identify those who benefit from omalizumab therapy.