2058 Omalizumab add-on therapy reduces exacerbations among responders: A pooled NNT analysis from 5 phase 3 studies

Monday, 8 December 2014
Exhibition Hall-Poster Area (Sul America)

Ismail Kasujee , Medical Affairs, Novartis Pharma AG, Basel, Switzerland

Giovanni Bader , Medical Affairs, Novartis Pharma AG, Basel, Switzerland

Background:

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 physician's global evaluation of treatment effectiveness (GETE) tool after 16 weeks of therapy. This post-hoc pooled analysis investigated the effect of omalizumab versus placebo on exacerbations in GETE responders (patients with good/excellent rating).

Methods:

Data from 5 randomized, double-blind, placebo-controlled phase 3 studies were pooled and annualized clinically significant exacerbation (any worsening of asthma considered by the treating physician to require systemic corticosteroids) rates were analyzed in GETE responders and non-responders to omalizumab and placebo therapy. The number needed-to-treat (NNT) to save one exacerbation in 1 year was calculated.

Results:

Omalizumab significantly reduced the annualized clinically significant exacerbation rate in responders (n=553; 0.49) by 63 %versus the overall placebo group (n=801; 1.33; p<0.0001) and by 51 %versus the placebo responders (n=306; 1.00; p<0.01). The NNT to save one clinically significant exacerbation in 1 year for omalizumab was 1.19 versus the overall placebo group and 1.96 versus placebo 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.