, Volume 74, Issue 5, pp 535-537
Date: 02 Apr 2014

Omalizumab: Stepping Outside Our Comfort Zone to Broaden the Number of Those Who Can Benefit

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An increasing body of evidence indicates that omalizumab, a recombinant humanised IgG1 non-complement-fixing monoclonal antibody that binds to the high-affinity receptor-binding domain (Cε3) on the Fc portion of free IgE, is clinically effective in patients with intrinsic asthma [13], which, by definition, is asthma without atopy and, consequently, without clinical or serological evidence of IgE-mediated allergy to common environmental agents [4], and also in other morbid conditions not associated with IgE [5]. This evidence is surprising because IgE represents the substrate on which omalizumab acts. However, the possibility of also using omalizumab in non-atopic patients is extremely exciting because about one-third of adult asthmatic patients are non-atopic, and these patients usually have more severe and difficult-to-control disease [6].

Unfortunately, the current strict labelling rules do not allow us to use omalizumab beyond atopic asthma. European labelling for omalizumab specifi