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Severe asthma: omalizumab is not appropriate

The effectiveness of omalizumab is dubious and it can cause serious adverse effects. It is preferable not to use it as a long-term treatment for asthma.

Omalizumab is a new drug approved for severe persistent allergic asthma, to be used in addition to the long-term treatment when the latter is not considered sufficiently effective. The clinical evaluation data, which look complex, in fact comprise just one main trial involving only 419 patients and including important sources of bias: non-similarity of the groups being compared, a trial that only lasted 28 weeks, etc. On sale in several European countries and in the USA, omalizumab is giving rise to the same reservations everywhere: evidence of patient benefits is unconvincing and too uncertain. At best it appears to avoid one emergency consultation per patient treated over a period of 3 years, whereas it exposes patients to sometimes serious adverse effects, in particular very serious allergic reactions (requiring medical intervention), risks of infection, etc. Furthermore, there are a number of long-term unknowns, especially with regard to a possible increased risk of cancer.

In patients suffering daily asthma attacks with frequent exacerbations and restriction of their activities, it is better to adapt existing treatments to the patient’s individual needs.

©Prescrire April 2007

Source: "Omalizumab – Xolair°. Asthme : trop d’inconnues pour un anti-IgE" Rev Prescrire 2007 ; 27 (282) : 245-248. - More articles in Prescrire's "Spotlight"...