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Benralizumab phase III trials show positive results in severe asthma

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The SIROCCO and CALIMA trials evaluated the effect of two dosing regimens of benralizumab 30mg administered in 4-week and 8-week regimens as add-on therapy to standard-of-care medicine across primary and key secondary endpoints. Results showed:
  • Reductions in the annual rate of asthma exacerbations (up to 51%)
  • Improvement in lung function (change in FEV1 of up to 159 mL), which was seen at 4 weeks after the first benralizumab dose and sustained throughout the treatment period
  • Improvement in asthma symptoms, such as wheeze, cough, chest tightness and shortness of breath
The outcomes were demonstrated for the 8-week dosing regimen, with no additional benefit observed with 4-week dosing, which may support less-frequent dosing. In addition, post-hoc analysis showed greater improvements in exacerbation rate reduction, FEV1 and total asthma symptom scores in patients with a history of more frequent asthma exacerbations (≥ 3 in the previous year). Detailed results were published today in The Lancet for the Phase III SIROCCO and CALIMA trials.

The adverse event frequency was similar between benralizumab-treated patients versus placebo-treated patients for both SIROCCO and CALIMA (72% and 74% for all benralizumab treated patients vs. 76% and 78% for placebo-treated patients observed in SIROCCO and CALIMA, respectively). The most common (≥5%) adverse events in benralizumab-treated patients observed in SIROCCO were asthma, nasopharyngitis, upper respiratory infection, headache, bronchitis, sinusitis, influenza and pharyngitis; and in CALIMA were nasopharyngitis, asthma, bronchitis, upper respiratory tract infection, headache and sinusitis.
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Occurred on:
Sep 05, 2016
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Related Keywords Severe Asthma, Benralizumab, Influenza, Pharyngitis