Inpharma 1659 - 11 Oct 2008

Omalizumab attacks paediatricasthma

Asthma is the most common chronic illness inchildhood and, in some countries, up to 20% of childrenhave the condition. Importantly, 78% of those withasthma have high IgE levels. A novel agent developed totake advantage of IgE-associated asthma, omalizumab[Xolair], has now demonstrated promising efficacy inchildren aged 6–11 years with moderate-to-severechronic asthma. More specifically, results of a phase IIIstudy, presented at the Annual Meeting of the EuropeanRespiratory Society [Berlin, Germany; October 2008],revealed 31% fewer clinically significant exacerbationsof asthma among omalizumab recipients than amongthose receiving placebo.

Omalizumab takes on IgEOmalizumab is a chimeric monoclonal antibody that

binds to IgE. IgE plays a major role in allergic disease,causing the release of histamine and other inflammatorymediators from mast cells. Omalizumab binds to andneutralises circulating IgE by preventing IgE frombinding to its high-affinity mast-cell receptor.Importantly, the action of omalizumab leads toprevention of the onset of symptoms such as wheezingand shortness of breath in severely affected patients.

Asthma under attackIn a study presented this month at the ERS annual

meeting, omalizumab was found to significantly reduceasthma attacks in children aged 6–11 years.1 In thisdouble-blind, placebo-controlled, phase III study,628 children with moderate-to-severe persistent allergicasthma who were on an optimised asthma careprogramme, were randomised to receive SComalizumab 75–300mg every 4 weeks or 225–375mgevery 2 weeks or placebo. During the first 24 weeks’treatment, patients received fixed-dose corticosteroidtreatment, with such treatment able to be adjusted asrequired for the subsequent 28-week period. Theprimary efficacy endpoint was the rate of clinicallysignificant asthma exacerbations.

After 24 weeks’, patients receiving omalizumab werefound to experience 31% fewer clinically significantexacerbations than patients receiving placebo(p = 0.007), thus meeting the study’s primary endpoint.Furthermore, over the full year of the study, thosechildren receiving omalizumab treatment experienced54.2% fewer exacerbations than those on placebo(p < 0.001). In terms of safety, omalizumab wasgenerally well tolerated with no major differences inadverse events between omalizumab and placebo.

"These data represent an important new approach totreating allergic asthma in children who remainuncontrolled despite their treatment," commentedProfessor Bobby Lanier (University of North TexasHealth Science Center, US).1. Novartis. New Study Shows Potential Benefits of Innovative Xolair(R) Anti-IgE

Therapy in Treating Children Suffering From Moderate-to-Severe AllergicAsthma. Media Release : 6 Oct 2008. Available from: URL: http://www.novartis.com.

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Inpharma 11 Oct 2008 No. 16591173-8324/10/1659-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved