Inpharma 1304 - 8 Sep 2001

Omalizumab corticosteroid-sparingin paediatric allergic asthma

Omalizumab* has corticosteroid-sparing effects inchildren with allergic asthma, according to researchersfrom the US.

This multicentre study involved 334 such patients(aged 5–12 years) whose asthma was well controlled byinhaled corticosteroids.** During the initial 4- to 6-weekrun-in phase, patients were switched to, or remained on,inhaled beclomethasone 168–420 µg/day. Patients werethen randomised to receive SC omalizumab 150 or300mg every 4 weeks, or 225, 300 or 375mg every 2weeks (n = 225), or placebo (109). Beclomethasonedosages were maintained for 16 weeks, then graduallytapered during the 12-week corticosteroid dose-reduction phase, until total elimination was achieved ora minimum effective dosage was reached.

Greater reduction of corticosteroid dosagesThe median reduction from baseline in

beclomethasone dosage was significantly greater in theomalizumab group than in the placebo group (100 vs66.7%). Withdrawal of inhaled corticosteroids waspossible in a significantly higher proportion ofomalizumab, compared with placebo, recipients (55 vs39%).

During the corticosteroid dose-reduction phase, theomalizumab group, compared with the placebo group,had a significantly lower incidence of asthmaexacerbations (18.2 vs 38.5% of patients) and meanfrequency of exacerbations requiring doubling of thebeclomethasone dosage or systemic corticosteroids(0.42 vs 2.72 episodes/patient).

Adverse events judged as being related to the studydrug occurred in a significantly greater proportion ofomalizumab, compared with placebo, recipients (6.2 vs0.9%); in the omalizumab group, these includedurticaria, rash, flushing and pruritis.* Genentech, Novartis, Tanox; preregistration for allergic asthma andallergic rhinitis** The study was supported by Genentech, Inc and NovartisPharmaceuticals Corporation.

Milgrom H, et al. Treatment of childhood asthma with anti-immunoglobulin Eantibody (omalizumab). Pediatrics Electronic Pages [serial online] 108: e36, Part 1,Aug 2001. Available from: URL: http://www.pediatrics.org 800879089

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Inpharma 8 Sep 2001 No. 13041173-8324/10/1304-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved