The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics

Abstract

The clinical benefit and steroid-sparing effect of treatment with the antiimmunoglobulin-E (IgE) antibody, omalizumab, was assessed in patients with moderateto-severe allergic asthma.After a run-in period, 546 allergic asthmatics (aged 12-76 yrs), symptomatic despite inhaled corticosteroids (500-1,200 mg daily of beclomethasone dipropionate), were randomized to receive double-blind either placebo or omalizumab every 2 or 4 weeks (depending on body weight and serum total IgE) subcutaneously for 7 months. A constant beclomethasone dose was maintained during a 16-week stable-steroid phase and progressively reduced to the lowest dose required for asthma control over the following 8 weeks. The latter dose was maintained for the next 4 weeks. Asthma exacerbations represented the primary variable.Compared to the placebo group, the omalizumab group showed 58% fewer exacerbations per patient during the stable-steroid phase (pv0.001). During the steroid-reduction phase, there were 52% fewer exacerbations in the omalizumab group versus the placebo group (pv0.001) despite the greater reduction of the beclomethasone dosage on omalizumab (pv0.001). Treatment with omalizumab was well tolerated. The incidence of adverse events was similar in both groups.These results indicate that omalizumab therapy safely improves asthma control in allergic asthmatics who remain symptomatic despite regular use of inhaled corticosteroids and simultaneous reduction in corticosteroid requirement.

Randomized Trial of Omalizumab (Anti-IgE) for Asthma in Inner-City Children

“…[3][4][5][6][7][8][9] Anti-IgE treatment reduces exacerbations, symptoms and, in some patients, the dose of inhaled glucocorticoids needed to maintain disease control. [4][5][6][7][8][9] Because of the increased morbidity associated with a high prevalence of allergic sensitization and the heavy burden of allergen exposure among inner-city residents, 10,11 this population in particular may benefit from an IgE-targeted treatment. We hypothesized that the addition of omalizumab would improve disease control by reducing symptoms and exacerbations in inner-city children, adolescents, and young adults with persistent asthma.…”

A Pharmaco-Economic Analyzis of Treating Severe Uncontrolled Child Asthma with Omalizumab — Actual Russian Clinical Practice Data

“…По данным НЦЗД, омализумаб позволял снижать среднюю дозу ИГКС у детей. Эти данные согласуются с аналогичным эффек-том омализумаба, описанным в РКИ на популяции паци-ентов в возрасте 12 лет и старше [13]; в модель был включен размер эффекта, полученный в РКИ.…”

Le récepteur de forte affinité pour l’IgE : leçons d’une analyse structurale

“…Chez les patients ayant un asthme modéré, le traitement a réduit certaines des réponses précoces et tardives observées lors d'un test de provocation par les allergènes [31,32]. Chez des patients dont l'asthme modéré ou sévère nécessitait le recours à la corticothérapie, trois études chez des adultes [33][34][35] et une étude chez des enfants [34] ont été pratiquées. Le traitement améliorait les symptômes, entraînait une réduction de la fréquence des crises et permettait de diminuer les doses de corticoïdes, autorisant parfois l'arrêt complet de la corticothérapie.…”

“…La réduction de la corticothérapie est un avantage majeur compte tenu des effets secondaires de l'emploi des sté-roïdes au long cours, en particulier chez les enfants. En ce qui concerne les paramètres respiratoires, les résultats variaient d'une étude à l'autre, allant de l'absence d'amélioration des performances [33] à la récupéra-tion partielle de l'amplitude du souffle ou volume expiratoire forcé en 1 seconde [33][34][35]. Deux études ont été pratiquées chez des patients atteints de rhinite allergique.…”