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

The clinical benefit and steroid-sparing effect of treatment with the antii mmunoglobulin-E (IgE) antibody, omalizumab, was assessed in patients with m oderate-to-severe allergic asthma. After a run-in period, 546 allergic asthmatics (aged 12-76 yrs), symptomati c despite inhaled corticosteroids (500-1,200 mug daily of beclomethasone di propionate), were randomized to receive double-blind either placebo or omal izumab every 2 or 4 weeks (depending on body weight and serum total IgE) su bcutaneously for 7 months. A constant beclomethasone dose was maintained du ring a 16-week stable-steroid phase and progressively reduced to the lowest dose required for asthma control over the following 8 weeks. The latter do se was maintained for the next 4 weeks. Asthma exacerbations represented th e primary variable. Compared to the placebo group, the omalizumab group showed 58% fewer exacer bations per patient during the stable-steroid phase (p <0.001). During the steroid-reduction phase, there were 52% fewer exacerbations in the omalizum ab group versus the placebo group (p <0.001) despite the greater reduction of the beclomethasone dosage on omalizumab (p <0.001). Treatment with omali zumab was well tolerated. The incidence of adverse events was similar in bo th groups. These results indicate that omalizumab therapy safely improves asthma contr ol in allergic asthmatics who remain symptomatic despite regular use of inh aled corticosteroids and simultaneous reduction in corticosteroid requireme nt.