Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma

Background: A recombinant humanized anti-IgE mAb, omalizumab, forms complex es with free IgE, blocking its interaction with mast cells and basophils; a s a consequence, it might be effective in the treatment of asthma. Objective. The purpose of this study was to evaluate the efficacy and safet y of omalizumab in the treatment of inhaled corticosteroid-dependent asthma . Methods: In this phase III, double-blinded, placebo-controlled trial, 525 subjects with severe allergic asthma requiring daily inhaled corticosteroi ds were randomized to receive placebo or omalizumab subcutaneously every 2 or 4 weeks, depending on baseline IgE level and body weight. Inhaled cortic osteroid doses. were kept stable over the initial 16 weeks of treatment and tapered during a further 12-week treatment period. Results: Omalizumab treatment resulted in significantly fewer asthma exacer bations per subject and in lower percentages of subjects experiencing an ex acerbation than placebo treatment during the stable steroid phase (0.28 vs 0.54 [P=.006] and 14.6% vs 23.3% [P=.009], respectively) and during the ste roid reduction phase (0.39 vs 0.66 [P=.003] and 21.3% vs 32.3% [P=.004], re spectively). Beclomethasone dipropionate reduction was significantly greate r with omalizumab treatment than with placebo (median 75% vs 50% [P<.001]), and beclomethasone dipropionate discontinuation was more likely with omali zumab (39.6% vs 19.1% [P <.001]). Improvements in asthma symptoms and pulmo nary function occurred along with a reduction in rescue beta -agonist use. Omalizumab was well tolerated, with an adverse-events profile similar to th at of placebo. Conclusion: The addition of omalizumab to standard asthma therapy reduces a sthma exacerbations and decreases inhaled corticosteroid and rescue medicat ion use.